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Page 1: Facilitators Guide - CCGDMccgdm.org/dw/CCGDMCycleII/FG CCGDM Cycle II.pdf · Public Health Foundation of India (PHFI) and Dr. Mohan’s Diabetes Education Academy (DMDEA) do not recommend
Page 2: Facilitators Guide - CCGDMccgdm.org/dw/CCGDMCycleII/FG CCGDM Cycle II.pdf · Public Health Foundation of India (PHFI) and Dr. Mohan’s Diabetes Education Academy (DMDEA) do not recommend
Page 3: Facilitators Guide - CCGDMccgdm.org/dw/CCGDMCycleII/FG CCGDM Cycle II.pdf · Public Health Foundation of India (PHFI) and Dr. Mohan’s Diabetes Education Academy (DMDEA) do not recommend

Facilitators Guide

Disclaimer

Public Health Foundation of India (PHFI) and Dr. Mohan’s Diabetes Education Academy (DMDEA) do not recommend or provide individualized medical diagnosis, treatment or advice, nor do they recommend specific therapies or prescribe medication for anyone using or consulting this publication. The information contained in this publication is intended for general educational and informational purposes only.

Medical information changes rapidly. Therefore, PHFI and DMDEA assume no responsibility for how readers use the information contained in this publication and hence assume no legal liability or responsibility arising out of use of this information.

Contents included in this module are solely provided by designated experts and represents their viewpoints entirely.

© Copyright 2014 Public Health Foundation of India, New Delhi & Dr. Mohan’s Diabetes Education Academy, Chennai. All rights reserved.

This training material (including print material, CDs, Modules and presentations) is the exclusive intellectual property right of PHFI and DMDEA. No part of this training material may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of PHFI and DMDEA.

Layout, designed & printed byMehra Impressions (www.mehraimpressions.com)WZ 102, Tihar Village, Opp. Subhash Nagar, New Delhi-110018, India

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ContentsIntroduction

Module I Introduction to Diabetes in Pregnancy

Module II Screening and Diagnosis of Gestational Diabetes Mellitus

Module III Management of Diabetes in Pregnancy - Part I

Module IV Management of Diabetes in Pregnancy - Part II

Appendix Assignments, Assessments and Criteria for Award of Certificate

5

7

13

19

25

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Introduction to Certificate Course in Gestational Diabetes Mellitus (CCGDM) Cycle II

Introduction

On behalf of Public Health Foundation of India and Dr. Mohan’s Diabetes Education Academy, we wish you a warm welcome to the Certificate Course in Gestational Diabetes Mellitus (CCGDM) Cycle II. We congratulate you on having been selected to deliver this course in your city and thank you for agreeing to spare your valuable time to ensure the success of this course.

The CCGDM is designed to equip general practitioners, physicians and obstetrician / gynecologists with the information and tools needed to manage Gestational Diabetes Mellitus (GDM) and pre-existing diabetes in pregnancy in a clinical setting. The Course will be delivered on a Modular basis. There are four Modules, each of which will be delivered on a fixed Sunday every month as per the standardized calendar. Presence of both the faculty is compulsory for the conduction of all 4 sessions in their designated centre.

The Modules consist of: y Learning objectives

y Pre-test

y Teaching slides

y Case studies

y Take home messages

y Post test

y Primer to the next module

The day’s discussions start with listing of the learning objectives. At this point, you can make the session more interactive by providing a case discussion, either provided by yourself or by the trainees.

This is then followed by the pre-test. This consists of ten multiple choice questions (MCQs) based on the topic to be covered during the particular session. This is designed to assess the trainees’ baseline knowledge. The questions as well as the answer keys are provided elsewhere in this booklet. Since the same set of MCQs will be administered as the post-test at the end of the session, it is imperative that you do not share the answers with the trainees at this juncture.

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The teaching slides have been designed to be as interactive as possible. Please take sufficient time to clarify each point of interest with the trainees. A number of case studies have also been interspersed among the slides. Please remember that there may not be any “right” or “wrong” answer for many of these; they are only meant to provoke thought and discussion.

At the end of the presentation, please arrange for the trainees to attempt the post-test. After they have completed the MCQs, you can share the answers with them and discuss further, if needed. The pre-test and post-test scores of each trainee for each Module need to be recorded and sent to the CCGDM Secretariat based at PHFI, New Delhi. Further details are available elsewhere in the Guide.

In addition to this, the trainees are also expected to submit certain Interim Assignments at specified points of time during the course. These are detailed in the Appendix.

There will also be an Exit Exam in the form of MCQs at the completion of Module IV, a minimum of 50% marks is required to pass, which will be one of the criteria for award of the certificate. Further details will be communicated to you closer to the date of the Exam.

The Curriculum for the CCGDM has been designed with inputs from eminent Endocrinologists, Diabetologists and Obstetrician/ Gynecologists who have agreed to act as the National Expert Panel for this Course. We are thankful to them for sharing their valuable time and invaluable expertise in designing this course. We believe that with the active participation of eminent and enthusiastic faculty like yourself, this course will prove to be a grand success as well as a milestone in GDM management in India.

We wish you a Happy Journey !

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The learning objectives of this modules are as follows:

y Learn about the evolution of the concept of diabetes in pregnancy

y Review the metabolic alterations occurring in pregnancy and how these can lead to diabetes

y Define GDM and discuss its epidemiology

y Learn about the consequences of GDM to the mother and fetus

To achieve these objectives, the day’s discussions are organized as follows:

y Self-Introduction by the Trainer and Trainees

y Pre-test

y Lecture 1: Historical perspective of GDM

y Lecture 2: Pathogenesis of GDM

y Lecture 3: Risk factors of GDM

y Lecture 4: Implications of GDM

y Lecture 5: Epidemiology of GDM

y Post-test

y Primer to Module II

Self-Introduction by trainer and trainees

Before you start with the day’s proceedings, it is important for the trainees and you to get to know each other. This self- introduction will help break the ice and will enable you to assess their backgrounds, so that you and your co-faculty can decide which areas of the curriculum need to be stressed upon.

Module I Introduction to Diabetes in Pregnancy

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Pre-test(This will also serve as post-test after the day’s session)

Choose the most appropriate answer

1. The first recorded description of gestational diabetes was made by ___A. Carpenter and CoustanB. BennewitzC. Priscilla WhiteD. Jorgen Pedersen

2. The term “Gestational Diabetes Mellitus” was introduced by ___A. Priscilla WhiteB. FreinkelC. O’ SullivanD. Blott

3. Which of the following molecules can freely traverse the placental barrier?A. GlucoseB. InsulinC. TriglyceridesD. Glucagon

4. Regarding early pregnancy, all the following are true exceptA. There is beta cell hyperplasiaB. The second phase insulin secretion is increasedC. Insulin sensitivity is usually unchangedD. There occurs a reduction in fasting plasma glucose levels

5. The most important hormone contributing to insulin resistance in pregnancy is _____A. CortisolB. EstrogenC. Human placental lactogenD. Progesterone

6. Which of the following is not a risk factor for GDM?A. Family history of diabetesB. Marked obesityC. Age below 25 years

D. PCOS

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7. The cut-off for macrosomia in India is generally accepted to beA. 3 kgB. 3.5 kgC. 4 kgD. 4.5 kg

8. Which of the following neonatal complications is likely to occur days to weeks (as opposed to hours) after birth?A. HyperbilirubinemiaB. HypoglyclemiaC. HypercalcemiaD. Polycythemia

9. Which of the following figures would be a best estimate of the prevalence of GDM in India?A. 5%B. 15%C. 30%

D. 50%

10. Which of the following may not be an important cause of still birth in GDM?A. Congenital malformationsB. Excess fetal growthC. Fetal growth restrictionD. All the above are equally important

Answer Key:

1- B, 2- C, 3- A, 4- B, 5- C,

6- C, 7- B, 8- A, 9- B, 10- A

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Module I: Introduces the topic of diabetes in pregnancyThe first few slides deal with the history of this important topic. Some of the illustrious names who have contributed to the field such as Priscilla White, Pedersen, Freinkel, O’ Sullivan and Carpenter and Coustan have been acknowledged here.

We follow this with a discussion on the pathogenesis of diabetes in pregnancy. The alterations occurring in glucose metabolism during pregnancy are detailed here. This is important to understand since these alterations also underline the worsening of glycemic status in pre-existing diabetes in pregnancy. It is also important to understand that “true” GDM (diabetes caused by pregnancy) almost never occurs during early pregnancy; diabetes diagnosed at this stage is more likely to be previously undiagnosed type 2 diabetes.

The implications of diabetes in pregnancy to the mother and fetus are explained next. We will be going back to this in a subsequent module, but do use this opportunity to introduce the topic.

We finish off by describing the epidemiology of GDM. Do emphasize that data from India is patchy at present and more information is needed. Nevertheless the numbers are likely to be large, considering the ongoing epidemic of diabetes and pre-diabetes in India.

Case StudiesCase Study 1A 28 year old nongravid female has an OGTT performed as part of insurance screening. The following are her results

Time 0 hr (Fasting) 2 hour Glucose (mg/dl) 115 208

What is the diagnosis?

Case Study 2A 35 year old nongravid female with a strong family history of diabetes undergoes an OGTT. The following are her results

Time 0 hr (Fasting) 2 hour Glucose (mg/dl) 98 177

What is the diagnosis?

Case Studies 1 and 2 are intended to familiarize the trainees with the diagnosis of diabetes in the non-pregnant state. The lady in Case 1 has diabetes (as evidenced by a 2-hour value of 208 mg/dl) while the patient in Case 2 has impaired glucose tolerance (IGT) with a 2-hour value of 177 mg/dl.

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Case Study 3

Mrs. C is a 22 year old primigravida. She is 156 cm tall and weighs 51 Kg (BMI 20.9 Kg/m2). She has no family history of diabetes.

What is her risk of developing GDM?

Case Study 4Mrs. C is 33 years old. She has suffered from two miscarriages in the last three years and has earlier delivered a baby weighing 4.1 Kg. She is 160 cm tall and weighs 81 Kg (BMI 31.6 Kg/m2). Both her parents have diabetes.

What is her risk of developing GDM?

Case Studies 3 and 4 deal with the risk factors of GDM. The risk of GDM is higher in Case 4 than in Case 3; however, in the Asian Indian context, all pregnant women should be treated as having high risk of GDM.

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The learning objectives of this modules are as follows:

y Learn about the different screening protocols for GDM

y Appreciate the differences between GDM and pre-existing diabetes and their impact

To achieve these objectives, the day’s discussions are organized as follows:

y Pre-test

y Lecture 1: Screening for gestational diabetes mellitus

y Lecture 2: Diagnosis of gestational diabetes mellitus

y Lecture 3: Pre-existing diabetes and Pregnancy

y Post-test

y Primer to Module III

Pre-test(This will also serve as post-test after the day’s session)

Choose the most appropriate answer

1. In the Indian scenario, which of the following women should be screened for GDM?A. A 30 year old primigravida with a BMI of 28 kg/m2 and no family history of diabetesB. A 26 year old 2nd gravida with a BMI of 24 kg/m2 and positive family history of diabetesC. A 21 year old primigravida with a BMI of 20 kg/m2 and no family history of diabetesD. All the above women should be screened

2. When should a pregnant woman be first screened for diabetes?A. At the first antenatal visitB. At 14 to 16 weeksC. At 24 to 28 weeksD. At 28 to 32 weeks

Module II Screening and Diagnosis of Gestational Diabetes Mellitus

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3. Which is the best test to diagnose GDM?A. Random plasma glucoseB. Fasting plasma glucoseC. Oral glucose tolerance testD. HbA1c

4. All the following are true regarding IADPSG Guidelines exceptA. They have been developed based on pregnancy outcomesB. Only one abnormal value is needed for diagnosisC. Screening OGTT is recommended in first trimesterD. The cut offs for diagnosis are slightly lower than the Carpenter Coustan cut offs.

5. A woman is found to have a fasting plasma glucose of 188 mg/dl during her first antenatal checkup. What is the most likely diagnosis?A. Impaired fasting glucoseB. Gestational diabetes mellitusC. Pre-existing diabetesD. Normal

6. A 32 year old 2nd gravida undergoes a 75 g OGTT at 26 weeks of gestation. Her 2 hour post load plasma glucose value is 161 mg/dl. What is the diagnosis?A. Impaired glucose toleranceB. Gestational diabetesC. Pre-existing diabetesD. Normal

7. According to the concept of “fuel-mediated teratogenesis”, gestational diabetes is most likely to causeA. Abnormal organogenesisB. Behavioral teratologyC. Anthropometric / metabolic teratologyD. All of the above

8. The most specific congenital anomaly found in infants of diabetic mothers isA. Neural tube defectB. VSDC. Duodenal atresiaD. Sacral agenesis

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9. Which of the following is a risk factor for worsening of diabetic retinopathy during pregnancy ?A. Poor glycemic control before conceptionB. Severe retinopathy before conceptionC. Rapid normalization of blood glucose during pregnancyD. All of the above

10. Regarding diabetic nephropathy in pregnancy, all the following are true exceptA. In women with normal creatinine clearance, renal function can deteriorate during pregnancyB. It can increase the risk of maternal hypertensive complicationsC. It can increase risk of preterm deliveryD. It can cause placental insufficiency and fetal growth restriction.

Answer Key:1- D, 2- A, 3- C, 4- C, 5- C,

6- B, 7- C, 8- D, 9- D, 10- A

Module II: Introduces Screening and Diagnosis of GDM This Module deals with the important (and controversial) topic of screening and diagnosis of diabetes in pregnancy. There is little agreement among various International organisations on the ideal screening protocol for GDM. Therefore, the methodology used for screening has hitherto been a matter of convenience and personal preference. The latest International Association of the Diabetes and Pregnancy Study Groups (IADPSG) Guidelines have the advantage of being based on outcome data, but are probably not ideal for India on account of the need for three blood samples. Our teaching slides reflect the view of the National Expert Panel that the 2 hour plasma glucose after a 75 g OGTT is the most practical method of diagnosing GDM in India.

Notwithstanding the controversy over the screening and diagnostic tests, it needs to be emphasized that all Indian pregnant women need to be screened for diabetes and that this screening ought to take place as early as possible during pregnancy.

The second part of the Module focuses on the topic of pre-existing diabetes in pregnancy- a subject which is likely to assume great relevance in India as the epidemic of type 2 diabetes spreads to include women of the reproductive age group. The main differences between GDM and diabetes complicating pregnancy need to be emphasized here, as also the risk of worsening of certain chronic diabetes complications during pregnancy.

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Case StudiesCase Study 1Mrs. S is a 35 year old nulliparous lady with a bad obstetric history, having suffered two miscarriages in the last three years

She has never tested her blood glucose levels during either of her previous pregnancies

Her mother has diabetes.

• Does she need to be screened for diabetes?

• If so, when?

• What screening test is to be used?

This lady has several risk factors for diabetes and needs screening.

The first screening should be done as early as possible during pregnancy. According to the IADPSG, “conventional” criteria, i.e. fasting plasma glucose, 2 hour glucose value following a glucose challenge or a glycated hemoglobin are to be used for screening during the 1st trimester. The aim of early screning is to pick up pre-existing diabetes. The Indian DIPSI guideline recommend that a pregnant woman be tested for diabetes 2 hours after administration of 75 g oral glucose at the first antenatal visit itself

Case Study 2Mrs.Aisa22yearoldprimigravidacomingforherfirstantenatalcheckupat12weeksofgestation

On examination, she is 152 cm tall and weighs 54 kg. Her BMI is 23.3 kg/m2

She does not have a family history of diabetes

• Does she need to be screened for diabetes?

• If so, when?

• What screening test is to be used?

Even though this lady has none of the risk factors for diabetes, she still needs screening since she belongs to a high risk ethnic group.

Case Study 3Mrs. C, a 28 year old primigravida, underwent an oral glucose tolerance test (OGTT) with 100 g glucose at 26 weeks’ gestation

Her results are as follows:Time 0 hr (Fasting) 1 hour 2 hour 3 hour

Glucose (mg/dl) 86 183 162 133

• Does she have GDM?

This lady has undergone a 3 hour, 100g OGTT. She has GDM as per the Carpenter-Coustan criteria, since the 1 hour and 2 hour values are above the cut-offs.

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Case Study 4 (A)Mrs. K, a 24 year old primigravida, is screened for diabetes during the 15th week of gestation

Her results are as follows

Fasting plasma glucose= 79 mg/dl

HbA1c= 4.9%

• Does she have diabetes?

• Does she need to be retested for diabetes?

• If so, when and using what test?

Case Study 4 (B)Mrs. K undergoes an OGTT with 75 g of glucose at 25 weeks’ gestation

Her results are as follows:Time 0 hr (Fasting) 1 hour 2 hour

Glucose (mg/dl) 90 176 159

• What is the diagnosis?

This lady was found to be normal at the first screen; however, repeat screening at 26 weeks has led to a diagnosis of GDM as per IADPSG criteria.

Case Study 5 (A)Mrs. C, a 25 year old primigravida, underwent a screening oral glucose tolerance test (OGTT) with 75 g glucose at 14 weeks’ gestation

Her results are as follows:Time 0 hr (Fasting) 1 hour

Glucose (mg/dl) 86 137

• Does she have diabetes?

• Does she need to be tested again?

• If so, when?

This lady does not have diabetes. However she needs to be retested at 24 to 28 weeks of gestation.

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Case Study 5 (B)Mrs. C undergoes repeat testing at 26 weeks’ gestation

Her results are as follows:Time 0 hr (Fasting) 1 hour

Glucose (mg/dl) 88 161

• Does she have GDM?

This lady has GDM.

She can be initiated on a trial of lifestyle modification for 2 or 3 weeks.

Case Study 6Mrs.C,a32yearoldprimigravida,reportsforthefirstantenatalcheckup

She is obese with a body mass index of 35 kg/m2. Both her parents have diabetes

Her fasting plasma glucose is 192 mg/dl

Her HbA1c is 9.2%

• What type of diabetes does this patient have?

• What is the prognosis for the pregnancy and for future resolution of diabetes?

This patient has pre-existing diabetes (most probably type 2 diabetes). GDM does not usually present this early in pregnancy, and HbA1c will not be so high.

The patient will need lifestyle modification and insulin.

The prognosis for pregnancy is guarded since the sugars have been high since the time of conception. It is also unlikely that the diabetes will resolve after delivery.

A good targeted ultrasound scan (including a fetal echocardiogram) will help in this case to detect congenital anomalies.

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The learning objectives of this modules are as follows: y Appreciate the importance of pre-conception counselling in pre-existing diabetes and pre-diabetes

y Discuss the therapeutic options for diabetes in pregnancy

To achieve these objectives, the day’s discussions are organized as follows: y Pre-test

y Lecture 1: Pre-conception counselling

y Lecture 2: Need for treating GDM

y Lecture 3: Management of GDM

y Post-test

y Primer to Module IV

Pre-test(This will also serve as post-test after the day’s session)

Choose the most appropriate answer

1. All of the following are contraindications to pregnancy in diabetes exceptA. Acute coronary event in last 6 monthsB. Renal insufficiencyC. Non-proliferative retinopathyD. Uncontrolled Diabetes

2. A woman of ideal pre-pregnancy body weight can gain __ kg in weight during pregnancy.A. 3.5-5.5B. 5.5-8C. 8-11D. 11-13.5

Module III Management of Diabetes in Pregnancy - Part I

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3. Which of the following blood glucose values should prompt initiation of insulin therapy in a woman on diet therapy for GDM?A. A fasting value of 90 mg/dlB. A 1 hour postprandial value of 124 mg/dlC. A 2 hour postprandial value of 141 mg/dlD. A before lunch value of 86 mg/dl

4. Which of the following insulin preparations has not been approved for use in pregnancy?A. Insulin aspartB. Insulin lisproC. Insulin detemirD. Insulin glargine

5. Which of the following sulfonylureas has been suggested as a viable therapeutic alternative in GDM?A. GlibenclamideB. GlipizideC. GliclazideD. Glimepiride

6. Which of the following oral antidiabetic agents can be continued during pregnancy?A. PioglitazoneB. MetforminC. AcarboseD. Sitagliptin

7. For women with pre-existing type 1 diabetes the usual dose of insulin in the first trimester of pregnancy is_________A. 0.5 units/kgB. 0.7 units/kgC. 0.9 units/kgD. 1.1 units/kg

8. A woman with GDM is found to require insulin therapy. She has fasting and postprandial (after-breakfast) blood glucose levels of 80 and 158 mg/dl respectively. What would be the ideal regimen for insulin initiation?A. A single shot of bedtime NPH insulinB. Two shots of premixed insulin, one before breakfast and the other before dinnerC. A single shot of regular insulin before breakfastD. Two shots of NPH insulin

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9. A woman with GDM is started on 6 units of regular insulin before breakfast. Two weeks later, her fasting and post-breakfast blood glucose levels are 82 and 120 mg/dl respectively, but her after lunch glucose level is 161 mg/dl. What is the next line of management?A. Add a second shot of regular insulin before lunchB. Increase the dose of regular insulin before breakfastC. Switch to premix insulin before breakfastD. Add NPH insulin at bedtime

10. A pregnant woman with GDM is on 8 units of NPH insulin at bedtime and 6 units of regular insulin before breakfast. She complains of recurrent low sugar symptoms in the early hours of the day.

Which of the following steps can be expected to ameliorate her problem?A. Ensuring regular bedtime snackingB. Reducing the dose of NPHC. Switching over from NPH to long acting basal analogueD. All of the above

Answer Key: 1- C, 2- C, 3- C, 4- D, 5- A,

6- B, 7- B, 8- C, 9- A, 10- D

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Module III: Deals with dietary and pharmacological management of diabetes in pregnancy Module III deals with dietary and pharmacological management of diabetes in pregnancy. While some women with GDM can be managed with diet modification alone, the majority need insulin, as do virtually all women with pre-existing diabetes.

It is important to realize that diet in GDM needs to be individualized, based on the pre-pregnancy BMI and nutritional status. Excess weight gain has to be avoided; at the same time, too stringent restriction of calories is also not advisable. Emphasize the benefits of a team approach, including a certified dietician.

Pharmacotherapy of diabetes in pregnancy is still centred on insulin, notwithstanding the progress made on some oral antidiabetic agents in recent years. Stress to the trainees that insulin has an unmatched track record of efficacy and safety in pregnancy and will continue to be the agent of choice for the foreseeable future. While some information has been provided on glibenclamide and metformin, this is not intended to support their use as first line agents in pregnancy.

Case StudiesCase Study 1A38-year-oldobeseladywithtype2diabetesmellituspresentstoyourofficeforfollowupvisit.Herblood sugar has been well controlled on metformin. She wants to have a baby and wants to know if there is any special thing to do so that her diabetes will not affect her pregnancy.

• What would you advise her?

• What would you do regarding her antidiabetic medications?

Case Study 2Mrs. S, 28 years of age, known to have type 1 diabetes for the past 14 years comes for pre-pregnancy counseling

• What relevant history would you like to elicit?

• What examination and investigation would you do?

• How would you counsel her?

These two cases introduce the concept of preconceptional counseling. The lady in case 1 has type 2 diabetes and will need to be counseled regarding the need for insulin, among other things. The lady in case 2 has type 1 diabetes and needs to be counseled on insulin dosage adjustments. In both cases, the women need counseling on frequent self-monitoring, regular follow-up and compliance with diet and medications.

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Case Study 3A 26 year old primigravida is detected to have GDM during the 27th week of gestation. Her fasting and post-glucose load blood glucose values are 87 mg/dl and 182 mg/dl, respectively

She is 158 cm tall and weighs 91 kg. She is vegetarian. She follows a sedentary lifestyle, but “tries to go for a walk” for 15 minutes every day

What advise would you give her regarding diet and exercise?

This case is intended to introduce the topic of lifestyle modification in diabetes.

Case Study 4Mrs. K, a 34 year old 2nd gravida, is found to have GDM at 27 weeks’ gestation

Shewasputonlifestylemodification,whichshefollowsrigorously

After 2 weeks, her results were as follows:Fasting blood glucose 982 hour postprandial blood glucose 156

• Is her glycemic control adequate?

• What is the next line of treatment?

Even after trial of lifestyle modification, the postprandial sugar level is above target. She can be started on a small dose of prandial insulin.

Case Study 5Mrs. SA, a 28 year old 2nd gravida, undergoes an OGTT with 100 g of glucose at 24 weeks’ gestation

Her results are as follows:Fasting 1 hour 2 hour 3 hour

Plasma Glucose (mg/dl) 138 259 217 198

What treatment would you advise?

• Diet and exercise?

• Metformin?

• Insulin?

This lady probably has pre-existing diabetes, as suggested by the high fasting blood glucose levels. As such, it is unlikely that she will respond to lifestyle modification alone. She will most likely need insulin.

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Case Study 6Mrs. K is put on 4 units of rapid acting insulin before breakfast and advised to monitor her blood sugars daily. She does well

After 2 weeks, her reports are as follows, She is compliant with diet, exercise and insulin.Fasting blood glucose (mg/dl) 1182 hour postprandial blood glucose (mg/dl) 126

• Is her glycemic control adequate?

• What is the next line of treatment?

This case study follows up the lady from Case 4. Here the fasting sugar levels are high. The patient will need to be put on NPH insulin at bedtime.

Case Study 7A 24- year- old primigravida with type 1 diabetes on multiple daily insulin injection regimen presents toyourofficeforafollowupvisit.Herpre-breakfastglucoseaveraged285mg/dL;pre-dinnertimewas95mg/dLand68mg/dLat3AM

How will you treat her diabetes?

This is a lady with type 1 diabetes who has low blood glucose levels at 3 a.m. and high pre-breakfast levels. This is an example of Somogyi syndrome (post-hypoglycemic hyperglycemia). The solution would be to avoid the nocturnal dip in the glucose levels by reducing the night dose of long-acting insulin and by ensuring bedtime snacking.

Case Study 8Mrs. J, a 32 year old lady, has type 2 diabetes of 6 years’ duration.She is on treatment with a combination of Glibenclamide and Metformin.She has recently learnt that she is pregnant.Herlabreportsare:FPG=80mg/dl,PPG=118mg/dl;HbA1c=6.1%You advise her to switch over to insulin but she is not keen.

What would you tell her?

This case introduces the topic of oral antidiabetic agents in pregnancy. While many studies have shown the safety and efficacy of these agents in pregnancy, their most compelling indication as of now remains patient refusal to take insulin.

Case Study 9Mrs. B, a 31 year old primigravida, is diagnosed with diabetes during the 12th week of gestation

She has been on metformin (for polycystic ovarian disease) for the past 4 years

• Can metformin be continued during pregnancy?

• If so, till what time?

Metformin can be continued till the end of 1st trimester. There is some evidence to show that it can be continued safely till term.

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The learning objectives of this modules are as follows:

y Appreciate the importance of patient education in GDM

y Learn about the monitoring protocol in GDM, with specific reference to SMBG

y Discuss the obstetric monitoring of a pregnant diabetic patient

y Learn the management of diabetes during labour and delivery

y Appreciate the importance of postpartum classification of glycemic status in the woman with GDM

To achieve these objectives, the day’s discussions are organized as follows:

y Pre-test

y Lecture 1: Monitoring of diabetes in pregnancy

y Lecture 2: Obstetric management

y Lecture 3: Follow up care and long term considerations in GDM

y Post-test

Pre-test(This will also serve as post-test after the day’s session)

Choose the most appropriate answer

1. Which of the following is the most appropriate method of monitoring glycemic control in pregnancy?A. Glycated hemoglobin (HbA1c)B. FructosamineC. Continuous Glucose Monitoring (CGM)D. Self Monitoring of Blood Glucose (SMBG)

2. Regarding HbA1c in pregnancy, all the following are true exceptA. It is often spuriously reduced in pregnancy secondary to iron deficiency anemiaB. It is useful in early pregnancy to differentiate GDM from pre-existing diabetesC. It may help in predicting the risk of congenital malformationsD. It may serve as a predictor of adverse maternal outcome

Module IV Management of Diabetes in Pregnancy - Part II

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3. Which of the following fetal biometric markers can be used to assess adequacy of glycemic control in the mother?A. Abdominal circumference (AC)B. Biparietal diameter (BPD)C. Femoral length (FL)D. Head circumference (HC)

4. All the following agents can be used to treat hypertension in pregnancy exceptA. NifedipineB. Labetalol

C. Methyldopa

D. Enalapril

5. Insulin requirements during pregnancy continue to increase until around ___A. 20 weeksB. 28 weeksC. 36 weeksD. 40 weeks

6. In patients on insulin, delivery is best carried out at ___A. 36 weeksB. 37 weeksC. 38 weeksD. 40 weeks

7. All women with GDM should undergo OGTT ___ after delivery to reassess glycemic status.A. 2 weeksB. 6 weeksC. 10 weeksD. 12 weeks

8. Which of the following is a risk factor for development of type 2 diabetes after GDM?A. ObesityB. Family history of diabetesC. Need for insulin during pregnancyD. All of the above

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9. Which is the contraceptive method of choice for a woman with poorly controlled type 1 diabetes?A. Combined OCPB. Progesterone only pillC. Depot medroxy progesterone D. IUCD

10. Regarding intrapartum management of hyperglycemia, all the following statements are true exceptA. Most women with GDM will not require insulin during deliveryB. In women with insulin requiring type 2 or type 1 diabetes, the subcutaneous long acting insulin

should be continued throughout labourC. Intravenous insulin infusion is the best mode of insulin delivery during labourD. CSII pump is another valuable therapeutic option

Answer Key: 1- D, 2- A, 3- A, 4- D, 5- C,

6- C, 7- B, 8- D, 9- D, 10- B

Module IV: Deals with monitoring, obstetric management and postpartum follow upThis final Module deals with monitoring, obstetric management and postpartum followup of a woman with GDM (and diabetes complicating pregnancy).

The role of SMBG in management of diabetes in pregnancy needs special emphasis here. It should be repeatedly stressed that the usual markers of glycemic control, such as HbA1c, are relatively unreliable during pregnancy. Hence regular monitoring of blood glucose by the patient at home is the only way to be sure if things are going as planned. Unfortunately, glucose meters and test strips are expensive in India; the frequency and timing of testing needs to be optimized to obtain the maximum benefit as well as cost-effectiveness. The role of fetal abdominal circumference (AC) as a marker of maternal diabetes control has recently received wide attention and must be alluded to here.

The second part of the Module deals with the obstetric management of the woman with diabetes. The points to be looked for during each antenatal visit as well as ultrasound exams are mentioned in detail.

Emphasize to the trainees that diabetes per se is not an indication for Caesarean section, although many women with diabetes will eventually end up having one, owing to other obstetric indications. Also explain the challenge of timing the delivery right.

Another important message is the necessity of assessing the glycemic status of the woman with GDM after delivery. Many patients drop off the diabetologist’s radar at this stage, presenting years later with uncontrolled diabetes or even with complications. Good communication between the obstetric unit and the primary physician can prevent most of these instances.

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Case StudiesCase Study 1 to 4

Case studies 1 to 4 emphasize the importance of monitoring fetal growth using growth charts as a surrogate of maternal glycemic control. The first three cases show disproportionate acceleration in abdominal circumference, indicating need for tighter control whereas the lady in Case 4 shows fetal growth restriction, perhaps indicating too-tight control of diabetes.

Case Study 5Mrs. E has GDM and is on 8 units of NPH insulin at bedtime in addition to 6 units of rapid acting insulin before breakfast. She complains of excess hunger during the early hours of the morning.

Her reports are as follows. Fasting After BF Before

lunchAfter lunch

Before dinner

After dinner

3 a.m.

Blood glucose (mg/dl) 61 102 90 112 91 107 58

• Are these values acceptable?

• What is the next line of treatment?

The patient’s fasting sugar levels are unacceptably low. The bedtime dose of insulin needs to be reduced.

Case Study 6Mrs. K has GDM and is on 10 units of NPH insulin at bedtime in addition to 8 units of rapid acting insulin before breakfast. She is compliant with the diet and exercise prescription

Her reports are as follows.Fasting After BF Before

lunchAfter lunch

Before dinner

After dinner

3 a.m.

Blood glucose (mg/dl) 88 115 95 162 100 105 79

• Are these values acceptable?

• What is the next line of treatment?

The patient’s after lunch values are high. One can consider adding a small dose of rapid acting or regular insulin at lunchtime.

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Case Study 7Mrs. R has GDM and is on 14 units of NPH insulin at bedtime in addition to 12 units of rapid acting insulin before breakfast.

Her reports are as follows.Fasting After BF Before

lunchAfter lunch

Before dinner

After dinner

3 a.m.

Blood glucose (mg/dl) 86 91 62 100 81 101 81

• Are these values acceptable?

• What is the next line of treatment?

The patient’s before-lunch readings are low. The morning dose of insulin can be reduced. Alternatively, she can be instructed to consume a regular mid-morning snack.

Case Study 8 (A)A 30 year old second gravida with type 1 diabetes of 12 years’ duration, presents to the emergency room during the 36th week of gestation with complaints of persistent vomiting and diminished fetal movements.

She admits skipping her last two doses of insulin due to vomiting and poor oral intake.

She has been irregular with her antenatal visits and her sugars have been unsatisfactory all through the pregnancy.

On examination, she is tachypneic, hyperventilating, tachycardic and dehydrated. Fetal heart sounds were absent. There were no obvious foci of infection.

• What is the most likely diagnosis?

• What investigations would be helpful?

Case Study 8 (B)Her blood reports are as follows:

Random plasma glucose=246 mg/dlSodium=142 mEq/lPotassium=3.3 mEq/lChloride=100 mEq/lBicarbonate=10 mEq/lUrea=61 mg/dlCreatinine=1.3 mg/dlArterial pH=7.1Urine ketones=++++

• What is the diagnosis?

• How would you manage this case?

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This case introduces the concept of diabetic ketoacidosis in pregnancy. The points to be noted are that the condition can occur at much lower plasma glucose levels in pregnancy than in the non-pregnant state and that the prognosis for the mother and fetus are poor.

Case Study 9Mrs. C is a 33 year old lady with type 2 diabetes of 4 years’ duration.

She has had hypertension for 3 years and is well-controlled on Tab. Telmisartan and Tab. Amlodipine.

She is now planning to conceive.

• What changes would you make to her medications?

• What should you look out for during pregnancy?

• What are the blood pressure targets for her?

Utilise this case study to discuss the management of hypertension in pregnancy. Obviously, in this case, telmisartan will have to be stopped.

Case Study 10A 33 year old lady (G4P3 A1) with GDM presents to the labour room at week 28 of gestation with preterm labour. She had GDM during her three previous pregnancies as well.

• Whatisthesignificanceofherhistory?

• What is the status of her fetus at 28 weeks and what are its chances of survival if delivered at this point?

This case scenario deals with a lady who has presented with preterm labor at 28 weeks. Utilise this scenario to discuss the topics of fetal maturity in GDM and timing of delivery.

Case Study 11 (A)Mrs. A aged 42 years was found to have GDM at 18 weeks of gestation and advised insulin. However she did not comply with advice and a scan around 30 weeks showed AC on 95th centile and AFI 20.Cervix is 1.5cm long and 2 cm dilated.

How would you manage this lady?

This lady needs to be hospitalized and her glycemic status stabilized. Steroids are also indicated for accelerating fetal lung maturation. There is no role for cerclage or indomethacin. Micronised progesterone (200 mg OD) can also be considered.

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Case Study 11 (B)She gets discharged against medical advice and comes back with a scan report at 35 weeks with AC on 95th centile and AFI 24. Cervix is 3 cm dilated, 1 cm long.

• When would you like to deliver her?

• How would you prepare for labour?

• What postnatal advice would you like to give?

In this situation, admission should be advised. If admitted with good control of BS, deliver by 37-38 weeks can be planned. One can consider keeping her in hospital till delivery because of history of poor compliance.

If the patient refuses admission, counselling regarding risks of premature delivery and IUFD should be given. Refusal of admission should be recorded and signed by the patient for medicolegal purposes. Micronised Progesterone can be considered while the role of rescue steroids is controversial. OPD review in 3 days can be offered, with advice to get admitted if any symptoms or signs of labour occur. Glycemic control should be re-emphasized.

Continuous fetal monitoring is essential. Cesarean section should be offered only if there are obstetric indications. The neonatologist should be at hand if the patients goes into labor prior to 37 weeks of gestation. Insulin and blood glucose monitoring should continue as per protocol (as discussed in the module).

Post-delivery, blood glucose should be estimated frequently in order to ensure that the sugars have returned to normal. Counselling regarding breastfeeding, diet and exercise and contraception should be given. The woman should be advised to return for an oral glucose tolerance test 6 weeks after delivery to confirm resolution of GDM.

Case Study 12 (A)A 33 year old lady presents in the 38th week of gestation. She has had three prior uncomplicated vaginal deliveries. The estimated fetal weight at this time is 4,600 g.

How would you counsel her about delivery?

Case Study 12 (B)After extensive counseling, the couple decline elective cesarean section delivery.

How should she be managed at this point in time?

This case focuses on the options for mode of delivery in GDM and diabetes complicating pregnancy. Even though the estimated fetal weight in this case is quite high, a trial of vaginal delivery can still be offered, provided adequate precautions are taken. Diabetes per se is not an indication for Cesarean section.

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Case Study 13Mrs. K, a 34 year old 2nd gravida, was found to have GDM at 27 week’s gestation and was put on insulin.

Following delivery, blood glucose levels normalised and she was able to stop insulin.

After 6 weeks, she underwent an OGTT with 75 g glucose, the results of which are as follows.Time 0 hour (Fasting) 2 hours

Glucose (mg/dl) 82 127

• What is the diagnosis?

• What is her risk of developing diabetes in the future?

• When should she be tested next?

This lady has normal glucose tolerance.

However, her risk of developing diabetes in the future is high and she needs to be tested annually with OGTT.

Case Study 14A 40 year old lady has a fasting blood glucose value of 154 mg/dl on her annual checkup.

She gives history of GDM during her 2nd pregnancy 6 years ago, following which she was delivered of a healthy 4.2 kg baby by Caesarean section.

She has not checked her blood glucose levels since until the present visit.

• What is the diagnosis?

• What is the next step?

This case study emphasizes one of the major problems in treating GDM i.e., loss of patients to follow-up after delivery. The lady in this case has most likely developed diabetes (although this has to be confirmed by repeat testing, preferably with an OGTT). We are unable to find out from the history as to whether her condition represents continuation of diabetes occurring in pregnancy or whether diabetes disappeared post-delivery only to recur after a certain time interval. As such, no estimate can be made as to the duration of diabetes. The lady therefore also needs to be screened for complications of diabetes such as nephropathy and retinopathy.

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Assignment 1 (to be submitted during Module III)

Compare and contrast the various criteria for the diagnosis of GDM. Which of these do you think is the most ideal one for your practice?

Assignment 2 (to be submitted during Module IV)

Describe how you would monitor and manage a 24 year old primigravida with GDM, who has failed to reach glycemic goal after two weeks of lifestyle modification.

AssessmentsThe content and curriculum of Certificate Course in Gestational Diabetes Mellitus– Cycle I has evolved through a dynamic quality assurance process which includes continuous revisions of the curriculum, peer reviews and benchmarking. The course is delivered on modular basis and each module has specific learning objectives. They are achieved through application of certain pedagogical tools which include lectures, case-studies, assignments and group discussion.

Quality Assurance of the course is maintained through:

(1) Documentation of the design, development, delivery and impact of the curriculum,(2) Evaluation of the trainees by the faculty and(3) Collection of feedback from the trainees.

Evaluation of the trainees includes the assessment by the faculty which covers the traditional academic aspects of internal assessment and evaluation. However, it also has a component of personalized mentoring to address the weaknesses in the trainees through a tailored approach. The evaluation of the trainees by the faculty includes:

y Monitoring of acquisition of the core competencies

y Identification of weaknesses for specific support

y Internal assessment

Collection of feedback from the trainees includes ongoing monitoring of the learning activities using scoring sheets (e.g., pre-test & post-tests during each session) and regular qualitative discussions that identify key issues to be addressed. The purpose of the assessments is to:

y Help regional faculty to identify participant’s needs and adjust instructions to improve learning.

y Help regional faculty to document whether participants are learning what they are expected to learn

Appendix

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y Provide indication to participants on topics/skills which should be concentrated upon.

y Provide valuable guidance and objective criteria for award of certificate to the participants on the basis of their performance

The following Matrix briefly outlines the instruments and their purpose for participant’s assessment. The matrix is simple yet robust keeping in view the learning objectives and pedagogical tools.

Matrix for Assessment Instrument What Measured When Measured

Pre-test and Post-testKnowledge Tests

Is learning taking place, and to what extent?• Knowledge of participants• Teaching of content

Pre-Training

Post-Training

AssignmentsClinical Practice improvement• Adherence to evidence based guidelines

Assignment 1(Module III)

Assignment 2(Module IV)

Overall attendanceCommitment to continuing education• Maintaining peer network of evidence based practice

After completion of all modules

Award of CertificateCertificate of Successful Completion

y Participation in all the 4 monthly contact session (including the pre-test and post-test of each module)

y Completion of assigned course work (Two descriptive assignments based on completed modules given at end of IIIrd and IVth module)

y Appearance and clearance of final written examination in the form of MCQ’s in an hour, along with Module IV (minimum of 50% score to clear the examination)

Note: Once the participant complete all the above mentioned criteria’s only then, he/she will be considered for certification which will be jointly issued by PHFI, DMDEA and respective Regional Faculty after the completion of the course

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Assessment Sheet

Name of Regional Centre: .................................................................................................... Date: .....................................

Name of Regional Faculty 1 : ............................................................................................... Module No. : ....................

Name of Regional Faculty 2 : ................................................................................................

Module Name: ..............................................................................................................................................................................

S.No Name of Participants

Attendance(Yes/No)

Pre-test score

Post-testscore

Improvement(Post - Pre)

Assignment Submitted(Yes/No)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Signature

Faculty 1

Signature

Faculty 2

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Reporting MatricesFeedbacks are cornerstone to any successful program. They provide an opportunity to learn from good performing centres and at the same time highlight the issues that require immediate attention. The following reporting matrix captures all the components related to assessment of participants at a regional centre succinctly. It is a valuable tool to monitor progress of an individual participant also.

Sample: Reporting Matrix for every session from a regional centre

Name of Participant

AttendancePre-test

scorePost-test

scoreImprovement

(Post-Pre)Assignment

submission on time

Participant x

Participant y

Participant z

Sample: Reporting Matrix for Participant X for complete course

Module Number

Attendance( Overall )

Pre-test score

( Overall )

Post-test score

( Overall )

Improvement(Post-Pre)( Overall )

Assignments( Overall )

Exit Exam

Module I P 5 10 5 NA Exit exam will be

conducted along with Module IV,

minimum of 50% passing

score is mandatory

Module II P 5 10 5 NA

Module III P 5 10 5Yes

(Assignment 1)

Module IV P 5 10 5Yes

(Assignment 2)

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Personalized feedback

A rubric is a scoring tool for assessments. It is a set of criteria and standards linked to learning objectives that is used to assess performance on papers, essays, and other assignments. Rubrics allow for standardized evaluation according to specified criteria, making grading simpler and more transparent.

Following set of Rubrics are developed to make the assessment criteria objective and to facilitate personalized feedback to participants.

Rubric for assessment for Clinical Case Sheets/Interim Assignments

Poor Good Excellent

Clinical History

History is poor atinformation andvaguely written.

History sometimesis rambling anddisjointed.

History is relevantand informativebut misses keyinformation. It could be more elaborateand comprehensive.

History is relevant andinformative. Provideclear, coherent &concise informationregarding diseasedevelopment.

Diagnosis

Differential diagnosisis insufficient,inaccurate, orincomplete, wrongdiagnosis

Differential diagnosisis complete andaccurate butcould improveunderstandingnuance of the case.

Differential diagnosisis textbook Levelcomplete, clear,concise, prioritized, &correct, faculty level

Management

Disease managementis insufficient,incomplete, orinappropriate. Noguidelines followed.

Complete, adequatedisease management,simple butappropriate.

Some understandingof nuances.

Comprehensivedisease managementplan that includesunderstanding of nextsteps. Prioritizes carefor prevention andrehabilitation also.

Note: These grades are not required at the Secretariat, they are meant for providing individualized feedback to the participant and guidance to faculty for mentorship.

These Rubrics are meant for evaluation of clinical assignment and case sheets under certain parameter only, however the faculty may wish to add more parameters, still the final outcome should remain between Poor, Good and Excellent grades. They provide guidance to evaluate participants existing knowledge base, its application to patient care and finally the motivation to successfully complete and submit the assignment.

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Notes:

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