Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Usual Care; Behavioral: Intensive Behavioral Intervention; Other: Monthly Screening for Risk

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator- High Risk	Usual Care	A high risk sub group of those assigned to the comparator arm will be identified by their most recent A1C \> 8. Patients in this group will receive usual care from their Primary Care Physician and dietitian.
Enhanced Care- Well Controlled.	Monthly Screening for Risk	The low risk sub group from the enhanced care arm (A1C \< 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group.
Enhanced Care- High Risk	Intensive Behavioral Intervention	A high risk sub group of those assigned to the enhanced care arm will be identified by their most recent A1C \> 8. Patients in this group will receive the intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
Comparator- Well Controlled	Usual Care	The low risk sub group from the comparator arm (A1C \< 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their Primary Care Physician and their dietitian.
Enhanced Care- Well Controlled.	Usual Care	The low risk sub group from the enhanced care arm (A1C \< 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	1 year	Hemoglobin A1C

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

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