Diabetes Mellitus, Type 1POPS!NCT03251846
Pediatrics Owning Performance Study
A study testing Pops! One personalized mobile platform in people with Diabetes Mellitus, Type 1, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Pops! One personalized mobile platform
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, 55102
Laure Gandrud, MD, 651-220-6624, laura.gandrud@childrensmn.org
Krista Mullen, BS, 507-581-6000, krista.mullen@childrensmn.org
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Pops! One personalized mobile platform
- Keywords
- Diabetes Mellitus, Type 1, self-monitoring blood glucose, diabetes mobile application, diabetes management device
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c from baseline to 6 months
Measured: 6 months
Secondary outcomes (5)
Testing frequency
Blood glucose testing frequency
Measured: 30 days prior to enrollment to 6 months post-enrollment
quality of life
Peds QL diabetes module
Measured: 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
Measured: 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
Measured: 30 days prior to enrollment to 6 months post-enrollment
Hypoglycemia
Frequency of hypoglycemic events during intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start17 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single-arm, single-subject clinical trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Pops! Diabetes Care
- Responsible party
- Principal investigator, Laura Gandrud, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251846
- Sponsor's protocol ID
- 1704-059
- Acronym
- POPS!
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatrics Owning Performance Study
- ClinicalTrials.gov ID
- NCT03251846
- Acronym / sponsor ID
- POPS! / 1704-059
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, self-monitoring blood glucose, diabetes mobile application, diabetes management device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- Pops! Diabetes Care
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- prospective, single-arm, single-subject clinical trial
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pops! One personalized mobile platformEnrolled 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. | Device | – |
Primary outcome
HbA1c
Time frame: 6 months
Change in HbA1c from baseline to 6 months
5 secondary outcomes
Testing frequency
Time frame: 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
Average blood glucose
Time frame: 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
Hypoglycemia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pops! One personalized mobile platform in people with Diabetes Mellitus, Type 1, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Gandrud, MD (651-220-6624, laura.gandrud@childrensmn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.