Clinical trial NCT06374186: Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City
Official title: COntinuous Glucose Monitoring, Contingency Management, and Motivational InTerviewing for Patients With TypE 2 Diabetes in Kansas City
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Glucose
contingency management
motivational interviewing
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time in target blood glucose range per CGM
timeFrame: baseline to 14 weeks
measure: Hemoglobin A1C
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Diabetes Quality of Life Brief Inventory
timeFrame: baseline to 12 weeks
measure: Diabetes Distress Scale
timeFrame: Baseline to 12 weeks
measure: PROMIS Medication Adherence Scale
timeFrame: Baseline to 12 weeks
measure: Perceived Dietary Adherence Questionnaire
timeFrame: Baseline to 12 weeks
measure: Motivation and Confidence Ruler
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Missouri - Kansas City School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Jared Bruce, PhD
role: PRINCIPAL_INVESTIGATOR
References: