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
Verified date | February 2021 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Chelsea Health Center | Chelsea | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Twine Clinical Consulting |
United States,
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 |
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