NCT06374186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

April 15, 2024

Last Update Submit

January 5, 2026

Conditions

Keywords

Type 2 DiabetesGlucosecontingency managementmotivational interviewing

Outcome Measures

Primary Outcomes (2)

  • Time in target blood glucose range per CGM

    Percent time with blood glucose between 70 to 180 mg/dL

    baseline to 14 weeks

  • Hemoglobin A1C

    laboratory value

    baseline to 12 weeks

Secondary Outcomes (5)

  • Diabetes Quality of Life Brief Inventory

    baseline to 12 weeks

  • Diabetes Distress Scale

    Baseline to 12 weeks

  • PROMIS Medication Adherence Scale

    Baseline to 12 weeks

  • Perceived Dietary Adherence Questionnaire

    Baseline to 12 weeks

  • Motivation and Confidence Ruler

    Baseline to 12 weeks

Study Arms (2)

Behavioral Intervention with financial rewards and coaching

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Contingency management and motivational interviewing
Behavioral Intervention with financial rewards and coaching
ControlBEHAVIORAL

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.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri - Kansas City School of Medicine

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Behavior TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jared Bruce, PhD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 18, 2024

Study Start

May 1, 2024

Primary Completion

July 29, 2025

Study Completion

August 12, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations