Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT03705260
• Lead Sponsor: University of Michigan

Brief Summary

The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-11-26
• Primary Completion: 2020-02-07
• Study Completion: 2021-01-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
• Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
• HbA1C >8 for the high-risk sub-cohort

Exclusion Criteria

• Individuals for whom tight control (ie A1C < 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
• Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
• Women who are pregnant or breast feeding
• Individuals who had previous bariatric surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	1 year	Hemoglobin A1C

Secondary Outcome Measures

Name	Time	Method
Change in rate of Micro-vascular complications	Baseline to 1 Year	Change in rate of micro-vascular complications. (The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy)
Weight Change	baseline to 1 year	Difference in patient's weight measured in pounds.
Change in diabetes medication requirements	baseline to 1 year	Change in average daily doses of diabetes medications
Change in rate of symptomatic hypoglycemia requiring medical intervention	Baseline to 1 year	Change in rate of symptomatic hypoglycemia requiring medical intervention
Blood Pressure	1 year	Blood Pressure
Change in percentage of time glucose is out of range	baseline to 1 year	Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM.

Trial Locations

Locations (1)

Chelsea Health Center; 🇺🇸 Chelsea, Michigan, United States