CClinicalTrials.gg
CompletedNCT04106440Updated Apr 20, 2021

Pilot Study of Connected Diabetes Technology

An interventional study of Application Use in Diabetes Mellitus, Type 1, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by University of California, Davis · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
1 Year to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 41 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed with T1D in the past 6 weeks
  • Daily access to the internet via a wireless connection

Exclusion criteria

Exclusion Criteria:

  • Does not plan to attend the UC Davis Pediatric Endocrinology clinic for future diabetes care
  • Primary caregiver does not speak English
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Application Use

    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.

    Behavioral: Application Use

  • No intervention
    Standard of Care

    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.

Interventions

  • BehavioralApplication Use

    Use applications after initial diagnosis to share information with study team.

06

What researchers measure

Primary outcomes

  1. Connected Health Survey

    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

  2. Connected Health Survey

    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 outcomes

  1. Frequency of blood glucose monitoring

    How often patients are monitoring their blood sugar (documented in electronic medical record)

    Time frame: At each clinic visit until 6 months since diagnosis

  2. Hemoglobin A1c values

    Hemoglobin A1c values collected at each clinic visit (documented in electronic medical record)

    Time frame: At each clinic visit until 6 months since diagnosis

07

Study locations

1 site
  • University of California-Davis
    Sacramento, California 95817, United States
08

References and documents

Publications

  • 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. PubMed 35037887 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04106440
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Sep 27, 2019
Start date
Oct 18, 2019
Primary completion
Feb 19, 2021
Completion
Feb 19, 2021
Last update
Apr 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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