Status:
UNKNOWN
Pediatrics Owning Performance Study
Lead Sponsor:
Children's Hospitals and Clinics of Minnesota
Collaborating Sponsors:
Pops! Diabetes Care
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
10-25 years
Phase:
NA
Brief Summary
A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes. T...
Detailed Description
This is a prospective, single-arm, single-subject clinical trial to study outcomes related to device use in the pediatric diabetes population. Patients will be recruited at the Children's Minnesota Mc...
Eligibility Criteria
Inclusion
- Type 1 diabetes, diagnosed at least 6 months prior to enrollment
- Aged ≥10 years, ≤25 years
- Daily insulin of any type, administered as multiple daily injections (MDI) for at least 90 days prior to enrollment
- Latest HbA1c ≥8.0%, ≤10.5%
- Average self-blood glucose measurement frequency ≥2 per day and ≤4.5 per day based on meter download spanning 28-day period prior to qualifying HbA1c measurement
- User of iPhone 5 or above with iOS above 10.0
- English-speaking
- Patient must be willing to only use POPS device to check blood glucose for duration of study (except in case of technical failure or emergency)
Exclusion
- Continuous glucose monitor user at time of enrollment or considering CGM use in the next 6 months
- Concurrent participation in another study that may influence results
- On insulin pump at time of recruitment or considering pump use in the next 6 months
- Inability to perform self-care behaviors due to co-morbidities such as mental health disorder, developmental delay, or other prohibitive physical condition (blindness, etc)
- Participation in a diabetes clinical trial intervention in the 12 months prior to enrollment
Key Trial Info
Start Date :
July 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03251846
Start Date
July 17 2017
End Date
July 1 2018
Last Update
August 17 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102