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

NCT03367351 | Completed

• 2 other identifiers: UFT1DCGM2017IRB201701822
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

• Adherence to CGM

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

  3 months

Secondary Outcomes (3)

• HbA1c

  1-week run in, 3-months post implementation

• CGM Satisfaction

  1-week run in, 7 weeks

• CGM Self-Efficacy

  1-week run in, 7 weeks

Study Arms (2)

Web-Based Educational Intervention

EXPERIMENTAL

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; Behavioral: Social Support

Standard of Care

PLACEBO COMPARATOR

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

Behavioral: Standard of Care

Interventions

Web-Based Education BEHAVIORAL

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

Web-Based Educational Intervention

Social Support BEHAVIORAL

Engagement in peer-led CGM specific discussion boards

Web-Based Educational Intervention

Standard of Care BEHAVIORAL

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

Standard of Care

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32603, United States

Location

Related Publications (1)

• 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.

  PMID: 33560234 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Madison B Smith, BSN, PhD Candidate

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, un-blinded intervention/control design

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: March 9, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)