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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02432391

Enrollment

Registered

2015-05-04

Start date

2013-05-31

Completion date

2015-01-31

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

BEHAVIORALGEM

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

24 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline glycosylated hemoglobin at 6 months	0 and 6 months	HbA1c

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026