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Disseminating Evidence to Promote Patient‐Centered Diabetes Self‐
Management Strategies
Anne Gaglioti, MD, MS, FAAFPAssociate Professor of Family Medicine
Associate Director of Research, National Center for Primary CareDirector, Southeast Regional Clinicians Network
Morehouse School of Medicine
Community Health Center Association of MississippiSpring Clinical Conference
March 6, 2020
Funding Acknowledgement: This program was funded through a Patient‐Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award (EADI‐15896).
I have no conflicts of interest to disclose.
*Artwork by Dave Eggers
Goals for Today
1. Understand evidence from The MONITOR Trial on the impact of glucose self‐monitoring among patients with non‐insulin dependent diabetes on oral agents.
2. Identify the potential impact of glucose self‐monitoring on financial stress among FQHC patients.
“We are leading the creation and advancement of health equity”
“Strengthening the primary care system through education, research and
training to improve health outcomes while advancing health equity.”
Southeast Regional Clinicians Network
• 8 States • AHRQ Practice Based Research Network• Primary Care Associations (8)• Federally Qualified Health Centers (203)• Clinical Sites (1,778)• 368,000 square miles• Patients served: 4 million
What is a PBRN??
Practice Based Research Networks (PBRN) are groups of primary care clinicians and practices working together to answer
community‐based health care questions and translate research findings into practice. (Agency for Health Care Research and
Quality Definition)
Mission
The Southeast Regional Clinicians Network exists to improve health and advance health equity in the Southeastern US via practice‐based research in the primary care safety net and to serve as a resource for patients and providers in community health centers throughout the Southeastern United States.
Patient Centered Outcomes Research Institute: Mission
“PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high‐integrity, evidence‐based information that comes from research guided by patients, caregivers, and the broader healthcare
community.”
https://www.pcori.org/about‐us
Patient Centered Outcomes Research Institute
• Funding Acknowledgement: This program was funded through a Patient‐Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award, Dissemination Initiative (EADI‐15896).
• Funds “meaningful dissemination projects aimed at spreading awareness and increasing knowledge of new evidence from PCORI‐funded research, targeted directly to patients, clinicians, and others who can use this information to inform healthcare decisions”
• The MONITOR trial was also funded by PCORI at UNC Chapel Hill by Dr. Katrina Donahue and team
The Monitor Trial
No Clear Evidence or Expert Consensus to Guide Practice
For patients with non‐insulin dependent type II diabetes, there is no clear consensus and conflicting guidelines about whether patients should engage in self‐monitoring of blood glucose (SMBG) to improve their health outcomes.
Evidence is Mixed
Some randomized controlled trials (RCT) have shown a statistically significant small (0.2 to 0.3%) improvement in Hemoglobin A1c (HbA1c)
Some no improvement in glycemic control
Enhanced SMBG in RCTs improves effect to (0.5% improvement)
Statistical versus clinical significance
Guidelines and Professional Society Recommendations
SMBG Recommended
• American Diabetes Association
• American Association of Diabetes Educators
• International Diabetes Federation
SMBG NOT Recommended
• SGIM• AAFP• American Association of
Clinical Endocrinologists/ American College of Endocrinology
For Our Patients
• Improved lifestyle management• Improved medication management
Positives of SMBGPositives of SMBG
• Unclear benefit• Cost• Discomfort/time
Negatives of SMBGNegatives of SMBG
HOW DO PATIENTS AND CLINICIANS OPERATE IN AN UNCERTAIN ENVIRONMENT?
THE MONITOR TRIAL ADDRESSED THIS UNCERTAINTY AND
CLARIFIED GUIDELINES FOR PRACTICE
Pragmatic Clinical Trail on SMBG for Patients with Non‐Insulin Dependent Diabetes
First in US Conducted in primary care settings on patients who were managed by
primary care clinicians
15 practices from the University of North Carolina Physicians Network
*Patient perspectives were incorporated into all phases of the trial
Participants
• Participants– NIDDM ages 30 and older
– HbA1c 6.5‐9.5%– Managed by primary care clinician
– No history of severe hypoglycemia
Intervention Groups
• Continued regular care with PCC• Stopped testing
No SMBG(n=152)
• Study glucometer transferred readings to cloud for PCC
Once Daily SMBG (n=150)
• Glucometer provided messages based on target blood glucose
Once Daily SMBG plus Enhanced Tailored
Messaging (n=148)
Outcomes
• HbA1c at 52 weeks• Health related quality of life (HRQOL) • Physical and Mental scores on SF‐36
Primary
• Diabetes Specific• HRQOL and Self Efficacy
• Diabetes self care• Treatment satisfaction• Patient‐provider Communication
Secondary
• Finger infections• Severe hypoglycemia• ED/hospitalization
Adverse Events
Date of download: 10/02/2019 Copyright 2017 American Medical Association. All Rights Reserved.
From: Glucose Self-monitoring in Non–Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial
JAMA Intern Med. 2017;177(7):920-929. doi:10.1001/jamainternmed.2017.1233
SMBG Practices and Preferences
• 75% were engaging in SMBG at the time of enrollment
• 40% had a preference for continued SMBG
• 22% had a preference to not monitor
Results: Primary Outcomes
There were no significant differences in glycemic control or health related quality of life across
the three groups after 52 weeks
Results: Primary Outcomes
Copyright 2017 American Medical Association. All Rights Reserved.
JAMA Intern Med. 2017;177(7):920-929. doi:10.1001/jamainternmed.2017.1233
Results: Secondary Outcomes
SMBG not associated with any safety risks or adverse events
SMBG groups had greater differences in diabetes self‐care activities
There were no differences/improvements in:
Diabetes‐specific HRQoL Self‐efficacy Treatment
satisfactionPatient‐provider communication
Results: Secondary Outcomes
What About Special Groups?
• No differences across intervention groups based on patients based on: – Baseline degree of glycemic control, previous testing pattern, age, race, comorbidities, duration of diabetes
– Study was not powered to test for these differences
Changes in HA1c and SMBG Over the Study Period
JAMA Intern Med. 2017;177(7):920-929. doi:10.1001/jamainternmed.2017.1233
Limitations
• Most patients in the study had been SMBG• Willing to participate in study and be randomized to SMBG/no SMBG group
• Not all patients adhered to assigned group• Not applicable to patients using insulin• One state/health system
WHAT DO THESE RESULTS MEAN?
Conclusions
There were no differences in glycemic control or health related quality of life among people with non‐insulin dependent diabetes who monitored blood glucose versus those that did not monitor
Tailored messaging did not improve glycemic control
Patients and clinicians should engage in discussion and decision making about monitoring
WHY ARE THESE RESULTS IMPORTANT TO OUR HEALTH CENTER
PATIENTS?
The Cost of SMBG• Diabetic testing supplies
accounted for $34.6 billion in health care expendituresin 2017
• 70% of FQHC patients live below the FPL and nearly a quarter are uninsured
• Testing supplies can cost as little as $15 per month, but wide variation
American Diabetes Association. Economic costs of diabetes in the US in 2017. Diabetes care. 2018;41(5):917‐928.National Association of Community Health Centers. Community Health Center Chartbook, 2017.
Shifting Resources: Self Management
• Monetary resources and energy could be shifted to other areas of self‐management that have good evidence of impact on glycemic control.– Healthy foods– Exercise– Medication adherence
Shifting Resources: Time
• Chronic disease management visits are short
• Time can be maximized around counseling and discussion of other issues instead of reviewing blood sugar readings
Contextualizing Evidence for SMBG
• SMBG tends to have the greatest impact on glycemic control when:– Higher initial HbA1c levels– Structured and rigid timing of SMBG in relationship to meals
– Better adherence to SMBG– Shorter study periods (6 months)
1. Machry RV, Rados DV, de Gregório GR, Rodrigues TC. Self-monitoring blood glucose improves glycemic control in type 2 diabetes without intensive treatment: A systematic review and meta-analysis. Diabetes research and clinical practice. 2018 Aug 1;142:173-87.2. Mannucci E, Antenore A, Giorgino F, Scavini M. Effects of structured versus unstructured self‐monitoring of blood glucose on glucose control in patients with non‐insulin‐treated type 2 diabetes: a meta‐analysis of randomized controlled trials. Journal of diabetes science and technology. 2018 Jan;12(1):183‐9.3. Zhu H, Zhu Y, Leung SW. Is self‐monitoring of blood glucose effective in improving glycaemic control in type 2 diabetes without insulin treatment: a meta‐analysis of randomised controlled trials. BMJ open. 2016 Sep 1;6(9):e010524.
Psychological Impact of SMBG
• Some studies have found increases in self confidence and autonomy with structures SMBG
• Others have found worsened health related quality of life
• Individualize recommendations
1. Fisher L, Polonsky WH, Parkin CG, Jelsovsky Z, Petersen B, Wagner RS. The impact of structured blood glucose testing on attitudes toward self‐management among poorly controlled, insulin‐naïve patients with type 2 diabetes. Diabetes research and clinical practice. 2012 May 1;96(2):149‐55.2. Franciosi M, Pellegrini F, De Berardis G, Belfiglio M, Cavaliere D, Di Nardo B, Greenfield S, Kaplan SH, Sacco M, Tognoni G, Valentini M. The impact of blood glucose self-monitoring on metabolic control and quality of life in type 2 diabetic patients: an urgent need for better educational strategies. Diabetes care. 2001 Nov 1;24(11):1870-7.
PRACTICAL TIPS FOR SHARED DECISION MAKING FOR SBMG
Multi‐level Influential Factors
SMBG
Cost of Supplies
Clinician Preferences
Baseline Control
Time since diagnosis
Perceived discomfort
Potential for
adherence
Continuity
Perceptions of
monitoring
HA1C
The SHARE Approach: A Model for Shared Decisionmaking ‐ Fact Sheet. Content last reviewed September 2016. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/health‐literacy/curriculumtools/shareddecisionmaking/tools/sharefactsheet/index.html
SMBG Shared Decision Discussion
SERCN PCORI DISSEMINATION
Developing and Disseminating Tailored Materials
Patients with non‐insulin dependent diabetes
Clinicians
Quality Improvement Staff
Intensive Evidence Dissemination
Two Health Centers in Each of the 8 States
Recruitment over the next year
Dissemination will begin Fall of 2020
$1000 support for participation and all materials
Practice champion
Tracking of dissemination material reach
Baseline and follow up assessments of knowledge and attitudes around the evidence.
If Interested in Hearing More
Anne GagliotiNetwork [email protected]
Denita WalstonAssistant Network [email protected]
Follow us on Twitter @SERCN_NCPC
Take Home Points
This is the first practical clinical trial in the US that has shown no improvement in glycemic control or HRQoL with SMGB for patients with non‐insulin
dependent diabetes
The cost and burden of testing supplies for SMBG may be an issue for our health center
patients
Consider engaging with your patients in shared decision making around SMBG
SERCN is excited to partner 2 FQHCS in each state to
disseminate tailored materials around this evidence to
patients, clinicians, and QI staff in your health center
Responses, thoughts, questions, and connections are welcome!
Anne [email protected]
Tailored Message Examples