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

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ClinicalTrials.gov Identifier: NCT03367351
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Continuous Glucose Monitor Behavioral: Web-Based Education Behavioral: Social Support Behavioral: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, un-blinded intervention/control design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Web-Based Educational Intervention
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.
Behavioral: Web-Based Education
Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.

Behavioral: Social Support
Engagement in peer-led CGM specific discussion boards

Placebo Comparator: Standard of Care
Participants will receive standard clinical care. Similar study measures will be collected to compare between groups.
Behavioral: Standard of Care
Standard of Care - serves as the control group for the treatment arm




Primary Outcome Measures :
  1. Adherence to CGM [ Time Frame: 3 months ]
    Analyzing CGM data to determine if there is a difference in adherence between treatment and control group


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 1-week run in, 3-months post implementation ]
    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.

  2. CGM Satisfaction [ Time Frame: 1-week run in, 7 weeks ]
    Survey instrument that measures self-reported satisfaction with CGM use

  3. CGM Self-Efficacy [ Time Frame: 1-week run in, 7 weeks ]
    Survey instrument that measures self-reported self-efficacy related to CGM use



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol
  2. 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
  3. Previous use of a CGM within the last 3 months
  4. Unwilling or unlikely to return to clinic for a follow-up HbA1c test
  5. Unwillingness to accept randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367351


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32603
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Madison B Smith, BSN, PhD Candidate University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03367351     History of Changes
Other Study ID Numbers: UFT1DCGM2017
IRB201701822 ( Other Identifier: University of Florida )
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases