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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129994
• Other study ID #: HUM00234964
• Status: Recruiting
• Start date: November 7, 2023
• Est. completion date: September 2028

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Emily Dhadphale
• Phone: 734-936-6042
• Email: ehirschf[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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) in real-time on self-efficacy, self-management behaviors, and glycemic outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2028
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Observational
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ecological Momentary Assessment (EMA) methods for measuring diabetes distress	Diabetes distress score via EMA	Home monitoring (days 1-14)
Primary	Ecological Momentary Assessment (EMA) methods for measuring anxiety	Anxiety score via EMA	Home monitoring (days 1-14)
Primary	Ecological Momentary Assessment (EMA) methods for measuring depression	Depression score via EMA	Home monitoring (days 1-14)
Secondary	Glycemic Outcomes	Percent Time in range (70-180mg/dl), Percent time with low glucose readings (<70mg/dl), Percent time with high glucose (>180mg/dl)	Home monitoring (days 1-14)
Secondary	Hemoglobin A1c	Hemoglobin A1c	Baseline