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

Type 2 Diabetes Clinical Trial

— COMMITTED2-KC  

Official title:

COntinuous Glucose Monitoring, Contingency Management, and Motivational InTerviewing for Patients With TypE 2 Diabetes in Kansas City

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374186
• Other study ID #: 2095072
• Secondary ID: 2095072
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 8, 2025

Study information

• Verified date: April 2024
• Source: University of Missouri, Kansas City
• Contact: Carrie Kriz, MS
• Phone: 816-512-7473
• Email: mckinleycr[@]umkc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 8, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Behavioral Intervention with financial rewards and coaching
Participants will receive variable financial incentives based on their engagement with the continuous glucose monitor and meeting diabetes treatment goals. In addition, they will participate in three motivational interviewing sessions focused on their diabetes management. Participants will continue to receive their diabetes treatment as usual.
• Control
Participants will only receive a continuous glucose monitor, which they may engage with as desired and no further intervention. Participants in the control group will continue to receive their diabetes treatment as usual.

Locations

Country	Name	City	State
United States	University of Missouri - Kansas City School of Medicine	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in target blood glucose range per CGM	Percent time with blood glucose between 70 to 180 mg/dL	baseline to 14 weeks
Primary	Hemoglobin A1C	laboratory value	baseline to 12 weeks
Secondary	Diabetes Quality of Life Brief Inventory	self-report questionnaire	baseline to 12 weeks
Secondary	Diabetes Distress Scale	self-report questionnaire	Baseline to 12 weeks
Secondary	PROMIS Medication Adherence Scale	self-report questionnaire	Baseline to 12 weeks
Secondary	Perceived Dietary Adherence Questionnaire	self-report questionnaire	Baseline to 12 weeks
Secondary	Motivation and Confidence Ruler	self-report questionnaire	Baseline to 12 weeks