Recruiting

Observational Study

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT03251846

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

Interventions

Pops! One personalized mobile platform

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT03251846

Start date

Jul 17, 2017

Status verified date

Aug, 2017

Completion date

Jul, 2018

Anticipated

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Pops! One personalized mobile platform

Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months. Primary outcomes will be measured at baseline and 6-month follow-up.

Primary outcome measure

  • HbA1c [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Children's Hospitals and Clinics of Minnesota

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Aug 17, 2017

Last verified

Aug, 2017

Keywords

  • Diabetes Mellitus, Type 1
  • self-monitoring blood glucose
  • diabetes mobile application
  • diabetes management device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2017-08-17.