Type 1 DiabetesNCT05163912
Virtual Physical Activity for Type 1 Diabetes
A study testing Virtual home intervention in people with Type 1 Diabetes, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Virtual home intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2022to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale University
New Haven, Connecticut, 06511
Yale-New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Virtual home intervention
- Keywords
- Exercise, Adolescent, Video games, Self-management, Social support
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual home interventionBehavioural
Group classes with active videogames and discussions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Virtual home intervention Receives: Behavioral: Virtual home intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Number of group classes attended
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start4 Jan 2022
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert E. Leet and Clara Guthrie Patterson Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163912
- Sponsor's protocol ID
- 2000030105
- Other IDs
- 852679
- Status last verified
- Aug 2024
- First submitted
- 9 Dec 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40238214
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05163912
- Acronym / sponsor ID
- 2000030105
- Conditions
- Type 1 Diabetes
- Keywords
- Exercise, Adolescent, Video games, Self-management, Social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Robert E. Leet and Clara Guthrie Patterson Trust
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Virtual home interventionVirtual home intervention |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual home interventionGroup classes with active videogames and discussions | Behavioural | Intervention |
Primary outcome
Adherence
Time frame: 6 weeks
Number of group classes attended
Acceptability
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 40238214Mak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual home intervention in people with Type 1 Diabetes, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.