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OpenTrials
Completed

NCT Number: NCT03705260

Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chelsea Health Center

Chelsea, Michigan, 48118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

Usual care from Primary Care Physician and dietitian.

Intensive Behavioral Intervention

Behavioral

The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.

Monthly Screening for Risk

Other

Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.

Primary outcomes

  1. Hemoglobin A1C

    Time frame: 1 year

    Hemoglobin A1C

Secondary outcomes

  1. Weight Change

    Time frame: baseline to 1 year

    Difference in patient's weight measured in pounds.

  2. Change in diabetes medication requirements

    Time frame: baseline to 1 year

    Change in average daily doses of diabetes medications

  3. Change in percentage of time glucose is out of range

    Time frame: baseline to 1 year

    Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM.

  4. Blood Pressure

    Time frame: 1 year

    Blood Pressure

  5. Change in rate of Micro-vascular complications

    Time frame: Baseline to 1 Year

    Change in rate of micro-vascular complications. (The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy)

  6. Change in rate of symptomatic hypoglycemia requiring medical intervention

    Time frame: Baseline to 1 year

    Change in rate of symptomatic hypoglycemia requiring medical intervention

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Twine Clinical Consulting

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 15, 2018
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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