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NCT06374186 | Not yet recruiting | Type 2 Diabetes

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

Condition or disease

Type 2 Diabetes

Intervention/treatment

Behavioral Intervention with financial rewards and coaching

Control

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 40 participants
Masking : Single
Masking Description : Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition.
Primary Purpose : Treatment
Official Title : COntinuous Glucose Monitoring, Contingency Management, and Motivational InTerviewing for Patients With TypE 2 Diabetes in Kansas City
Actual Study Start Date : May 1, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : April 8, 2025
Arm Intervention/treatment

Experimental: Behavioral Intervention with financial rewards and coaching

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.

Behavioral: Behavioral Intervention with financial rewards and coaching

Active Comparator: Control

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

Behavioral: Control
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Diagnosed with type 2 diabetes
  • Age 18 to 65
  • Hemoglobin A1c (blood draw or point-of-care) test available within the last 3 months
  • Most recent hemoglobin A1c result between 8.0 and 11.0
  • Currently receiving treatment for diabetes by a licensed healthcare provider.
  • Reliable access to a personal smart phone that is compatible with CGM
  • English speaking
Exclusion Criteria
  • Type 1 diabetes
  • Secondary type 2 diabetes (diagnosis secondary to other medical conditions such as pancreatitis, Cystic Fibrosis, or Cushing disease)
  • Prescribed short-acting (mealtime) insulin as part of diabetes treatment plan
  • Known or acknowledged active substance use disorder or that would interfere or negatively impact participation in the study
  • Diagnosis of a medical/psychiatric condition that would prevent participation in the study (e.g., Intellectual Disability, Alzheimer's disease, Traumatic Brain Injury, Schizophrenia)
Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City

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

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Locations

Not yet recruiting

United States, Missouri

University of Missouri - Kansas City School of Medicine

Kansas City, missouri, United States, 64108