Pediatrics Owning Performance Study

Pediatrics Owning Performance Study

Sponsors

Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Collaborator: Pops! Diabetes Care

Source Children's Hospitals and Clinics of Minnesota
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.

Overall Status Unknown status
Start Date July 17, 2017
Completion Date July 2018
Primary Completion Date July 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1c 6 months
Secondary Outcome
Measure Time Frame
Testing frequency 30 days prior to enrollment to 6 months post-enrollment
quality of life 30 days prior to enrollment to 6 months post-enrollment
Average blood glucose 30 days prior to enrollment to 6 months post-enrollment
Blood glucose variability 30 days prior to enrollment to 6 months post-enrollment
Hypoglycemia 6 months
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: Pops! One personalized mobile platform

Description: 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.

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

Gender: All

Minimum Age: 10 Years

Maximum Age: 25 Years

Healthy Volunteers: No

Overall Contact

Last Name: Laura Gandrud, MD

Phone: 651-220-6624

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Children's Hospitals and Clinics of Minnesota Laure Gandrud, MD 651-220-6624 [email protected]
Location Countries

United States

Verification Date

August 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Children's Hospitals and Clinics of Minnesota

Investigator Full Name: Laura Gandrud

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Acronym POPS!
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: prospective, single-arm, single-subject clinical trial

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov