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CompletedNCT05163912Updated Aug 27, 2024

Virtual Physical Activity for Type 1 Diabetes

An interventional study of Virtual home intervention in Type 1 Diabetes, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Yale University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
14 Years to 19 Years
Sex
All
01

Study summary

A virtual group of teens with type 1 diabetes, led by young adults with type 1 diabetes, will play active videogames and discuss activity and health. This study will evaluate the program for feasibility and user satisfaction.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Exercise
  • Adolescent
  • Video games
  • Self-management
  • Social support
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age of 14-19 years
  • Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
  • Inadequate moderate-to-vigorous physical activity levels (defined as ≤3 days per week achieving ≥60min daily, which is ≤50% of the recommended 7 days per week)
  • English literacy
  • Own a continuous glucose monitor (Dexcom G4, G5, G6 [San Diego, CA], Abbott Freestyle Libre 2, 14-day [Chicago, IL], Medtronic Guardian 3, Enlite [Dublin, Ireland]) with enough supplies for 6 weeks (when available, we will provide these to those who do not own them, in which case they will be considered to meet this criteria).
  • Access to television or computer with HDMI or USB port.
  • Under regular care by a healthcare provider (defined as attending at least one appointment in the past year, plus access to verified 24hr phone number to reach the provider's team for insulin dose adjustments if assistance is needed)

Exclusion criteria

Exclusion Criteria:

  • A condition or disability besides type 1 diabetes that would preclude participation in group moderate-to-vigorous physical activity (e.g., cerebral palsy, current pregnancy)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Intervention

    Virtual home intervention

    Behavioral: Virtual home intervention

Interventions

  • BehavioralVirtual home intervention

    Group classes with active videogames and discussions

06

What researchers measure

Primary outcomes

  1. Adherence

    Number of group classes attended

    Time frame: 6 weeks

  2. Acceptability

    Score on a satisfaction survey that has been custom-designed for the components of this program. Scores range from 0 to 4. A higher score indicates greater satisfaction with the program.

    Time frame: 6 weeks

07

Study locations

2 sites
  • Yale University
    New Haven, Connecticut 06511, United States
  • Yale-New Haven Hospital
    New Haven, Connecticut 06511, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05163912
Lead sponsor
Yale University
Collaborators
Robert E. Leet and Clara Guthrie Patterson Trust
Responsible party
Sponsor
First posted
Dec 20, 2021
Start date
Jan 4, 2022
Primary completion
Aug 5, 2022
Completion
Aug 5, 2022
Last update
Aug 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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