NCT05163912

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

December 9, 2021

Last Update Submit

August 26, 2024

Conditions

Keywords

ExerciseAdolescentVideo gamesSelf-managementSocial support

Outcome Measures

Primary Outcomes (2)

  • Adherence

    Number of group classes attended

    6 weeks

  • 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.

    6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Virtual home intervention

Behavioral: Virtual home intervention

Interventions

Group classes with active videogames and discussions

Intervention

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University

New Haven, Connecticut, 06511, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Mak SS, Nally LM, Montoya J, Marrero R, DeJonckheere M, Joiner KL, Nam S, Ash GI. An Exergames Program for Adolescents With Type 1 Diabetes: Qualitative Study of Acceptability. JMIR Diabetes. 2025 May 28;10:e65665. doi: 10.2196/65665.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 20, 2021

Study Start

January 4, 2022

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations