Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Glucose, contingency management, motivational interviewing
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALControl
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.
Sponsors
University of Missouri, Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in target blood glucose range per CGM | baseline to 14 weeks | Percent time with blood glucose between 70 to 180 mg/dL |
| Hemoglobin A1C | baseline to 12 weeks | laboratory value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale | Baseline to 12 weeks | self-report questionnaire |
| PROMIS Medication Adherence Scale | Baseline to 12 weeks | self-report questionnaire |
| Motivation and Confidence Ruler | Baseline to 12 weeks | self-report questionnaire |
| Perceived Dietary Adherence Questionnaire | Baseline to 12 weeks | self-report questionnaire |
| Diabetes Quality of Life Brief Inventory | baseline to 12 weeks | self-report questionnaire |
Countries
United States
Outcome results
None listed