NCT03251846

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

August 14, 2017

Last Update Submit

August 15, 2017

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1self-monitoring blood glucosediabetes mobile applicationdiabetes management device

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change in HbA1c from baseline to 6 months

    6 months

Secondary Outcomes (5)

  • 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

Interventions

Pops! One personalized mobile platformDEVICE

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

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Laura Gandrud, MD

CONTACT

651-220-6624laura.gandrud@childrensmn.org

Krista Mullen, BS

CONTACT

507-581-6000krista.mullen@childrensmn.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective, single-arm, single-subject clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

July 17, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)