Back to resultsQuality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Intensive Behavioral Intervention
Monthly Screening for Risk
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Chelsea Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Comparator- High Risk
Comparator- Well Controlled
Enhanced Care- High Risk
Enhanced Care- Well Controlled.
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Hemoglobin A1C
Hemoglobin A1C
Secondary Outcome Measures
Weight Change
Difference in patient's weight measured in pounds.
Change in diabetes medication requirements
Change in average daily doses of diabetes medications
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.
Blood Pressure
Blood Pressure
Change in rate of Micro-vascular complications
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
Change in rate of symptomatic hypoglycemia requiring medical intervention
Full Information
NCT ID
NCT03705260
First Posted
October 8, 2018
Last Updated
February 3, 2021
Sponsor
University of Michigan
Collaborators
Twine Clinical Consulting
1. Study Identification
Unique Protocol Identification Number
NCT03705260
Brief Title
Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Twine Clinical Consulting
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comparator- High Risk
Arm Type
Active Comparator
Arm 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.
Arm Title
Comparator- Well Controlled
Arm Type
Active Comparator
Arm 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.
Arm Title
Enhanced Care- High Risk
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Care- Well Controlled.
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care from Primary Care Physician and dietitian.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Behavioral Intervention
Intervention Description
The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
Intervention Type
Other
Intervention Name(s)
Monthly Screening for Risk
Intervention Description
Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Description
Hemoglobin A1C
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Weight Change
Description
Difference in patient's weight measured in pounds.
Time Frame
baseline to 1 year
Title
Change in diabetes medication requirements
Description
Change in average daily doses of diabetes medications
Time Frame
baseline to 1 year
Title
Change in percentage of time glucose is out of range
Description
Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM.
Time Frame
baseline to 1 year
Title
Blood Pressure
Description
Blood Pressure
Time Frame
1 year
Title
Change in rate of Micro-vascular complications
Description
Change in rate of micro-vascular complications. (The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy)
Time Frame
Baseline to 1 Year
Title
Change in rate of symptomatic hypoglycemia requiring medical intervention
Description
Change in rate of symptomatic hypoglycemia requiring medical intervention
Time Frame
Baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Richardson, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chelsea Health Center
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
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