Overview:

The purpose of the study is to see if a new treatment for individuals with type 1 diabetes who take less insulin than they need (for weight control or other emotional reasons) is helpful for improving diabetes management. This treatment combines the use of a smartphone application with weekly therapy.

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Study Details:

Dr. Rhonda Merwin is the principal investigator.

 

If you choose to participate in this study, you will be asked to complete 3 months of app-supported treatment and 6 months of follow-up. You will be asked to complete four assessments: before treatment, at the end of treatment, and 3 and 6 months after completing the treatment. These assessments include completing questionnaires, interviews, and blood draws for measurement of HbA1c. You will also be asked to wear a continuous glucose monitor for 7-days before and after the treatment and report on your eating and insulin dosing while doing so.

 

On your first appointment day at Duke University Medical Center, you will be asked to sign a release for the Duke study team to correspond your physician managing your diabetes care and obtain medical records. You will be required to maintain regular care with your provider throughout the duration of the study.

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You will also be asked to complete questionnaires and interviews about your eating and diabetes management. You will provide a blood sample to assess your current HbA1c and will be fitted with a CGM monitor. This involves the insertion of a small glucose sensor under the skin of your abdomen. After leaving the clinic, you will wear the glucose sensor for 7-days and return for a second clinic visit where data will be downloaded and the glucose sensor will be removed.

 

You will return to Duke University Medical Center for a diabetes education session administered by a Certified Diabetes Educator after which you will begin the treatment. The treatment includes weekly 1-hour therapy sessions for a period of 3 months (a total of 12 sessions) and the use of the app outside of sessions. Therapy sessions will be based on cognitive behavioral therapy and focus on helping you develop approach-based coping strategies and engage in diabetes management behaviors even when it feels difficult to do so. At the end of this 3-month treatment period, you will return to the clinic to complete questionnaires and interviews asking about your eating, diabetes management and experience of the treatment, and for placement of the CGM for an additional 7-day period of BG monitoring. You will be asked to complete two additional assessments at the clinic, which consist of completing questionnaires and providing a blood sample to measure your current HbA1C, 3-months and 6-months after treatment.

 

Compensation:

You will receive a total of $200 for completing the study that is dispersed over the 9 month study period. You will receive $25 when you complete baseline enrollment, $50 at the end of treatment (at month 3 of the study), $50 at your 3-month follow-up assessment (at month 6 of the study), and $75 at your 6-month follow-up assessment (at month 9 of the study).