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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432391
• Other study ID #: 16293
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: April 28, 2015
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• GEM
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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	LifeScan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline glycosylated hemoglobin at 6 months	HbA1c	0 and 6 months	No