Skip to main content
OpenTrials
Completed

NCT Number: NCT06129994

Ecological Momentary Assessment Study of Adolescents and Young Adults With Type 1 Diabetes (EMA-T1D)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–26 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Observational

Other

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.

Primary outcomes

  1. Ecological Momentary Assessment (EMA) methods for measuring diabetes distress

    Time frame: Home monitoring (days 1-14)

    Diabetes distress score via EMA

  2. Ecological Momentary Assessment (EMA) methods for measuring anxiety

    Time frame: Home monitoring (days 1-14)

    Anxiety score via EMA

  3. Ecological Momentary Assessment (EMA) methods for measuring depression

    Time frame: Home monitoring (days 1-14)

    Depression score via EMA

Secondary outcomes

  1. Glycemic Outcomes

    Time frame: Home monitoring (days 1-14)

    Percent Time in range (70-180mg/dl), Percent time with low glucose readings (<70mg/dl), Percent time with high glucose (>180mg/dl)

  2. Hemoglobin A1c

    Time frame: Baseline

    Hemoglobin A1c

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.