Type 1 Diabetes Data Acquisition and Transfer Adherence Study

NCT ID: NCT03228004

Last Updated: 2019-04-12

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

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-26

Study Completion Date

2019-04-08

Brief Summary

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The purpose of this pilot study is to determine if training and support, combined with reminders to facilitate glucose data sharing with the diabetes care team in between clinic visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have HbA1c levels above target.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.

Group Type EXPERIMENTAL

Glooko MeterSync

Intervention Type BEHAVIORAL

The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.

Interventions

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Glooko MeterSync

The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis with T1D at least 6 months before consent is obtained
* Aged ≥ 2 years and ≤17 years at time of enrollment
* Must have access to a smartphone, tablet or computer at home with wireless connectivity
* Last HbA1c of ≥7.6% and ≤11%
* Using fixed doses, multiple daily injections or an insulin pump as primary diabetes management regimen
* Ability to read and speak English
* Patient at UF Health Pediatric Diabetes Clinic

Exclusion Criteria

* Significant medical comorbidity in the child or adolescent that could, in the opinion of the PI, affect participant's capacity to complete study follow up
* Inability to read and speak English
* Not using insulin therapy
* Lack of access to mobile device or computer with wireless internet connectivity
* Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data upload
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anastasia Albanese-O'Neill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201700818

Identifier Type: -

Identifier Source: org_study_id

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