Type 2 Diabetes Mellitus
Conditions
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).
Interventions
OTHERUsual Care
Usual care from Primary Care Physician and dietitian.
BEHAVIORALIntensive Behavioral Intervention
The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
OTHERMonthly Screening for Risk
Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.
Sponsors
Twine Clinical Consulting
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 1 year | Hemoglobin A1C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diabetes medication requirements | baseline to 1 year | Change in average daily doses of diabetes medications |
| Change in percentage of time glucose is out of range | baseline to 1 year | Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM. |
| Weight Change | baseline to 1 year | Difference in patient's weight measured in pounds. |
| Change in rate of Micro-vascular complications | Baseline to 1 Year | 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 | Baseline to 1 year | Change in rate of symptomatic hypoglycemia requiring medical intervention |
| Blood Pressure | 1 year | Blood Pressure |
Countries
United States
Outcome results
None listed