Pediatrics Owning Performance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pediatrics Owning Performance Study

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Pops! One personalized mobile platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, single-arm, single-subject clinical trial
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c from baseline to 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing frequency | Blood glucose testing frequency | 30 days prior to enrollment to 6 months post-enrollment | 
| quality of life | Peds QL diabetes module | 30 days prior to enrollment to 6 months post-enrollment | 
| 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 | 
| 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 | 
| Hypoglycemia | Frequency of hypoglycemic events during intervention | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, self-monitoring blood glucose, diabetes mobile application, diabetes management device