Type 1 DiabetesNCT06129994
Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
An observational study of Type 1 Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression)… Read more about this study
- Who is it for?
- Ages 13 to 26 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Observational
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 10 Aug 2025
- Phase
- Observational
- 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 13 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants must meet eligibility criteria to be enrolled
Who may be able to join
- Diagnosis of type 1 diabetes for at least six months
- Fluent in spoken and written English
- Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
- Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period
Who cannot join
- Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation
- Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
- Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows
- Currently pregnant or plan to become pregnant during participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.
- Conditions
- Type 1 Diabetes
- Being tested
- Observational
- 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.
ObservationalOther
Participants will complete an in-person baseline study visit with fasting blood draw, medical and health history, anthropometrics and vital signs, and surveys. If participants are not currently using a CGM, one will be placed. The LifeData study mobile app will be installed on the participant's smartphone. Over the two-week home monitoring period, participants will be asked to wear the CGM and respond to EMA questions three times daily. After the end of the home monitoring period, a remote visit will be performed in which the CGM will be removed by the study participant at home; the study team will obtain all data available from the CGM and insulin pump (if available); and surveys will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Participants will complete the observational study over the 15 day study period Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecological Momentary Assessment (EMA) methods for measuring diabetes distress
Diabetes distress score via EMA
Measured: Home monitoring (days 1-14)
Ecological Momentary Assessment (EMA) methods for measuring anxiety
Anxiety score via EMA
Measured: Home monitoring (days 1-14)
Ecological Momentary Assessment (EMA) methods for measuring depression
Depression score via EMA
Measured: Home monitoring (days 1-14)
Secondary outcomes (2)
Glycemic Outcomes
Percent Time in range (70-180mg/dl), Percent time with low glucose readings (<70mg/dl), Percent time with high glucose (>180mg/dl)
Measured: Home monitoring (days 1-14)
Hemoglobin A1c
Hemoglobin A1c
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start7 Nov 2023
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Jennifer Iyengar, University of Michigan
- Investigators
- Jennifer Iyengar, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129994
- Sponsor's protocol ID
- HUM00234964
- Status last verified
- Sep 2025
- First submitted
- 30 Oct 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)
- ClinicalTrials.gov ID
- NCT06129994
- Acronym / sponsor ID
- HUM00234964
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 13 Nov 2023 (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.
This single site investigator-initiated prospective observational study will enroll up to 150 participants 13-26 years of age with Type 1 diabetes (T1D) and utilize ecological momentary assessment methods (EMA) to examine associations between different diabetes psychological domains (distress, anxiety, and depression) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: ObservationalParticipants will complete the observational study over the 15 day study period |
Who may qualify
- Ages
- 13 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants must meet eligibility criteria to be enrolled
Key inclusion criteria (4 listed)
- Diagnosis of type 1 diabetes for at least six months
- Fluent in spoken and written English
- Willing to carry around their mobile phone during the home monitoring period with daily access to cellular or WiFi connectivity
- Willing to wear a continuous glucose monitor (CGM) device during the home monitoring period
Key exclusion criteria (4 listed)
- Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation
- Skin conditions or diseases that would interfere with the CGM sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
- Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor or insulin pump removal) that cannot be scheduled around or accommodated within the study assessment windows
- Currently pregnant or plan to become pregnant during participation in the study
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 |
|---|---|---|
| ObservationalParticipants will complete an in-person baseline study visit with fasting blood draw, medical and health history, anthropometrics and vital signs, and surveys. If participants are not currently using a CGM, one will be placed. The LifeData study mobile app will be installed on the participant's smartphone. Over the two-week home monitoring period, participants will be asked to wear the CGM and respond to EMA questions three times daily. After the end of the home monitoring period, a remote visit will be performed in which the CGM will be removed by the study participant at home; the study team will obtain all data available from the CGM and insulin pump (if available); and surveys will be collected. | Other | Study Group |
Primary outcome
Ecological Momentary Assessment (EMA) methods for measuring diabetes distress
Time frame: Home monitoring (days 1-14)
Diabetes distress score via EMA
Ecological Momentary Assessment (EMA) methods for measuring anxiety
Time frame: Home monitoring (days 1-14)
Anxiety score via EMA
Ecological Momentary Assessment (EMA) methods for measuring depression
Time frame: Home monitoring (days 1-14)
Depression score via EMA
2 secondary outcomes
Glycemic Outcomes
Time frame: Home monitoring (days 1-14)
Hemoglobin A1c
Time frame: Baseline
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 6 Oct 2025.
- 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.
Jennifer Iyengar, MD principal investigator
University of Michigan
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 University of Michigan 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 4 inclusion and 4 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 6 Oct 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?
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?
Ecological Momentary Assessment (EMA) methods for measuring diabetes distress (time frame: Home monitoring (days 1-14)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2025.