Reducing Diabetes Distress in Teenagers with Type 1 Diabetes
This study is testing a program called Supporting Teen Problem Solving (STePS) to help teenagers with Type 1 Diabetes (T1D) manage the emotional challenges of living with their condition, known as diabetes distress. It also compares STePS to standard diabetes education. The study aims to see how well STePS works in real-world settings and if it helps teens feel better and improve their blood sugar control (Time in Range). We are looking for 360 teenagers, aged 14 to 18, who have had T1D for at least one year, use daily insulin, and can access telehealth. Success will be measured by changes in diabetes distress and Time in Range over 16.5 months. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 360 participants. It compares two approaches: Supporting Teen Problem Solving (STePS) and Diabetes Education.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the intervention ends, for a total of 16.5 months from the start.
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A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jill Weissberg-Benchell, Ph.D. · PRINCIPAL_INVESTIGATOR · Ann & Robert H Lurie Children's Hospital of Chicago
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Inclusion
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What this trial measures
- Diabetes DistressDistress is assessed at baseline, end of intervention (month 4.5), and then 6 (month 10.5) and 12 (month 16.5) months post intervention
To assess clinically meaningful changes in DD, the minimal clinically important difference (MCID) represents a threshold value of change in the score that represents a meaningful change in comparison to a statistically significant change. For the PAID measures assessing distress we selected a stringent definition of MCID where the MCID is beyond the 95% confidence interval of the expected random variation in the distress score. For the PAID measures, that would be 8.3. Therefore, if participant's scores on the distress measures are reduced by \>8.3 at the end of 6 months, then we will conclude that STePS has clinically meaningfully reduced distress.
- Time in RangeBaseline, end of intervention (month 4.5) and again 6 (month 10.5) and 12 (month 16.5) months post intervention
TIR is the percentage of time spent in the target glucose range of 70-180 mg/dL. Participants already using a continuous glucose monitor (CGM) will have their data downloaded at each of the 4 assessment time points. We will download data from the past 10 days at each assessment time-point, documenting percent time in range, percent time below 70 mg/dl and percent time above 180 mg/dL. For those not currently using a personal CGM we will give them a Dexcom Gen 6 Pro in a blinded fashion to use at each of the assessment time points. We are using blinded CGM for those without a personal CGM because data suggest that merely using a personal CGM can significantly improve TIR. Since giving participants a personal CGM with access to their data could in and of itself affect TIR, we have chosen to use blinded CGM for those participants so that we can collect the TIR range, but not negatively impact our ability to assess the TIR outcomes from participating in STePS.