Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
Status
Completed
Conditions
Type 2 Diabetes Mellitus
Treatments
Other: Monthly Screening for Risk
Behavioral: Intensive Behavioral Intervention
Other: Usual Care
Details and patient eligibility
About
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).
Enrollment
64 patients
Sex
All
Ages
21+ years old
Volunteers
No 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
Trial design
Primary purpose
Health Services Research
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
64 participants in 4 patient groups
Comparator- High Risk
Active Comparator group
Description:
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.
Treatment:
Other: Usual Care
Comparator- Well Controlled
Active Comparator group
Description:
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.
Treatment:
Other: Usual Care
Enhanced Care- High Risk
Experimental group
Description:
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.
Treatment:
Behavioral: Intensive Behavioral Intervention
Enhanced Care- Well Controlled.
Experimental group
Description:
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.
Treatment:
Other: Monthly Screening for Risk
Other: Usual Care
Trial contacts and locations
1
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