Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City (COMMITTED2-KC)

University of Missouri, Kansas City

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: Behavioral Intervention with financial rewards and coaching; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06374186

2095072 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Behavioral Intervention with financial rewards and coaching

Experimental group

Description:

Individuals in the treatment group will receive financial rewards (contingency management) and diabetes coaching (motivational interviewing) in addition to wearing a continuous glucose monitor while receiving their usual diabetes treatment.

Treatment:

Behavioral: Behavioral Intervention with financial rewards and coaching

Control

Active Comparator group

Description:

Individuals in the control group will not receive any interventions and will only wear a continuous glucose monitor while receiving their usual diabetes treatment.

Treatment:

Behavioral: Control