Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

• ClinicalTrials.gov Identifier: NCT03705260
• Recruitment Status: Completed
• First Posted: October 15, 2018
• Last Update Posted: February 4, 2021
• Sponsor: University of Michigan
• Collaborator: Twine Clinical Consulting
• Information provided by (Responsible Party): Caroline Richardson, University of Michigan

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Other: Usual Care; Behavioral: Intensive Behavioral Intervention; Other: Monthly Screening for Risk	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
• Actual Study Start Date: November 26, 2018
• Actual Primary Completion Date: February 7, 2020
• Actual Study Completion Date: January 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hemoglobin A1C [ Time Frame: 1 year ]
   Hemoglobin A1C

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Michigan

Chelsea Health Center

Chelsea, Michigan, United States, 48118

Sponsors and Collaborators

University of Michigan

Twine Clinical Consulting

Investigators

• Principal Investigator: Caroline Richardson, M.D.; University of Michigan

More Information

• Responsible Party: Caroline Richardson, Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03705260
• Other Study ID Numbers: HUM00147295
• First Posted: October 15, 2018
• Last Update Posted: February 4, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases