Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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).

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Usual Care
* Behavioral: Intensive Behavioral Intervention
* Other: Monthly Screening for Risk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |