Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705260
• Other study ID #: HUM00147295
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: January 20, 2021

Study information

• Verified date: February 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 20, 2021
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Usual Care
Usual care from Primary Care Physician and dietitian.

Behavioral:
• Intensive Behavioral Intervention
The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.

Other:
• Monthly Screening for Risk
Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.

Locations

Country	Name	City	State
United States	Chelsea Health Center	Chelsea	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Twine Clinical Consulting

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C	Hemoglobin A1C	1 year
Secondary	Weight Change	Difference in patient's weight measured in pounds.	baseline to 1 year
Secondary	Change in diabetes medication requirements	Change in average daily doses of diabetes medications	baseline to 1 year
Secondary	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
Secondary	Blood Pressure	Blood Pressure	1 year
Secondary	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
Secondary	Change in rate of symptomatic hypoglycemia requiring medical intervention	Change in rate of symptomatic hypoglycemia requiring medical intervention	Baseline to 1 year