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Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring (IDEAL CGM)

Primary Purpose

Type 1 Diabetes Mellitus, Continuous Glucose Monitor

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Web-Based Education

Social Support

Standard of Care

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to read and speak English
Diagnosed with type 1 diabetes (T1D) for > 3 months before consent is obtained
Aged >15 years and <24 years at time of enrollment
Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker
Must be using/initiating a Dexcom CGM

Exclusion Criteria:

Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol
Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol
Previous use of a CGM within the last 3 months
Unwilling or unlikely to return to clinic for a follow-up HbA1c test
Unwillingness to accept randomization

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Web-Based Educational Intervention

Standard of Care

Arm Description

Participants receiving the Web-Based Educational Intervention will be enrolled to the research protocol for six weeks of module-based learning and online discussion sessions and followed for a total of 3-months post CGM implementation to collect study measures.

Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.

Outcomes

Primary Outcome Measures

Adherence to CGM

Analyzing CGM data to determine if there is a difference in adherence between treatment and control group

Secondary Outcome Measures

HbA1c

The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.

CGM Satisfaction

Survey instrument that measures self-reported satisfaction with CGM use

CGM Self-Efficacy

Survey instrument that measures self-reported self-efficacy related to CGM use

Full Information

NCT ID

NCT03367351

First Posted

December 4, 2017

Last Updated

December 14, 2018

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT03367351

Brief Title

Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring

Acronym

IDEAL CGM

Official Title

Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

March 9, 2018 (Actual)

Primary Completion Date

November 1, 2018 (Actual)

Study Completion Date

November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus, Continuous Glucose Monitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, un-blinded intervention/control design

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Web-Based Educational Intervention

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

Placebo Comparator

Arm Description

Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.

Intervention Type

Behavioral

Intervention Name(s)

Web-Based Education

Intervention Description

Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.

Intervention Type

Behavioral

Intervention Name(s)

Social Support

Intervention Description

Engagement in peer-led CGM specific discussion boards

Intervention Type

Behavioral

Intervention Name(s)

Standard of Care

Intervention Description

Standard of Care - serves as the control group for the treatment arm

Primary Outcome Measure Information:

Title

Adherence to CGM

Description

Analyzing CGM data to determine if there is a difference in adherence between treatment and control group

Time Frame

3 months

Secondary Outcome Measure Information:

Title

HbA1c

Description

The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.

Time Frame

1-week run in, 3-months post implementation

Title

CGM Satisfaction

Description

Survey instrument that measures self-reported satisfaction with CGM use

Time Frame

1-week run in, 7 weeks

Title

CGM Self-Efficacy

Description

Survey instrument that measures self-reported self-efficacy related to CGM use

Time Frame

1-week run in, 7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to read and speak English Diagnosed with type 1 diabetes (T1D) for > 3 months before consent is obtained Aged >15 years and <24 years at time of enrollment Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker Must be using/initiating a Dexcom CGM Exclusion Criteria: Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol Previous use of a CGM within the last 3 months Unwilling or unlikely to return to clinic for a follow-up HbA1c test Unwillingness to accept randomization

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Madison B Smith, BSN, PhD Candidate

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32603

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33560234

Citation

Smith MB, Albanese-O'Neill A, Yao Y, Wilkie DJ, Haller MJ, Keenan GM. Feasibility of the Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitor (IDEAL CGM) Training and Follow-Up Support Intervention: Randomized Controlled Pilot Study. JMIR Diabetes. 2021 Feb 9;6(1):e15410. doi: 10.2196/15410.

Results Reference

derived

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Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring

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