Clinical trial NCT03251846: Pediatrics Owning Performance Study
Official title: Pediatrics Owning Performance Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
self-monitoring blood glucose
diabetes mobile application
diabetes management device
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
Collaborators: name: Pops! Diabetes Care
First posted: 2017-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single-arm, single-subject clinical trial
Primary purpose: TREATMENT

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. The primary aim of this study is to determine if the POPS diabetes management system can improve diabetes control in the adolescent and young adult population. The investigators hypothesize that use of the POPS diabetes management device and mobile application (app) will be associated with lower HbA1C after 6-months of use in adolescent and young adult T1D patients.

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 McNeely Diabetes Clinic and satellite clinics during routine office visits over a 6-month period until recruitment goals are met. Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months with periodic check-ins and follow-ups. Primary outcome, HbA1c, will be measured at baseline and 6-month follow-up. Secondary aims include assessment of blood glucose testing frequency and quality of life scores following 6-months of device and app use. The investigators will also describe sustained use over the study period, average blood glucose and variability, and frequency of hypoglycemic events (blood glucose \<70). Historical data for each patient will also be recorded from medical records, with each patient serving as their own comparative control.

Eligibility criteria: Inclusion Criteria:

1. Type 1 diabetes, diagnosed at least 6 months prior to enrollment
2. Aged ≥10 years, ≤25 years
3. Daily insulin of any type, administered as multiple daily injections (MDI) for at least 90 days prior to enrollment
4. Latest HbA1c ≥8.0%, ≤10.5%
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
6. User of iPhone 5 or above with iOS above 10.0
7. English-speaking
8. 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 Criteria:

1. Continuous glucose monitor user at time of enrollment or considering CGM use in the next 6 months
2. Concurrent participation in another study that may influence results
3. On insulin pump at time of recruitment or considering pump use in the next 6 months
4. Inability to perform self-care behaviors due to co-morbidities such as mental health disorder, developmental delay, or other prohibitive physical condition (blindness, etc)
5. Participation in a diabetes clinical trial intervention in the 12 months prior to enrollment

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Testing frequency
timeFrame: 30 days prior to enrollment to 6 months post-enrollment
measure: quality of life
timeFrame: 30 days prior to enrollment to 6 months post-enrollment
measure: Average blood glucose
timeFrame: 30 days prior to enrollment to 6 months post-enrollment
measure: Blood glucose variability
timeFrame: 30 days prior to enrollment to 6 months post-enrollment
measure: Hypoglycemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
References: