Pilot Study of Connected Diabetes Technology

NCT ID: NCT04106440

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-18

Study Completion Date

2021-02-19

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Use of applications to share data
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Application Use

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Application Use

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California-Davis

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35037887 (View on PubMed)

Other Identifiers

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1447976

Identifier Type: -

Identifier Source: org_study_id

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