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OpenTrials
Completed

NCT Number: NCT04106440

Pilot Study of Connected Diabetes Technology

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application Use

Behavioral

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

Primary outcomes

  1. Connected Health Survey

    Time frame: 1 month after diabetes diagnosis

    Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.

  2. Connected Health Survey

    Time frame: 6 months after diabetes diagnosis

    Parent reported survey to determine how often families review blood sugar numbers and the ease of use of the applications.

Secondary outcomes

  1. Frequency of blood glucose monitoring

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

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

  2. Hemoglobin A1c values

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

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2019
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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