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| ID | Type | Description | Link |
|---|---|---|---|
| 1DP3DK097705-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic intervention to increase use of continuous glucose monitors (CGM) in adolescents and young adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her research team at University of Connecticut School of Medicine (UConn Health). The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. A 6-month pilot trial will be conducted with up to 20 patients receiving the intervention. The specific aims are:
The purpose of this pilot project is to evaluate the effectiveness of a behavioral economic intervention to increase use of continuous glucose monitors (CGM) in adolescents and young adults with T1D. This study will be done in conjunction with Nancy Petry, PhD and her research team at University of Connecticut School of Medicine (UConn Health). The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. A 6-month pilot trial will be conducted with up to 20 patients receiving the intervention. The specific aims are:
Evaluations will be conducted at time of CGM initiation, and 6, 13, 19, 26, and 39 weeks after treatment initiation to assess effects of the intervention and estimate effect sizes.
In addition to the primary aims, secondary outcomes will also be evaluated. Continued use of CGM is expected to improve aspects of diabetes management and daily functioning. Predictors of continued CGM usage and improvements in A1c will also be evaluated.
Results from this pilot study will be instrumental for guiding a subsequent, larger and longer term randomized study for evaluating reinforcement interventions for improving uptake of CGM, other diabetes-related adherence behaviors, and long-term outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reinforcement for wearing CGM | Experimental | The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinforcement for wearing CGM | Behavioral | The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Proportion of days participants wear the CGM | CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITYâ„¢, Carelink) will be used to calculate the change in the proportion of days when the patient wore the CGM. At the 6, 13, 19, 26 and 39 week study visits, data will be uploaded and exported into an Excel file to calculate the days. | up to 39 weeks |
| Change in the number of weeks participants wear the CGM on at least 5 days | CGM data uploaded to a CGM tracking website (e.g., Dexcom CLARITYâ„¢, Carelink) will be used to calculate the change in the number of weeks when the CGM is worn at least 5 days. At the 6, 13, 19, 26 and 39 week study visits, CGM data will be uploaded and exported into an Excel file to calculate the number of weeks when it is worn at least 5 days. | up to 39 weeks |
| Change in A1c | Change in A1c will be evaluated at the week 6, 13, 19, 26 and 39 week study visits by finger prick (DCA Vantage,Siemons). | up to 39 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Tamborlane, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |