Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus

An observational study of Type 1 Diabetes, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D) The main question[s] it aims to answer are: Does the intervention increase the amount of text messages between the mHealth software and participants? Do the text messages from the Nudge software increase… Read more about this study

Who is it for?: Ages 13 to 21 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: NUDGE
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 25 Jul 2024to 26 Jun 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 to 21 years
All sexes
No healthy volunteers
Child, Adult

Study population: Patients 12.00 to 21.99 with Type 1 Diabetes

Who may be able to join

Participants 12.00-21.99 years old
Participants with a physician confirmed T1D diagnosis.
T1D diagnosis was at least 6 months prior to study enrollment
Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
Participants must be using a continuous glucose monitor (CGM)
Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.

Who cannot join

Participants with evidence of type 2 or monogenic diabetes.
Participants with a comorbid chronic condition (e.g., renal disease).
Participants with presence of severe psychiatric disorders.
Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy
Kansas City, Missouri, 64111

Other trials in United States

About this study

The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D)

The main question[s] it aims to answer are:

Does the intervention increase the amount of text messages between the mHealth software and participants?
Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants?
Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?

Participants will:

Receive text messages from the Nudge software
Report physical activity goals via the text messages to the Nudge software
Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation)
Complete surveys at the beginning of participation
Complete daily surveys while wearing the devices
Complete surveys at the end of participation
Record physical activity in study surveys

Conditions: Type 1 Diabetes
Being tested: NUDGE
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NUDGEOther
NUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message.

What is being measured

The primary outcome is the main question the study is designed to answer.

%Daily Text Messages Exchanged Between Youth and the NUDGE Bot
percent of daily text messages exchanged between youth and the NUDGE bot
Measured: Through study completion, an average of 3.5 months
Moderate to Vigorous Physical Activity (MVPA) Levels
Participants' MVPA levels
Measured: Day 1, 30 and 90

Secondary outcomes (3)

%Days That Youth Wear the Actigraph
Percent of days that youth wear the actigraph
Measured: Day 1, 30 and 90
%Daily Physical Activity (PA) Schedules That Participants Complete
percent of daily PA schedules that participants complete
Measured: Day 1, 30 and 90
Change in Participant HbA1c
Change in participant HbA1c
Measured: Through study completion, an average of 3.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 202426 Jun 2025

First posted31 Aug 2023
Study start25 Jul 2024
Primary completion26 Jun 2025
Study completion26 Jun 2025

Why it stopped: PI decision based on reduced staffing and funds.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06018844
Sponsor's protocol ID: STUDY00002143
Status last verified: Aug 2025
First submitted: 7 Aug 2023
Last updated: 19 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Dabelea D. The accelerating epidemic of childhood diabetes. Lancet. 2009 Jun 13;373(9680):1999-2000. doi: 10.1016/S0140-6736(09)60874-6. Epub 2009 May 27. No abstract available.
PubMed 19481250
Vehik K, Hamman RF, Lezotte D, Norris JM, Klingensmith G, Bloch C, Rewers M, Dabelea D. Increasing incidence of type 1 diabetes in 0- to 17-year-old Colorado youth. Diabetes Care. 2007 Mar;30(3):503-9. doi: 10.2337/dc06-1837.
PubMed 17327312
Mayer-Davis EJ, Dabelea D, Lawrence JM. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Jul 20;377(3):301. doi: 10.1056/NEJMc1706291. No abstract available.
PubMed 28723318
Miller GF, Coffield E, Leroy Z, Wallin R. Prevalence and Costs of Five Chronic Conditions in Children. J Sch Nurs. 2016 Oct;32(5):357-64. doi: 10.1177/1059840516641190. Epub 2016 Apr 4.
PubMed 27044668
American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S163-S182. doi: 10.2337/dc20-S013.
PubMed 31862756
Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.
PubMed 28126459
Miculis CP, De Campos W, da Silva Boguszweski MC. Correlation between glycemic control and physical activity level in adolescents and children with type 1 diabetes. J Phys Act Health. 2015 Feb;12(2):232-7. doi: 10.1123/jpah.2013-0024. Epub 2014 Feb 5.
PubMed 24508755
Nguyen T, Obeid J, Walker RG, Krause MP, Hawke TJ, McAssey K, Vandermeulen J, Timmons BW. Fitness and physical activity in youth with type 1 diabetes mellitus in good or poor glycemic control. Pediatr Diabetes. 2015 Feb;16(1):48-57. doi: 10.1111/pedi.12117. Epub 2014 Jan 20.
PubMed 24444038
Tully C, Aronow L, Mackey E, Streisand R. Physical Activity in Youth With Type 1 Diabetes: a Review. Curr Diab Rep. 2016 Sep;16(9):85. doi: 10.1007/s11892-016-0779-6.
PubMed 27475093
Cushing CC, Mitchell TB, Bejarano CM, Walters RW, Crick CJ, Noser AE. Bidirectional Associations Between Psychological States and Physical Activity in Adolescents: A mHealth Pilot Study. J Pediatr Psychol. 2017 Jun 1;42(5):559-568. doi: 10.1093/jpepsy/jsw099.
PubMed 28131985
Lenhart, A. (2015). Teens, Social Media, & Technology Overview. Retrieved from http://pewinternet.org/2015/04/09/teens-social-media-technology-2015/
Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017 May 1;171(5):461-469. doi: 10.1001/jamapediatrics.2017.0042.
PubMed 28319239
Yang CH, Maher JP, Conroy DE. Implementation of behavior change techniques in mobile applications for physical activity. Am J Prev Med. 2015 Apr;48(4):452-5. doi: 10.1016/j.amepre.2014.10.010. Epub 2015 Jan 6.
PubMed 25576494
Brannon EE, Cushing CC. A systematic review: is there an app for that? Translational science of pediatric behavior change for physical activity and dietary interventions. J Pediatr Psychol. 2015 May;40(4):373-84. doi: 10.1093/jpepsy/jsu108. Epub 2014 Dec 13.
PubMed 25502745
Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009 Nov;28(6):690-701. doi: 10.1037/a0016136.
PubMed 19916637

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT06018844
Acronym / sponsor ID: STUDY00002143
Conditions: Type 1 Diabetes
Study type: Observational
Recruitment status: TerminatedReason stopped: PI decision based on reduced staffing and funds.
Enrolment: 1 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Collaborators: University of Kansas, Nemours Children's Clinic
Study start: 25 Jul 2024 (actual)
Primary completion: 26 Jun 2025 (actual)
Study completion: 26 Jun 2025 (actual)
First posted: 31 Aug 2023 (actual)
Results: Posted 19 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D)

The main question[s] it aims to answer are:

Does the intervention increase the amount of text messages between the mHealth software and participants?
Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants?
Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?

Participants will:

Receive text messages from the Nudge software
Report physical activity goals via the text messages to the Nudge software
Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation)
Complete surveys at the beginning of participation
Complete daily surveys while wearing the devices
Complete surveys at the end of participation
Record physical activity in study surveys

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 13 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Patients 12.00 to 21.99 with Type 1 Diabetes

Key inclusion criteria (6 listed)

Participants 12.00-21.99 years old
Participants with a physician confirmed T1D diagnosis.
T1D diagnosis was at least 6 months prior to study enrollment
Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
Participants must be using a continuous glucose monitor (CGM)

Key exclusion criteria (5 listed)

Participants with evidence of type 2 or monogenic diabetes.
Participants with a comorbid chronic condition (e.g., renal disease).
Participants with presence of severe psychiatric disorders.
Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.

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
NUDGENUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message.	Other	–

Primary outcome

%Daily Text Messages Exchanged Between Youth and the NUDGE Bot
Time frame: Through study completion, an average of 3.5 months
percent of daily text messages exchanged between youth and the NUDGE bot
Moderate to Vigorous Physical Activity (MVPA) Levels
Time frame: Day 1, 30 and 90
Participants' MVPA levels

3 secondary outcomes

%Days That Youth Wear the Actigraph
Time frame: Day 1, 30 and 90
%Daily Physical Activity (PA) Schedules That Participants Complete
Time frame: Day 1, 30 and 90
Change in Participant HbA1c
Time frame: Through study completion, an average of 3.5 months

Results and safety

Results posted to the registry on 19 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Arm	1	0

Primary outcome: %Daily Text Messages Exchanged Between Youth and the NUDGE Bot

Time frame: Through study completion, an average of 3.5 months

Population analysed: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

Primary outcome: Moderate to Vigorous Physical Activity (MVPA) Levels

Time frame: Day 1, 30 and 90

Population analysed: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Arm	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19481250Dabelea D. The accelerating epidemic of childhood diabetes. Lancet. 2009 Jun 13;373(9680):1999-2000. doi: 10.1016/S0140-6736(09)60874-6. Epub 2009 May 27. No abstract available.
Background: PubMed 17327312Vehik K, Hamman RF, Lezotte D, Norris JM, Klingensmith G, Bloch C, Rewers M, Dabelea D. Increasing incidence of type 1 diabetes in 0- to 17-year-old Colorado youth. Diabetes Care. 2007 Mar;30(3):503-9. doi: 10.2337/dc06-1837.
Background: PubMed 28723318Mayer-Davis EJ, Dabelea D, Lawrence JM. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Jul 20;377(3):301. doi: 10.1056/NEJMc1706291. No abstract available.
Background: PubMed 27044668Miller GF, Coffield E, Leroy Z, Wallin R. Prevalence and Costs of Five Chronic Conditions in Children. J Sch Nurs. 2016 Oct;32(5):357-64. doi: 10.1177/1059840516641190. Epub 2016 Apr 4.
Background: PubMed 31862756American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S163-S182. doi: 10.2337/dc20-S013.
Background: PubMed 28126459Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.
Background: PubMed 24508755Miculis CP, De Campos W, da Silva Boguszweski MC. Correlation between glycemic control and physical activity level in adolescents and children with type 1 diabetes. J Phys Act Health. 2015 Feb;12(2):232-7. doi: 10.1123/jpah.2013-0024. Epub 2014 Feb 5.
Background: PubMed 24444038Nguyen T, Obeid J, Walker RG, Krause MP, Hawke TJ, McAssey K, Vandermeulen J, Timmons BW. Fitness and physical activity in youth with type 1 diabetes mellitus in good or poor glycemic control. Pediatr Diabetes. 2015 Feb;16(1):48-57. doi: 10.1111/pedi.12117. Epub 2014 Jan 20.
Background: PubMed 27475093Tully C, Aronow L, Mackey E, Streisand R. Physical Activity in Youth With Type 1 Diabetes: a Review. Curr Diab Rep. 2016 Sep;16(9):85. doi: 10.1007/s11892-016-0779-6.
Background: PubMed 28131985Cushing CC, Mitchell TB, Bejarano CM, Walters RW, Crick CJ, Noser AE. Bidirectional Associations Between Psychological States and Physical Activity in Adolescents: A mHealth Pilot Study. J Pediatr Psychol. 2017 Jun 1;42(5):559-568. doi: 10.1093/jpepsy/jsw099.
BackgroundLenhart, A. (2015). Teens, Social Media, & Technology Overview. Retrieved from http://pewinternet.org/2015/04/09/teens-social-media-technology-2015/
Background: PubMed 28319239Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017 May 1;171(5):461-469. doi: 10.1001/jamapediatrics.2017.0042.
Individual participant dataSharing planned: Undecided

Related trials for Type 1 Diabetes

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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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.

Mark Clements, MD principal investigator

Children's Mercy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Children's Mercy Hospital Kansas City at 1 site 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

%Daily Text Messages Exchanged Between Youth and the NUDGE Bot (time frame: Through study completion, an average of 3.5 months). 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 NCT06018844, which also lists 33 linked publications.

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 19 Aug 2025.