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Service Line: Rapid Response Service
Version: 1.0
Publication Date: December 21, 2018
Report Length: 15 Pages
CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS
Continuous Glucose Monitoring for Patients with All Diabetes Types: Clinical Effectiveness and Guidelines
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 2
Authors: Deba Hafizi, Monika Mierzwinski-Urban
Cite As: Continuous Glucose Monitoring for Patients with All Diabetes Types: Clinical Effectiveness and Guidelines. Ottawa: CADTH; Dec 2018. (CADTH rapid
response report: summary of abstracts).
Acknowledgments:
Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders,
and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document,
the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular
purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical
judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and
Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.
While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date
the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the
quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing
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has no responsibility for the collection, use, and disclosure of personal information by third-party sites.
Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canadas federal,
provincial, or territorial governments or any third party supplier of information.
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About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canadas health care decision-makers with objective evidence
to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system.
Funding: CADTH receives funding from Canadas federal, provincial, and territorial governments, with the exception of Quebec.
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 3
Research Questions
1. What is the clinical effectiveness of continuous glucose monitoring for patients with any
type of diabetes?
2. What are the evidence-based guidelines associated with continuous glucose monitoring
for patients with any type of diabetes?
Key Findings
Three health technology assessments and sixteen randomized control trials were identified
regarding the clinical effectiveness of continuous glucose monitoring systems for patient
with any type of diabetes. In addition, nine evidence-based guidelines associated with
continuous glucose monitoring for patients with any type of diabetes were identified.
Methods
A limited literature search was conducted on key resources including PubMed, the
Cochrane Library, University of York Centre for Reviews and Dissemination (CRD)
databases, Canadian and major international health technology agencies, as well as a
focused Internet search. Methodological filters were applied to limit retrieval to health
technology assessments, systematic reviews, meta-analyses, guidelines and randomized
controlled trials. The search was also limited to English language documents published
between January 1, 2013 and November 29, 2018. Internet links were provided, where
available.
Selection Criteria
One reviewer screened citations and selected studies based on the inclusion criteria
presented in Table 1.
Table 1: Selection Criteria
Population Patients with Type I, Type II, or gestational diabetes mellitus Pediatric population (
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 4
Results
Rapid Response reports are organized so that the higher quality evidence is presented first.
Therefore, health technology assessment reports, systematic reviews, and meta-analyses
are presented first. These are followed by randomized controlled trials and evidence-based
guidelines.
Three health technology assessments and sixteen randomized control trials were identified
regarding the clinical effectiveness of continuous glucose monitoring systems for patient
with any type of diabetes. In addition, nine evidence-based guidelines associated with
continuous glucose monitoring for patients with any type of diabetes were identified. No
relevant systematic reviews or meta-analyses were identified.
Additional references of potential interest are provided in the appendix.
Overall Summary of Findings
Three health technology assessments (HTAs)1-3 and sixteen randomized control trials
(RCTs) 4-19 were identified regarding the clinical effectiveness of continuous glucose
monitoring (CGM) systems for patient with any type of diabetes. Detailed study
characteristics are provided in Table 2.
Each HTA examined the safety and clinical effectiveness of various insulin pumps with
continuous glucose monitoring, some of which included an algorithm to suspend and restart
insulin delivery.2-3 The National Institute of Health and Care Excellence (NICE) observed
that the Space Glucose Control System was safe and effective in controlling blood glucose
in intensive care unit settings for critically ill patients with diabetes.1 An HTA by the Swedish
Council on Health Technology observed that consumers were more satisfied with sensor-
augmented pumps (SAP).2 The authors of another HTA3, observed that SAPs are
significantly favoured over multiple daily injections (MDI) and the best SAP on the market
for reducing hypoglycemic events is the Medtronic MiniMed Paradigm Veo system.3
Each of the RCTs either directly4,6,9,10,13-15,17,18 or indirectly5,7,11,12,16 examined the clinical
effectiveness of insulin pumps with CGM to improve glycemic control, reduce hypoglycemic
events, and/or consumer satisfaction in patients with either Type 1 Diabetes Mellitus (TIDM)
or Type 2 Diabetes Mellitus (TIIDM) in adult and pediatric populations. A few studies also
examined the ability of insulin pumps with CGM to detect or predict the frequency of
morning ketosis18 or in preserving beta cells in newly diagnosed patients with TIDM15 In
general, authors examining SAPs reported them to be safe and effective; however, artificial
pancreas systems were found to be superior to SAP in the management of hypoglycemia in
diabetes.5-8,11,12,16
Nine evidence-based guidelines associated with continuous glucose monitoring for patients
with any type of diabetes were identified. Detailed recommendations can be found in Table
3.
