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Pediatrics Owning Performance Study (POPS!)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pops! One personalized mobile platform
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, self-monitoring blood glucose, diabetes mobile application, diabetes management device

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospitals and Clinics of MinnesotaRecruiting

Outcomes

Primary Outcome Measures

HbA1c
Change in HbA1c from baseline to 6 months

Secondary Outcome Measures

Testing frequency
Blood glucose testing frequency
quality of life
Peds QL diabetes module
Average blood glucose
Average blood glucose during 30 days prior to enrollment and during the 6 month intervention
Blood glucose variability
Blood glucose variability during 30 during prior to enrollment and during the 6 months of intervention
Hypoglycemia
Frequency of hypoglycemic events during intervention

Full Information

First Posted
August 14, 2017
Last Updated
August 15, 2017
Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
Pops! Diabetes Care
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1. Study Identification

Unique Protocol Identification Number
NCT03251846
Brief Title
Pediatrics Owning Performance Study
Acronym
POPS!
Official Title
Pediatrics Owning Performance Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
Pops! Diabetes Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, self-monitoring blood glucose, diabetes mobile application, diabetes management device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, single-arm, single-subject clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pops! One personalized mobile platform
Intervention 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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Change in HbA1c from baseline to 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Testing frequency
Description
Blood glucose testing frequency
Time Frame
30 days prior to enrollment to 6 months post-enrollment
Title
quality of life
Description
Peds QL diabetes module
Time Frame
30 days prior to enrollment to 6 months post-enrollment
Title
Average blood glucose
Description
Average blood glucose during 30 days prior to enrollment and during the 6 month intervention
Time Frame
30 days prior to enrollment to 6 months post-enrollment
Title
Blood glucose variability
Description
Blood glucose variability during 30 during prior to enrollment and during the 6 months of intervention
Time Frame
30 days prior to enrollment to 6 months post-enrollment
Title
Hypoglycemia
Description
Frequency of hypoglycemic events during intervention
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Gandrud, MD
Phone
651-220-6624
Email
laura.gandrud@childrensmn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Krista Mullen, BS
Phone
507-581-6000
Email
krista.mullen@childrensmn.org
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Gandrud, MD
Phone
651-220-6624
Email
laura.gandrud@childrensmn.org
First Name & Middle Initial & Last Name & Degree
Krista Mullen, BS
Phone
507-581-6000
Email
krista.mullen@childrensmn.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Pediatrics Owning Performance Study

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