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| ID | Type | Description | Link |
|---|---|---|---|
| 2095072 | Other Identifier | UMKC IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention with financial rewards and coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Quality of Life Brief Inventory | self-report questionnaire | baseline to 12 weeks |
| Diabetes Distress Scale | self-report questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Bruce, PhD | University of Missouri, Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri - Kansas City School of Medicine | Kansas City | Missouri | 64108 | United States |
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A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM.
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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.
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| Control | Behavioral | 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. |
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| Baseline to 12 weeks |
| PROMIS Medication Adherence Scale | self-report questionnaire | Baseline to 12 weeks |
| Perceived Dietary Adherence Questionnaire | self-report questionnaire | Baseline to 12 weeks |
| Motivation and Confidence Ruler | self-report questionnaire | Baseline to 12 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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