Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06374186
• Lead Sponsor: University of Missouri, Kansas City

Brief Summary

This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management.

Detailed Description

A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM. Individuals will be randomized in a 1:1 ratio to the intervention group or the control group. Randomization will be blocked and stratified by long-acting insulin and GLP1 medication use. All participants will be given a Continuous Glucose Monitor (CGM) to assess real-time blood sugar levels and establish CM rewards for those assigned to the treatment group.

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Diagnosed with type 2 diabetes
2. Age 18 to 65
3. Hemoglobin A1c (blood draw or point-of-care) test available within the last 3 months
4. Most recent hemoglobin A1c result between 8.0 and 11.0
5. Currently receiving treatment for diabetes by a licensed healthcare provider.
6. Reliable access to a personal smart phone that is compatible with CGM
7. English speaking

Exclusion Criteria

1. Type 1 diabetes
2. Secondary type 2 diabetes (diagnosis secondary to other medical conditions such as pancreatitis, Cystic Fibrosis, or Cushing disease)
3. Prescribed short-acting (mealtime) insulin as part of diabetes treatment plan
4. Known or acknowledged active substance use disorder or that would interfere or negatively impact participation in the study
5. Diagnosis of a medical/psychiatric condition that would prevent participation in the study (e.g., Intellectual Disability, Alzheimer's disease, Traumatic Brain Injury, Schizophrenia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time in target blood glucose range per CGM	baseline to 14 weeks	Percent time with blood glucose between 70 to 180 mg/dL
Hemoglobin A1C	baseline to 12 weeks	laboratory value

Secondary Outcome Measures

Name	Time	Method
Diabetes Quality of Life Brief Inventory	baseline to 12 weeks	self-report questionnaire
PROMIS Medication Adherence Scale	Baseline to 12 weeks	self-report questionnaire
Perceived Dietary Adherence Questionnaire	Baseline to 12 weeks	self-report questionnaire
Diabetes Distress Scale	Baseline to 12 weeks	self-report questionnaire
Motivation and Confidence Ruler	Baseline to 12 weeks	self-report questionnaire

Trial Locations

Locations (1)

University of Missouri - Kansas City School of Medicine; 🇺🇸 Kansas City, Missouri, United States