Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Usual Care; Behavioral: Intensive Behavioral Intervention; Other: Monthly Screening for Risk

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Chelsea, Michigan, United States, 48118
      • Chelsea Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparator- High Risk; 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.	Other: Usual Care; Usual care from Primary Care Physician and dietitian.
Active Comparator: Comparator- Well Controlled; 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.	Other: Usual Care; Usual care from Primary Care Physician and dietitian.
Experimental: Enhanced Care- High Risk; 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.	Behavioral: Intensive Behavioral Intervention; The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
Experimental: Enhanced Care- Well Controlled.; 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.	Other: Usual Care; Usual care from Primary Care Physician and dietitian.; Other: Monthly Screening for Risk; Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	Hemoglobin A1C	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Twine Clinical Consulting
• Investigators: Principal Investigator: Caroline Richardson, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HUM00147295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No