Back to resultsPilot Study of Connected Diabetes Technology
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Application Use
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed with T1D in the past 6 weeks
- Daily access to the internet via a wireless connection
Exclusion Criteria:
- Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care
- Primary caregiver does not speak English
Sites / Locations
- University of California-Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Application Use
Standard of Care
Arm Description
Participants 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.
The 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.
Outcomes
Primary Outcome Measures
Connected Health Survey
Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.
Connected Health Survey
Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.
Secondary Outcome Measures
Frequency of blood glucose monitoring
How often patients are monitoring their blood sugar (documented in electronic medical record)
Hemoglobin A1c values
Hemoglobin A1c values collected at each clinic visit (documented in electronic medical record)
Full Information
NCT ID
NCT04106440
First Posted
September 24, 2019
Last Updated
April 17, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04106440
Brief Title
Pilot Study of Connected Diabetes Technology
Official Title
Pilot Study of Connected Diabetes Technology
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Use of applications to share data
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Application Use
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Application Use
Intervention Description
Use applications after initial diagnosis to share information with study team.
Primary Outcome Measure Information:
Title
Connected Health Survey
Description
Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.
Time Frame
1 month after diabetes diagnosis
Title
Connected Health Survey
Description
Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.
Time Frame
6 months after diabetes diagnosis
Secondary Outcome Measure Information:
Title
Frequency of blood glucose monitoring
Description
How often patients are monitoring their blood sugar (documented in electronic medical record)
Time Frame
At each clinic visit until 6 months since diagnosis
Title
Hemoglobin A1c values
Description
Hemoglobin A1c values collected at each clinic visit (documented in electronic medical record)
Time Frame
At each clinic visit until 6 months since diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed with T1D in the past 6 weeks
Daily access to the internet via a wireless connection
Exclusion Criteria:
Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care
Primary caregiver does not speak English
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35037887
Citation
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.
Results Reference
derived
Learn more about this trial
Pilot Study of Connected Diabetes Technology
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