Lifestyle Modification for Type 2 Diabetes Involving Reduction of After-meal Blood Glucose Elevations

Study Overview
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Brief Summary
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The purpose of this study is to determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Half of the participants will continue their routine medical care, and half will receive five sessions of GEM in addition to their routine care. The two groups will be assessed using diabetes-relevant medical, behavioral and psychological measures.

Official Title
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Self-Monitoring of Blood Glucose (SMBG) as an Educational Tool and a Negative Feedback Loop to Reinforce Blood Glucose Lowering and Discourage Blood Glucose Elevating Self-Management Behaviors in Adults With T2DM

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: GEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes within the past 5 years Age >24 and <80 years HbA1c >7.0% Approval of primary care physician to participate Exclusion Criteria: Currently using, or used within the last 3 months, medications that directly lower BG (e.g., insulin, sulfonylureas, glinides, or DPP-4 inhibitors). Currently using, or used within the last 3 months, thiazides at doses above HCTZ 25 mg or equivalent, or loop diuretics above furosemide 20mg or equivalent. Currently pregnant or contemplating pregnancy in the coming year Currently using, or used within the last 3 months, medications that impede weight loss (e.g., prednisone) Having conditions that preclude increasing physical activity, e.g. severe neuropathy, active cardiovascular disease, emphysema, osteoarthritis, stroke. Undergoing cancer treatment History of lactic acidosis Diagnosed with renal impairment

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br>Participants continue their routine medical care for type 2 diabetes | |
| Experimental: GEM<br>Participants receive the GEM (Glycemic load, Exercise, and Monitoring blood glucose) lifestyle modification program and continue their routine medical care for type 2 diabetes. | Behavioral: GEM<br>* GEM is an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activity guided by systematic blood glucose monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline glycosylated hemoglobin at 6 months | HbA1c | 0 and 6 months |