REAL-T Study: RCT of diabetes management intervention, 2019-2025

Name	File Type	Size	Last Modified
Assessments			03/19/2026 03:32:PM
Codebook			03/19/2026 03:33:PM
Consents			03/19/2026 03:34:PM
Data			03/19/2026 03:35:PM
Data Use Agreement			03/19/2026 03:37:PM

Project Citation:

Pyatak, Elizabeth. REAL-T Study: RCT of diabetes management intervention, 2019-2025. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2026-04-29. https://doi.org/10.3886/E240494V1

Project Description

Summary: Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study sought to address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D). The purpose of REAL-T was threefold: (1) to evaluate the efficacy of the REAL intervention as administered via telehealth (REAL-T), in improving glycemic control (HbA1c) and psychosocial outcomes; (2) to examine the extent to which beneficial intervention effects are retained over a 6-month follow-up period; and (3) to investigate the mediating mechanisms responsible for the intervention’s effects. We conducted a large-scale RCT (n=209) to compare REAL-T to usual care in improving glycemic control (HbA1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we performed health economic analyses to determine the extent to which REAL-T was cost-effective or produced cost savings.

Funding Sources: NIH/NIDDK (R01DK116719)

Scope of Project

Subject Terms: diabetes; occupational therapy; self management; autonomy; self efficacy; glycemic control; psychological wellbeing; habit

Geographic Coverage: Oregon, Texas, Colorado, California, Washington

Time Period(s): 2019 – 2023

Collection Date(s): 10/2019 – 11/2023

Universe: English- or Spanish-speaking adults aged 18-30 years at time of enrollment with type 1 diabetes for at least 12 months, and living in California, Oregon, Colorado, Texas, or Washington.

Data Type(s): clinical data; experimental data; medical records

Methodology

Response Rate: A total of 851 individuals were assessed for eligibility, and 209 were randomized to either the intervention group (n = 104) or the control group (n = 105).

At 6 months, 188 of the 209 randomized participants (89.9%) at least partially completed follow-up data collection. Twenty-one participants did not complete 6-month follow-up: 9 were lost to follow-up, 10 withdrew at their request, and 2 were discontinued by the study team due to pregnancy.

At 12 months, 171 of the 209 randomized participants (81.8%) at least partially completed follow-up data collection. Thirty-eight participants did not complete 12-month follow-up: 19 were lost to follow-up, 14 withdrew at their request, 4 were discontinued due to pregnancy, and 1 did not complete testing due to illness (COVID-19).

Sampling:

The study was a two-arm parallel-group randomized controlled trial. Participants were assigned in a 1:1 ratio to either the intervention group or a usual care control group, stratified by recruitment source (clinic vs. social media) using random block sizes.

Data Source:

Participant self-report questionnaires
Standardized instruments
Wearable device data
Laboratory tests
Medical records / EHR
Intervention session records
Clinical assessments

Collection Mode(s): on-site questionnaire; other; telephone interview; web-based survey

Scales:

Audit of Diabetes Dependent Quality of Life (ADDQoL)
Diabetes Distress Scale (DDS)
Diabetes Empowerment Scale - Short Form (DES-SF)
12-item MOS Short-form Health Survey version 2 (MOS SF12v2)
Diabetes Self-Management Questionnaire - Revised (DSMQ-R)
Self-Reported Behavioural Automaticity Index (SRBAI)
Treatment Self-Regulation Questionnaire (TSRQ)

Unit(s) of Observation: Individuals

Geographic Unit: State

Related Publications

Release of this data has been delayed until 12/31/2027 at the request of the depositor.

Published Versions

V1 [2026-04-29]

Export Metadata

Dublin Core

DDI 2.5

Report a Problem

Found a serious problem with the data, such as disclosure risk or copyrighted content? Let us know.

This material is distributed exactly as received from the data depositor. As of April 2026, depositors are required to submit study materials in accessible formats. ICPSR has not reviewed, checked, or processed this material. For additional information about the study, please contact the investigator(s) directly. If you have questions about the accessibility of materials distributed by ICPSR or require further assistance, please visit ICPSR's Accessibility Center.