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OpenTrials
Completed

NCT Number: NCT03367351

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Continuous Glucose Monitor Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32603, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based education

Behavioral

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

Social Support

Behavioral

Engagement in peer-led CGM specific discussion boards

Standard of Care

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: IDEAL CGM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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