Pediatrics Owning Performance Study

Diabetes Mellitus, Type 1 Clinical Trial

— POPS!  

Official title:

Pediatrics Owning Performance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251846
• Other study ID #: 1704-059
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 15, 2017
• Start date: July 17, 2017
• Est. completion date: July 2018

Study information

• Verified date: August 2017
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: Laura Gandrud, MD
• Phone: 651-220-6624
• Email: laura.gandrud[@]childrensmn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota	Pops! Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c from baseline to 6 months	6 months
Secondary	Testing frequency	Blood glucose testing frequency	30 days prior to enrollment to 6 months post-enrollment
Secondary	quality of life	Peds QL diabetes module	30 days prior to enrollment to 6 months post-enrollment
Secondary	Average blood glucose	Average blood glucose during 30 days prior to enrollment and during the 6 month intervention	30 days prior to enrollment to 6 months post-enrollment
Secondary	Blood glucose variability	Blood glucose variability during 30 during prior to enrollment and during the 6 months of intervention	30 days prior to enrollment to 6 months post-enrollment
Secondary	Hypoglycemia	Frequency of hypoglycemic events during intervention	6 months