Guidelines from Health Quality Ontario recommend that CGM be publicly funded for
patients with TIDM who are willing to use CGM the majority of the time and who also meet
specific criteria. Another two guidelines from NICE21,22 also recommend CGM for children
and young people with TIDM that have severe hypoglycemic events, or cannot recognize
hypoglycemic events or communicate about the symptoms of hypoglycaemia.21 They
further recommend the Medtronic MiniMed Paradigm Veo system (SAP) as a feasible
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 5
option for managing blood glucose levels in patients with TIDM that have episodes of
disabling hypoglycemia despite optimal management with continuous subcutaneous insulin
infusion.22
Guidelines from Italy for pediatric patients with TIDM 23 recommend that the national health
services provide necessary resources such as CGM according to standards of care.
Guidelines for pediatric TIDM patients24 recommend CGM use for patients with HbA1c
levels 7% and able to use it on a nearly daily basis. There were no recommendations for
or against CGM for patients below the age of eight.24 Guidelines for adults with TIDM 24-25
recommend real-time CGM devices for adult patients who have A1C levels above target as
well as with well-controlled patients who are willing and able to use these devices on a
nearly daily basis. For adults with TIIDM, the guidelines25 suggest that real-time CGM be
used in a short-term and intermittent basis for patients with A1C levels 7% and that are
willing and able to use the device. Additionally the authors of these guidelines25 suggest
that adults with TIDM and TIIDM who use insulin pumps and CGM receive education,
training, and ongoing support to help achieve and maintain individualized glycemic goals.
The Canadian Diabetes Association guidelines27 recommends that people with TIDM use
real-time CGM to improve glycemic control. Lastly, the Standards of Medical Care in
Diabetes recommends SAP with low glucose threshold suspend systems be considered for
patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness.28
One of the identified guidelines did not mention any specific recommendations within their
abstract.26
Table 2: Summary of Included Studies on Continuous Glucose Monitoring for Patients with All Diabetes Types
First Author,
Year
Study Characteristics
Interventions Comparators Outcomes Conclusions
Health Technology Assessments Type 1 Diabetes Mellitus
NICE 20141 Two studies included
Intensive care unit
Space GlucoseControl
None Glycemic control
Safety
Safe and effective controlling blood glucose
Swedish Council on Health Technology 20132
NR CGM SAP
None Consumer satisfaction
Clinical effectiveness
Cost-effectiveness
Consumers are most satisfied with SAP than with modern therapy
SAP improves HbA1c
Higher cost associated with CGM than strips
Riemsma 20163
19 studies, 54 publications included
CGM-pump systems:
MiniMed Paradigm Veo;
Vibe
MDI
Insulin pump with or without CGM
Glycemic control
Hypoglycemic events
SAPs significantly favoured over MDI for blood glucose control and QOL
Veo system best at reducing hypoglycemic
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 6
First Author,
Year
Study Characteristics
Interventions Comparators Outcomes Conclusions
events
Randomized Controlled Trials Type 1 Diabetes Mellitus
Breton 20184
Adult population
N= 24
48-h visits
SAP (Dexcom G4)
Usual care insulin pump or daily injections
Glycemic Control
Improved blood glucose control and reduced hypoglycemic events safely
Ruan 20185 Adult population
N=60
Crossover design
CLC Conventional insulin pump
SAP
Nocturnal hypoglycemic events
Significantly lower risk of hypoglycemic events using CLC versus conventional pump or SAP therapy
Brown 2017 6
Adult population
N=44
SAP CLC Glycemic control
Overnight CLC was more successful in reaching glycemic targets
El-Khatib 20177
Adult population
N=43
Study length 11 days
Crossover design
AP (Bihormonal bionic pancreas)
Insulin pumps and SAP
Glycemic control
Bihormonal bionic pancreas was more successful in achieving superior glycemic regulation
Kropff 20158 Adult population
N= NR
Crossover design
Study length 2 months
AP + SAP SAP only Glycemic control
Percent time in target glucose range
The mean time spent in the target range was higher with AP than with SAP use8
AP decreased HbA1C levels significantly greater than control
Buckingham 20139
Adult population
N=19
Pilot study
Study length 21 nights
PLGS system: MiniMed Paradigm active
Inactive system Safety
Nocturnal hypoglycemic events
Safe and feasible
Overnight hypoglycemia was lower on intervention than control nights.9
Forlenza 201810
Pediatric population
N=28
PHHM insulin pump system
PLGS insulin pump System
Safety
Glycemic control
PHHM was more effective in improving overnight glycemic control and decreasing glycemic variability compared to PLGS
Renard 201811
Pediatric population
N=24
Hotel setting
Study length 48-h
CLC SAP (Threshold-low-glucose-suspend insulin pump)
Glycemic control
Nocturnal hypoglycemic events
Target glucose ranges were similar for both over a 48-h period
CLC did not minimize overnight hypoglycemic event but improved time in target range11 compared to control
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 7
First Author,
Year
Study Characteristics
Interventions Comparators Outcomes Conclusions
Tauschmann 201812
Pediatric population
N=86
CLC SAP Glycemic control
Hypoglycemic events
CLC achieved target glycemic ranges significantly more than SAP therapy
CLC reduced risk of hypoglycemic event
Anderson 201613
Pediatric population
N=22
Cross over design
SAP (PumpTune; uses an algorithm)
Clinician recommendations
Glycemic control
Hypoglycemic events
PumpTune was superior in achieving glycemic target range compared to clinician settings
Buckingham 201514
Pediatric population
N=86
Study length 42 nights
PLGS system Inactive system Percent time below glycemic threshold 70mg/dL
Ketosis
PLGS substantially reduced overnight hypoglycemia
No difference in morning blood ketosis
Buckingham 201315
Pediatric population
N=68
CLC + SAP therapy
MDI or insulin pump therapy
Beta-cell preservation (C-peptide concentration during mixed-meal tolerance tests)
In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving beta-cell function compared with current standards of care.15
Sharifi 201616
Mixed population (15 adults and 12 youth)
N=28
Crossover design
CLC SAP with low-glucose suspend
Glycemic control
Nocturnal hypoglycemic events
Consumer satisfaction
CLC in both adults and adolescents reduced nocturnal hypoglycemia and, in adults, improved overnight time in target range and treatment satisfaction compared with SAP.16
Calhoun 201617
Mixed ages
N=127
Study length 2 months
PLGS system None Glycemic control
Nocturnal hypoglycemic events
The PLGS system was effective in preventing hypoglycemia for each factor subgroup.17
No difference in nocturnal hypoglycemic events
Beck 201418 N=45
Mixed population (15 adults and 12 youth)
Crossover design
PLGS system None Frequency of morning ketosis
Use of PLGS not a good predictor of blood or urine ketones; routine measurement with CGM not necessary
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 8
First Author,
Year
Study Characteristics
Interventions Comparators Outcomes Conclusions
Randomized Controlled Trials Type 2 Diabetes Mellitus
Gu 201719 N=81
Adult population
Single blinded
Study length 2 weeks
SAP (MiniMed Paradigm 722 system)
MDI with blinded CGM (MiniMed CGMS System Gold)
Glycemic control
Nocturnal hypoglycemic events
SAP vs MDI therapy in hospitalized patients with T2DM significantly reduced the time required to achieve glycaemic targets
AP=artificial pancreas; CGM = continuous glucose monitoring; CLC = closed loop control pump system; MDI = multiple daily injections; NICE=national institute of health and care excellent; NR = not reported; SAP = sensor-augmented pump which includes CGM and insulin pump; PLGS = predictive low-glucose suspend system; PHHM = predictive hyperglycemia and hypoglycemia minimization system; QOL= quality of life; SAP = sensor-augmented pumps.
Table 3: Summary of Recommendations in Included Guidelines
Author Year Recommendationsa
Type 1 Diabetes Mellitus Mixed - Adult and Pediatric Populations
Health Quality Ontario 201820
Recommends publicly funding continuous glucose monitoring in patients with type 1 diabetes who are willing to use continuous glucose monitoring for the vast majority of the time20 and who also meet the
following criteria:
An inability to recognize or communicate symptoms of hypoglycemia or
Exhibit severe hypoglycemia despite optimized use of insulin therapy and conventional blood glucose monitoring
NICE 201621 Recommends that continuous glucose monitoring is not routinely offered and should only be considered when standard management of blood glucose levels has not worked or been difficult. However, the NICE guideline for children and young people with type 1 diabetes recommends that children and young people who have severe hypoglycaemic events, or cannot recognise hypoglycaemic events or communicate about the symptoms of hypoglycaemia, should be offered continuous glucose monitoring.21
NICE 201622 NICE diagnostics guidance on integrated sensor-augmented pump therapy systems recommends the MiniMed Paradigm Veo in selected patients and in specific circumstances 1.1 The MiniMed Paradigm Veo system is recommended as an option for managing blood glucose levels in people with type 1 diabetes only if:
- they have episodes of disabling hypoglycaemia despite optimal management with continuous subcutaneous insulin infusion and
- the company arranges to collect, analyse and publish data on the use of the MiniMed Paradigm Veo system22
1.2 The MiniMed Paradigm Veo system should be used under the supervision of a trained multidisciplinary team who are experienced in continuous subcutaneous insulin infusion and continuous glucose monitoring for managing type 1 diabetes only if the person or their carer:
- agrees to use the sensors for at least 70% of the time, - understands how to use it and is physically able to use the system and - agrees to use the system while having a structured education programme on diet and lifestyle,
and counselling.22
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 9
Table 3: Summary of Recommendations in Included Guidelines
Author Year Recommendationsa
Type 1 Diabetes Mellitus Pediatric Population
Scaramuzza 201423
Recommends that the Italian National Health Service should provide all necessary resources to ensure self-monitoring of blood glucose and possibly continuous glucose monitoring of all children and adolescents with type 1 diabetes, according to the standards of care provided by these recommendations and internationally.23
Type 1 and 2 Diabetes Mellitus Adult and Pediatric Populations
Peters 201824 2.1 We recommend that RT-CGM with currently approved devices be used by children and adolescents with T1DM who have achieved glycosylated hemoglobin (HbA1c) levels below 7.0% because it will assist in maintaining target HbA1c levels while limiting the risk of hypoglycemia.24
2.2 We recommend RT-CGM devices be used with children and adolescents with T1DM who have HbA1c levels 7.0% who are able to use these devices on a nearly daily basis.24
2.3 We make no recommendations for or against the use of RT-CGM by children with T1DM who are less than 8 years of age24
In addition, same recommendations mentioned below, Peters 201625
Peters 201625 6.1 We recommend real-time continuous glucose monitoring (RT-CGM) devices for adult patients with T1DM who have A1C levels above target as well as with well-controlled T1DM and who are willing and able to use these devices on a nearly daily basis.25 6.3 We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels 7% and are willing and able to use the device.25 6.4 We suggest that adults with T1DM and T2DM who use CSII and CGM receive education, training, and ongoing support to help achieve and maintain individualized glycemic goals. (Ungraded Good Practice Statement)25
Type I and Type II Diabetes Unspecified Ages
Kesavadev 201426 No specific recommendations available in abstract
Canadian Diabetes Association 201627
In people with type 1 diabetes, real-time continuous glucose monitoring may be used to improve glycemic control [Grade B, Level 2 (58)] and reduce hypoglycemia [Grade B, Level 2 (65,69)].27
Standards of Medical Care in Diabetes 201528
For patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness, a sensor-augmented low glucose threshold suspend pump may be considered.28
NICE=National Institute of Health and Care Excellence; T1DM=type 1 diabetes mellitus; T2DM= type 2 diabetes mellitus.
a Verbatim recommendations.
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 10
References Summarized
Health Technology Assessments
Type 1 Diabetes
Adult Population
1. National Institute for Health and Care Excellence. The Space GlucoseControl system
for managing blood-glucose in critically ill patients in intensive care. (NICE Medtech
innovation briefing MIB17). London (GB): NICE; 2014:
https://www.nice.org.uk/advice/mib17/resources/the-space-glucosecontrol-system-for-
managing-bloodglucose-in-critically-ill-patients-in-intensive-care-pdf-63498989701573.
Accessed 2018 Dec 20
Mixed Population or Age Unspecified
2. Swedish Council on Health Technology Assessment. Continuous subcutaneous
glucose monitoring for diabetes. 2013; https://www.sbu.se/201304e. Accessed 2018
Dec 20.
PubMed: PM26803872
3. Riemsma R, Corro Ramos I, Birnie R, et al. Integrated sensor-augmented pump therapy
systems [the MiniMed(R) Paradigm Veo system and the Vibe and G4(R) PLATINUM
CGM (continuous glucose monitoring) system] for managing blood glucose levels in
type 1 diabetes: a systematic review and economic evaluation. Health Technol Assess.
2016 Feb;20(17):v-xxxi, 1-251.
PubMed: PM26933827
Systematic Reviews and Meta-analyses
No literature identified.
Randomized Controlled Trials
Type 1 Diabetes
Adult Population
4. Breton MD, Patek SD, Lv D, et al. Continuous glucose monitoring and insulin informed
advisory system with automated titration and dosing of insulin reduces glucose
variability in type 1 diabetes mellitus. Diabetes Technol Ther. 2018 Aug;20(8):531-540
PubMed: PM29979618
5. Ruan Y, Bally L, Thabit H, et al. Hypoglycaemia incidence and recovery during home
use of hybrid closed-loop insulin delivery in adults with type 1 diabetes. Diabetes Obes
Metab. 2018 Aug;20(8):2004-2008.
PubMed: PM29577536
6. Brown SA, Breton MD, Anderson SM, et al. Overnight closed-loop control improves
glycemic control in a multicenter study of adults with type 1 diabetes. J Clin Endocrinol
Metab. 2017 Oct 1;102(10):3674-3682.
PubMed: PM28666360
https://www.nice.org.uk/advice/mib17/resources/the-space-glucosecontrol-system-for-managing-bloodglucose-in-critically-ill-patients-in-intensive-care-pdf-63498989701573https://www.nice.org.uk/advice/mib17/resources/the-space-glucosecontrol-system-for-managing-bloodglucose-in-critically-ill-patients-in-intensive-care-pdf-63498989701573https://www.sbu.se/201304ehttp://www.ncbi.nlm.nih.gov/pubmed/26803872http://www.ncbi.nlm.nih.gov/pubmed/26933827http://www.ncbi.nlm.nih.gov/pubmed/29979618http://www.ncbi.nlm.nih.gov/pubmed/29577536http://www.ncbi.nlm.nih.gov/pubmed/28666360
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 11
7. El-Khatib FH, Balliro C, Hillard MA, et al. Home use of a bihormonal bionic pancreas
versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised
crossover trial. Lancet. 2017 Jan 28;389(10067):369-380.
PubMed: PM28007348
8. Kropff J, Del Favero S, Place J, et al. 2 month evening and night closed-loop glucose
control in patients with type 1 diabetes under free-living conditions: a randomised
crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-947.
PubMed: PM26432775
9. Buckingham BA, Cameron F, Calhoun P, et al. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-627. PubMed: PM23883408
Pediatric Population
10. Forlenza GP, Raghinaru D, Cameron F, et al. Predictive hyperglycemia and
hypoglycemia minimization: in-home double-blind randomized controlled evaluation in
children and young adolescents. Pediatr Diabetes. 2018 May;19(3):420-428.
PubMed: PM29159870
11. Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, et al. Closed-loop driven by control-
to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on
glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type
1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019 Jan;21(1):183-
187.
PubMed: PM30047223
12. Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally
controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet. 2018 Oct
13;392(10155):1321-1329.
PubMed: PM30292578
13. Anderson D, Phelan H, Jones K, et al. Evaluation of a novel continuous glucose
monitoring guided system for adjustment of insulin dosing - PumpTune: a randomized
controlled trial. Pediatr Diabetes. 2016 Nov;17(7):478-482.
PubMed: PM26701831
14. Buckingham BA, Raghinaru D, Cameron F, et al. Predictive low-glucose insulin
suspension reduces duration of nocturnal hypoglycemia in children without increasing
ketosis. Diabetes Care. 2015 Jul;38(7):1197-1204.
PubMed: PM26049549
15. Buckingham B, Beck RW, Ruedy KJ, et al. Effectiveness of early intensive therapy on
beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-4035.
PubMed: PM24130350
http://www.ncbi.nlm.nih.gov/pubmed/28007348http://www.ncbi.nlm.nih.gov/pubmed/26432775http://www.ncbi.nlm.nih.gov/pubmed/23883408http://www.ncbi.nlm.nih.gov/pubmed/29159870http://www.ncbi.nlm.nih.gov/pubmed/30047223http://www.ncbi.nlm.nih.gov/pubmed/30292578http://www.ncbi.nlm.nih.gov/pubmed/26701831http://www.ncbi.nlm.nih.gov/pubmed/26049549http://www.ncbi.nlm.nih.gov/pubmed/24130350
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 12
Mixed Population Adults and Pediatric Populations
16. Sharifi A, De Bock MI, Jayawardene D, et al. Glycemia, treatment satisfaction,
cognition, and sleep quality in adults and adolescents with type 1 diabetes when using a
closed-loop system overnight versus sensor-augmented pump with low-glucose
suspend function: a randomized crossover study. Diabetes Technol Ther. 2016
Dec;18(12):772-783.
PubMed: PM27835037
17. Calhoun PM, Buckingham BA, Maahs DM, et al. Efficacy of an overnight predictive low-
glucose suspend system in relation to hypoglycemia risk factors in youth and adults with
type 1 diabetes. J Diabetes Sci Technol. 2016 Nov;10(6):1216-1221.
PubMed: PM27207890
18. Beck RW, Raghinaru D, Wadwa RP, Chase HP, Maahs DM, Buckingham BA.
Frequency of morning ketosis after overnight insulin suspension using an automated
nocturnal predictive low glucose suspend system. Diabetes Care. 2014;37(5):1224-
1229.
PubMed: PM24757229
Type 2 Diabetes
Adult Population
19. Gu W, Liu Y, Chen Y, et al. Multicentre randomized controlled trial with sensor-
augmented pump vs multiple daily injections in hospitalized patients with type 2
diabetes in China: time to reach target glucose. Diabetes Metab. 2017 Sep;43(4):359-
363.
PubMed: PM28236571
Guidelines and Recommendations
Type I Diabetes
Mixed Population Adult and Pediatric Populations
20. Health Quality Ontario. Continuous monitoring of glucose for Type 1 diabetes: OHTAC
recommendation. (Final recommendation). Toronto (ON): HQO; 2018.
http://www.hqontario.ca/Portals/0/Documents/evidence/reports/recommendation-
continuous-monitoring-of-glucose-for-type-1-diabetes-en.pdf. Accessed 2018 Dec 20.
21. National Institute for Health and Care Excellence. MiniMed 640G system with
SmartGuard for managing blood glucose levels in people with type 1 diabetes. (NICE
Medtech innovation briefing MIB51). London (GB): NICE; 2016.
https://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-
smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-
63499221488581. Accessed 2018 Dec 20.
22. National Institute for Health and Care Excellence. Integrated sensor-augmented pump
therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed
Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). (NICE
diagnostics guidance DG21). London (GB): NICE; 2016.
https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-
therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-
http://www.ncbi.nlm.nih.gov/pubmed/27835037http://www.ncbi.nlm.nih.gov/pubmed/27207890http://www.ncbi.nlm.nih.gov/pubmed/24757229http://www.ncbi.nlm.nih.gov/pubmed/28236571http://www.hqontario.ca/Portals/0/Documents/evidence/reports/recommendation-continuous-monitoring-of-glucose-for-type-1-diabetes-en.pdfhttp://www.hqontario.ca/Portals/0/Documents/evidence/reports/recommendation-continuous-monitoring-of-glucose-for-type-1-diabetes-en.pdfhttps://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-63499221488581https://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-63499221488581https://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-63499221488581https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 13
paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221.
Accessed 2018 Dec 20.
Evidence:
https://www.nice.org.uk/guidance/dg21/evidence
Pediatric Population
23. Scaramuzza A, Cherubini V, Tumini S, et al. Recommendations for self-monitoring in
pediatric diabetes: a consensus statement by the ISPED. Acta Diabetol. 2014
Apr;51(2):173-184.
