Pilot Study of Connected Diabetes Technology

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Pilot Study of Connected Diabetes Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106440
• Other study ID #: 1447976
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: February 19, 2021

Study information

• Verified date: April 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Application Use
Use applications after initial diagnosis to share information with study team.

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency of blood glucose monitoring	How often patients are monitoring their blood sugar (documented in electronic medical record)	At each clinic visit until 6 months since diagnosis
Secondary	Hemoglobin A1c values	Hemoglobin A1c values collected at each clinic visit (documented in electronic medical record)	At each clinic visit until 6 months since diagnosis