- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03251846
Pediatrics Owning Performance Study (POPS!)
August 15, 2017 updated by: Laura Gandrud, Children's Hospitals and Clinics of Minnesota
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura Gandrud, MD
- Phone Number: 651-220-6624
- Email: laura.gandrud@childrensmn.org
Study Contact Backup
- Name: Krista Mullen, BS
- Phone Number: 507-581-6000
- Email: krista.mullen@childrensmn.org
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55102
- Recruiting
- Children's Hospitals and Clinics of Minnesota
-
Contact:
- Krista Mullen, BS
- Phone Number: 507-581-6000
- Email: krista.mullen@childrensmn.org
-
Contact:
- Laure Gandrud, MD
- Phone Number: 651-220-6624
- Email: laura.gandrud@childrensmn.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 6 months
|
Change in HbA1c from baseline to 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Testing frequency
Time Frame: 30 days prior to enrollment to 6 months post-enrollment
|
Blood glucose testing frequency
|
30 days prior to enrollment to 6 months post-enrollment
|
quality of life
Time Frame: 30 days prior to enrollment to 6 months post-enrollment
|
Peds QL diabetes module
|
30 days prior to enrollment to 6 months post-enrollment
|
Average blood glucose
Time Frame: 30 days prior to enrollment to 6 months post-enrollment
|
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
Time Frame: 30 days prior to enrollment to 6 months post-enrollment
|
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
Time Frame: 6 months
|
Frequency of hypoglycemic events during intervention
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2017
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
August 17, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1704-059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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