PubMed: PM24162715
Type I and Type II Diabetes
Adult Population
24. Peters AL, Ahmann AJ, Hirsch IB, Raymond JK. Advances in glucose monitoring and
automated insulin delivery: supplement to Endocrine Society clinical practice guidelines.
J Endocr Soc. 2018 Nov 1;2(11):1214-1225.
PubMed: PM30324178
25. Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology-continuous
subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an
Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016
Nov;101(11):3922-3937.
PubMed: PM27588440
Type I and Type II Diabetes
Unspecified Ages
26. Kesavadev J, Sadikot S, Wangnoo S, et al. Consensus guidelines for glycemic
monitoring in type 1/type 2 & GDM. Diabetes Metab Syndr. 2014 Jul-Sep;8(3):187-195.
PubMed: PM25200925
27. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and
management of diabetes in Canada. Can J Diabetes. 2013 Apr;37(Suppl 1).
http://guidelines.diabetes.ca/App_Themes/CDACPG/resources/cpg_2013_full_en.pdf,
Accessed 2018 Dec 20.
See: Recommendation 5, page S37
28. Standards of medical care in diabetes-2015. Diabetes Care. 2015;38(Suppl 1).
http://care.diabetesjournals.org/content/suppl/2014/12/23/38.Supplement_1.DC1/Januar
y_Supplement_Combined_Final.6-99.pdf. Accessed 2018 Dec 20.
See: Recommendation 4, page S41
https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221https://www.nice.org.uk/guidance/dg21/evidencehttp://www.ncbi.nlm.nih.gov/pubmed/24162715http://www.ncbi.nlm.nih.gov/pubmed/30324178http://www.ncbi.nlm.nih.gov/pubmed/27588440https://www.ncbi.nlm.nih.gov/pubmed/25200925https://www.ncbi.nlm.nih.gov/pubmed/25200925http://guidelines.diabetes.ca/App_Themes/CDACPG/resources/cpg_2013_full_en.pdfhttp://care.diabetesjournals.org/content/suppl/2014/12/23/38.Supplement_1.DC1/January_Supplement_Combined_Final.6-99.pdfhttp://care.diabetesjournals.org/content/suppl/2014/12/23/38.Supplement_1.DC1/January_Supplement_Combined_Final.6-99.pdf
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 14
Appendix Further Information
Previous CADTH Reports
29. A hybrid closed-loop insulin delivery system for the treatment of type 1 diabetes.
(CADTH issues in emerging helath technologies no. 155). Ottawa (ON): CADTH; 2017:
https://www.cadth.ca/sites/default/files/pdf/eh0052_hybrid_closed-
loop_insulin_delivery_system_for_the_treatment_of_type_1_diabetes.pdf. Accessed
2018 Dec 20.
30. Continuous glucose monitoring systems for pediatric patients with type 1 diabetes:
clinical and cost-effectiveness. (CADTH Rapid response report: summary of abstracts).
Ottawa (ON): CADTH; 2016:
https://www.cadth.ca/sites/default/files/pdf/htis/2016/RB1043%20CGM%20for%20Pedia
tric%20Patients%20Final.pdf. Accessed 2018 Dec 20.
31. Glucose meter use with insulin pumps: a clinical and cost effectiveness review. (CADTH
Health Technology Inquiry Service). Ottawa (ON): CADTH; 2008:
https://www.cadth.ca/sites/default/files/pdf/htis/Glucose%20Meter%20Use%20with%20I
nsulin%20Pumps%20A%20Clinical%20and%20Cost%20Effectiveness%20Review.pdf.
Accessed 2018 Dec 20.
Systematic Reviews and Meta-Analyses
Continuous Glucose Monitor and Insulin Pump Separate
32. Pavela J, Suresh R, Blue RS, Mathers CH, Belalcazar LM. Management of diabetes
during air travel: a systematic literature review of current recommendations and their
supporting evidence. Endocr Pract. 2018 Feb;24(2):205-219.
PubMed: PM29466062
Randomized Control Trials Aritificial Pancreas
Type I Diabetes
Mixed Population Adult and Pediatric Populations
33. Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic
pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325.
PubMed: PM24931572
Clinical Practice Guidelines Unspecified Methodology
Type 1 Diabetes
Adult Population
34. Choudhary P, Rickels MR, Senior PA, et al. Evidence-informed clinical practice
recommendations for treatment of type 1 diabetes complicated by problematic
hypoglycemia. Diabetes Care. 2015 Jun;38(6):1016-1029.
PubMed: PM25998294
https://www.cadth.ca/sites/default/files/pdf/eh0052_hybrid_closed-loop_insulin_delivery_system_for_the_treatment_of_type_1_diabetes.pdfhttps://www.cadth.ca/sites/default/files/pdf/eh0052_hybrid_closed-loop_insulin_delivery_system_for_the_treatment_of_type_1_diabetes.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/2016/RB1043%20CGM%20for%20Pediatric%20Patients%20Final.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/2016/RB1043%20CGM%20for%20Pediatric%20Patients%20Final.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/Glucose%20Meter%20Use%20with%20Insulin%20Pumps%20A%20Clinical%20and%20Cost%20Effectiveness%20Review.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/Glucose%20Meter%20Use%20with%20Insulin%20Pumps%20A%20Clinical%20and%20Cost%20Effectiveness%20Review.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/29466062http://www.ncbi.nlm.nih.gov/pubmed/24931572http://www.ncbi.nlm.nih.gov/pubmed/25998294
SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 15
Position Statements
35. Borot S, Benhamou PY, Atlan C, et al. Practical implementation, education and
interpretation guidelines for continuous glucose monitoring: a French position
statement. Diabetes Metab. 2018 Feb;44(1):61-72.
PubMed: PM29174479
36. Grunberger G, Handelsman Y, Bloomgarden ZT, et al. American Association of Clinical
Endocrinologists and American College of Endocrinology 2018 position statement on
integration of insulin pumps and continuous glucose monitoring in patients with diabetes
mellitus. Endocr Pract. 2018 Mar;24(3):302-308.
PubMed: PM29547046
37. Choudhary P, Rickels MR, Senior PA, et al. Evidence-informed clinical practice
recommendations for treatment of type 1 diabetes complicated by problematic
hypoglycemia. Diabetes Care. 2015 Jun;38(6):1016-1029.
PubMed: PM25998294
Protocols for Future Randomized Controlled Trials
Type I Diabetes
Adult Population
38. De Valk HW, Lablanche S, Bosi E, et al. Study of MiniMed 640G Insulin pump with
SmartGuard in prevention of low glucose events in adults with type 1 diabetes (SMILE):
design of a hypoglycemia prevention trial with continuous glucose monitoring data as
outcomes. Diabetes Technol Ther. 2018 Nov;20(11):758-766.
PubMed: PM30325656
39. McAuley SA, de Bock MI, Sundararajan V, et al. Effect of 6 months of hybrid closed-
loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial
protocol. BMJ Open. 2018 Jun 9;8(6):e020274.
PubMed: PM29886443
Pediatric Population
40. de Bock M, McAuley SA, Abraham MB, et al. Effect of 6 months hybrid closed-loop
insulin delivery in young people with type 1 diabetes: a randomised controlled trial
protocol. BMJ Open. 2018 Aug 13;8(8):e020275.
PubMed: PM30104309
Additional References
41. Health Quality Ontario. Continuous monitoring of glucose for type 1 diabetes: a health
technology assessment. Ont Health Technol Assess Ser. 2018;18(2):1-160.
PubMed: PM29541282
42. Hirsch IB, Verderese CA. Professional flash continuous glucose monitoring with
ambulatory glucose profile reporting to supplement A1C: rationale and practical
implementation. Endocr Pract. 2017 Nov;23(11):1333-1344.
PubMed: PM28816535
http://www.ncbi.nlm.nih.gov/pubmed/29174479http://www.ncbi.nlm.nih.gov/pubmed/29547046http://www.ncbi.nlm.nih.gov/pubmed/25998294http://www.ncbi.nlm.nih.gov/pubmed/30325656http://www.ncbi.nlm.nih.gov/pubmed/29886443http://www.ncbi.nlm.nih.gov/pubmed/30104309http://www.ncbi.nlm.nih.gov/pubmed/29541282http://www.ncbi.nlm.nih.gov/pubmed/28816535