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EMPoWER Study: Strengths-based Intervention for Youth with Type 1 Diabetes

The EMPoWER Study is looking at a program called "Type 1 Doing Well" (T1DW) for young people aged 10-13 with Type 1 Diabetes. This program uses a mobile app for both parents and youth to focus on what the youth does well with their diabetes, set family goals, and have weekly meetings. The study will compare this app-based program to receiving general diabetes information and resources. Researchers want to see if the T1DW program can improve blood sugar control (measured by HbA1c and time-in-range), how well participants stick to their diabetes management plan, and their overall quality of life. You may be eligible if you have Type 1 Diabetes, are 10-13 years old, and your HbA1c has been 7.5% or higher in the past year.

Study design
This is a randomized clinical trial aiming to enroll 250 participants. Participants will be randomly assigned to either the "Type 1 Doing Well" program or a program providing diabetes-related information.
What's involved
Participants will provide data through questionnaires, A1c tests, and medical/device data at baseline, 3, 6, and 12 months. The main intervention period lasts for 6 months, and there will be an orientation session and a feedback interview.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the study, with data collected at baseline, 3, 6, and 12 months.

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NCT06014879

EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

Recruiting
NAAges 10–99InterventionalTreatment
Baylor College of Medicine
~250 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Type 1 Doing Well (T1DW) ProgramDiabetes-Related Information and Resources Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demographic and Medical Information Questionnaire
Measured over Baseline
+4 more outcomes measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Marisa Hilliard, PhD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Marisa Hilliard, PhD
[email protected]
832-824-7209
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

type 1 diabetes diagnosis per ADA criteria for at least 6 months,
age 10 to 13 years at consent,
English or Spanish fluency,
At least one hemoglobin A1c value ≥ 7.5 % (percent) within the past 12 months (changed from ≥8.0% in March 2026)
Patient at one of the participating study sites
Age at least 18 years old at time of consent,
English or Spanish fluency,
Consistent access to a mobile phone that has texting capabilities and a device with internet access
self-reported type 1 diabetes diagnosis for ≥ 1 year,
age 14-17 at consent,
English fluency,
living in the United States

Exclusion

a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
a major serious psychological or psychiatric condition,
a major serious developmental condition that would interfere with capacity for informed assent or participation or that would confound outcomes
a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
a major serious psychological or psychiatric condition,
a major serious developmental condition that would interfere with capacity for informed consent or participation or that would confound outcomes
Plans to move diabetes care out of participating hospital site within next 6 months,
Legal guardianship of the youth with diabetes being unclear at the time of screening or recruitment,
Study team learning of other involvement with the legal system during screening or recruitment
major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation,
major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis).

What this trial measures

  • Demographic and Medical Information QuestionnaireBaseline

    Only demographic information and limited diabetes treatment information will be collected about participants in the teen videos portion of this study. Participants will complete a brief questionnaire developed by the study team, which will request self-reported information about participant demographics (e.g., race, ethnicity, gender) and medical information (e.g., time since diabetes diagnosis, current treatments).

  • Glycemic Control - HbA1cBaseline, 6 months, 12 months

    Point of care HbA1c values documented by the medical team at each clinic visit will be collected from the electronic health record, to assess change in glycemic outcomes. Youth will be asked to complete a home dry blood spot A1c kit at three study timepoints unless an A1c value is documented in the electronic health record within the required timeframe. The study team will mail youth a home kit with instructions, all necessary materials to collect the sample, and a pre-paid mailer to ship it back. Higher HbA1c indicates higher average blood glucose values over the previous 2-3 months, which represents poorer glycemic control.

  • Glycemic Control - time-in-rangeBaseline, 3 months, 6 months, and 12 months

    When available for youth who use a continuous glucose monitor (CGM), 14 days' of CGM data will be downloaded at each time point by the study teams to calculate glucose time-in-range as an additional index of glycemic control. Higher time-in-range is an indicator of better glycemic control.

  • Adherence - Self-Care Inventory 2 (SCI-2)Baseline, 3 months, 6 months, and 12 months

    Parents and youth will complete the Self-Care Inventory 2 (SCI-2) Short Form. The form was adapted/shortened by the study team with permission from the original author, with validation paper forthcoming. Higher scores indicate higher adherence/more engagement in diabetes self-management behaviors.

  • Health-Related Quality of Life (HRQOL)Baseline, 3 months, 6 months, and 12 months

    Parents and youth willcomplete the age- and respondent-appropriate version of the Type 1 Diabetes and Life (T1DAL) measure. Psychometric data regarding the validity and reliability of the pediatric, adult, and parent/partner versions of the T1DAL are published. Total scores are on a 100-point scale, with higher scores indicating better quality of life.