Pilot Study of Connected Diabetes Technology
1 other identifier
interventional
41
1 country
1
Brief Summary
To test the hypothesis that remote sharing of health data - including measured blood glucose values as well as patient-reported carbohydrate counts and insulin doses - with the UC Davis Pediatric Diabetes team via connected health applications is feasible for pediatric patients with newly diagnosed type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2021
CompletedApril 20, 2021
April 1, 2021
1.3 years
September 24, 2019
April 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Connected Health Survey
Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.
1 month after diabetes diagnosis
Connected Health Survey
Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.
6 months after diabetes diagnosis
Secondary Outcomes (2)
Frequency of blood glucose monitoring
At each clinic visit until 6 months since diagnosis
Hemoglobin A1c values
At each clinic visit until 6 months since diagnosis
Study Arms (2)
Application Use
EXPERIMENTALParticipants will be asked to use applications to track food intake, carbohydrate counts, insulin delivered, and blood sugar values and share the data with the study team.
Standard of Care
NO INTERVENTIONThe control group will receive usual care during their hospitalizations at the time of diabetes diagnosis, and during the time between hospital discharge and first visit to the UCD Pediatric Diabetes clinic.
Interventions
Use applications after initial diagnosis to share information with study team.
Eligibility Criteria
You may qualify if:
- Newly diagnosed with T1D in the past 6 weeks
- Daily access to the internet via a wireless connection
You may not qualify if:
- Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care
- Primary caregiver does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California-Davis
Sacramento, California, 95817, United States
Related Publications (1)
Crossen S, Romero C, Reggiardo A, Michel J, Glaser N. Feasibility and Impact of Remote Glucose Monitoring Among Patients With Newly Diagnosed Type 1 Diabetes: Single-Center Pilot Study. JMIR Diabetes. 2022 Jan 17;7(1):e33639. doi: 10.2196/33639.
PMID: 35037887DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2019
First Posted
September 27, 2019
Study Start
October 18, 2019
Primary Completion
February 19, 2021
Study Completion
February 19, 2021
Last Updated
April 20, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share