Benefits of Adding Continuous Glucose Monitoring to Glycemic Load, Exercise, and Monitoring of Blood Glucose (GEM) for Adults With Type 2 Diabetes - Phase 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- University of Virginia
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- HbA1c
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine if the use of continuous glucose monitoring with the GEM lifestyle modification program (Glycemic load, Exercise and Monitoring glucose) will result in better diabetes control than routine care.
Detailed Description
Type 2 diabetes (t2d) is a major epidemic of the developing world which has huge fiscal consequences and many physical complications. It is thought to be brought on in part by contemporary easy access to high energy foods and reduced physical activity, resulting in increased belly fat that culminates in growing insulin resistance and subsequent hyperglycemia. Because of ease and efficacy of medication management, t2d is primarily managed with ever-escalating medication use, which significantly contributes to medical cost and possibly the progression of the disease itself. An effective supplement or alternative to medication management is lifestyle modification. Conventional lifestyle modification focuses on reducing body fat and insulin resistance through weight reduction from caloric restriction and aerobic exercise. Sustained routine application of this approach is limited because some individuals do not need to lose weight, some do not want to lose weight, others cannot lose weight, and when successful, lifelong weight reduction is difficult to sustain. A useful paradigm shift in lifestyle treatment of t2d might be to go from reducing calories to reducing postprandial glucose (PPG), the primary contributor to glycosylated hemoglobin (HbA1c). PPG spikes can be prevented by replacing high with low glycemic load foods and dampened by engaging in postprandial physical activity. This is exemplified by the integrated Glycemic load, Exercise and Monitoring glucose (GEM) program. It promotes choices of low glycemic load foods and increased physical activity, directed by glucose monitoring feedback. Glucose feedback can: 1) educate people as to what food choices minimize PPG and what physical activity choices directly lower PPG, 2) activate individuals when glucose is out of their desired range by alerting them to make choices to lower high glucose or raise low glucose, and 3) motivate individuals to repeat those choices that resulted in desirable glucose consequences. The educating, activating and motivating benefits of glucose feedback are thought to be qualitatively and quantitatively enhanced through continuous glucose monitoring (CGM). It is hypothesized that, compared to Routine Care (RC), GEM with CGM (GEM+CGM) administered to adults with t2d who are failing with oral medication management will result in better diabetes control (lower HbA1c), reduced medication management (less medication), and better psychological functioning (e.g. greater sense of empowerment) in the short term (3 month follow-up). Further, it is hypothesized that their reduction in HbA1c will be driven by a reduction in PPG.
Investigators
Daniel Cox, PhD
Professor, Departments of Psychiatry, Internal Medicine and Ophthalmology
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Between the ages of 21 and 80
- •Failed on an oral medication regimen (HbA1c \> 7.5%).
Exclusion Criteria
- •Takes insulin
- •Took medications in the last 3 months that impede weight loss (e.g., prednisone)
- •Pregnant or contemplating pregnancy in the next 12 months
- •Conditions that preclude increasing physical activity (e.g. severe neuropathy, cardiovascular disease, chronic obstructive pulmonary disease/emphysema, osteoarthritis, stroke)
- •Severe mental disease (e.g. manic depressive illness, severe depression, or active substance abuse)
- •Undergoing treatment for cancer
- •History of lactic acidosis
- •Marked renal impairment (eGFR \< 45; stage 3b chronic kidney disease)
- •Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)
- •Cannot read English.
Outcomes
Primary Outcomes
HbA1c
Time Frame: baseline, 3 months post-intervention
Change in HbA1c measured via blood test
Medication changes
Time Frame: baseline, 3 months post-intervention
Changes in prescribed medications (type and/or dosage)
Secondary Outcomes
- change in psychological functioning (depression questionnaire)(baseline, 3 months post-intervention)
- Exercise (Fitbit)(baseline, 3 months post-intervention)
- change in psychological functioning (diabetes knowledge questionnaire)(baseline, 3 months post-intervention)
- change in food choices (ASA24 survey)(baseline, 3 months post-intervention)
- change in psychological functioning (quality of life questionnaire)(baseline, 3 months post-intervention)
- Psychological functioning (PAID questionnaire)(baseline, 3 months post-intervention)
- change in food choices (energy bar selection)(baseline, 3 months post-intervention)
- change in psychological functioning (dietary habits questionnaire)(baseline, 3 months post-intervention)
- change in psychological functioning (numeracy questionnaire)(baseline, 3 months post-intervention)
- change in psychological functioning (empowerment questionnaire)(baseline, 3 months post-intervention)
- change in psychological functioning (attitude towards glucose monitoring questionnaire)(baseline, 3 months post-intervention)