Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT03705260

Collaborator

Twine Clinical Consulting (Other)

Enrollment

Location

Arms

25.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Nov 26, 2018

Actual Primary Completion Date :

Feb 7, 2020

Actual Study Completion Date :

Jan 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

Hemoglobin A1C [1 year]
Hemoglobin A1C

Secondary Outcome Measures

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 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.
Blood Pressure [1 year]
Blood Pressure
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)
Change in rate of symptomatic hypoglycemia requiring medical intervention [Baseline to 1 year]
Change in rate of symptomatic hypoglycemia requiring medical intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Caroline Richardson, Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT03705260

Other Study ID Numbers:

HUM00147295

First Posted:

Oct 15, 2018

Last Update Posted:

Feb 4, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 4, 2021