Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

NCT03705260 | Completed

• 1 other identifier: HUM00147295
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  Hemoglobin A1C

  1 year

Secondary Outcomes (6)

• Weight Change

  baseline to 1 year

• Change in diabetes medication requirements

  baseline to 1 year

• Change in percentage of time glucose is out of range

  baseline to 1 year

• Blood Pressure

  1 year

• Change in rate of Micro-vascular complications

  Baseline to 1 Year

Study Arms (4)

Comparator- High Risk

ACTIVE COMPARATOR

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

Comparator- Well Controlled

ACTIVE COMPARATOR

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

Enhanced Care- High Risk

EXPERIMENTAL

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

Enhanced Care- Well Controlled.

EXPERIMENTAL

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; Other: Monthly Screening for Risk

Interventions

Usual Care OTHER

Usual care from Primary Care Physician and dietitian.

Comparator- High Risk; Comparator- Well Controlled; Enhanced Care- Well Controlled.

Intensive Behavioral Intervention BEHAVIORAL

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

Enhanced Care- High Risk

Monthly Screening for Risk OTHER

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

Enhanced Care- Well Controlled.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Twine Clinical Consulting: collaborator

Study Sites (1)

Chelsea Health Center

Chelsea, Michigan, 48118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Risk

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Caroline Richardson, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: November 26, 2018
• Primary Completion: February 7, 2020
• Study Completion: January 20, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)