Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication

University of Michigan1 site in 1 country64 target enrollmentNovember 26, 2018

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: University of Michigan
Enrollment: 64
Locations: 1
Primary Endpoint: Hemoglobin A1C
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 26, 2018

End Date

January 20, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Caroline Richardson

Professor

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hemoglobin A1C

Time Frame: 1 year

Hemoglobin A1C

Secondary Outcomes

Change in rate of Micro-vascular complications(Baseline to 1 Year)
Change in percentage of time glucose is out of range(baseline to 1 year)
Weight Change(baseline to 1 year)
Change in diabetes medication requirements(baseline to 1 year)
Change in rate of symptomatic hypoglycemia requiring medical intervention(Baseline to 1 year)
Blood Pressure(1 year)