Type 1 Diabetes Data Acquisition and Transfer Adherence S... | NCT03228004

Studies
Type 1 Diabetes Data Acquisition and Transfer Adherence Study

NCT03228004

Sponsor

University of Florida

Status

Completed

Last Update Posted

Apr 12, 2019Actual

Enrollment

53Actual

Phase

Phase 1

Conditions

Type 1 Diabetes Mellitus

Interventions

Glooko MeterSync

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 26, 2017Actual

Primary Completion Date

Apr 24, 2018Actual

Completion Date

Apr 8, 2019Actual

First Submitted Date

Jul 21, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2019

Last Update Posted Date

Apr 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	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.	Behavioral: Glooko MeterSync

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glooko MeterSync	Behavioral	The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved glycemic control	HbA1c	16 weeks
Frequency of data upload	The number of times glucose data is uploaded between clinic visits	16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anastasia Albanese-O'Neill, PhD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32611	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided