Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program

Official title

Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial

Overview

The present study aims to evaluate the intervention effectiveness of the Online Interactive Podcast Program"Living with Type 1 Diabetes to Grown-Up"in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Detailed description

Individuals aged 16-25 with Type 1 Diabetes (T1D) face significant transitional challenges in their lives, with an increased risk of worsening disease management. Addressing these challenges, an interactive podcast program,

\"Living with Type 1 Diabetes to Grown-Up\"; is being developed with a one-year grant from the National Science and Technology Council. This continued project will span three years, employing a mixed-method research design for evaluation. Participants will be recruited from pediatric endocrinology and genetics clinics and wards across two medical centers in Northern Taiwan. In line with recommendations from prior reviewers, the study will incorporate a two-phased approach: the first phase is a quantitative study, structured around transitional theory and self-regulation theory using PRIDE steps. It adopts a double-blinded, randomized controlled experimental method with data collector and sham treatment participants blinded. Subjects will be randomly assigned to either the experimental group (N=44) or the active control group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance, confidence in self-management, self-care behaviors, diabetes knowledge, interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods. In the subsequent qualitative phase, 15-20 cases from the experimental group will be selected for in-depth interviews to evaluate the impact of the \" Living with Type 1 Diabetes to GrownUp \" interactive podcast program.

The outcomes of this research are anticipated to contribute significantly to the clinical management and technological intervention strategies for T1D adolescents in their transitional phase to adulthood.

Interventions

• Device Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"
  The podcast content was designed based on the results of previous research.Subjects will be randomly assigned to either the experimental group (N=44) or the comparison group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance,confidence in self-management, self-care behaviors, diabetes knowledge,interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods.
• Device E-book
  Participants in the active control group will use Ebook.According to the research results from the project leader\'s app effectiveness evaluation (Chiang, 2020-2022), the e-book did not show significant effects on blood sugar control, disease management confidence, self-care behaviors, disease-related knowledge, or interpersonal distress. Therefore, the active control group received a sham treatment in the form of an e-book. The research team extracted content from the CEO APP e-book, with a

Primary outcome measures

• Concentration of HbA1C (%) in participants [Time frame: Baseline and 3, 6months]
• percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants [Time frame: Baseline and 3, 6months]
• Number of Hyperglycemic Events in Participants [Time frame: Baseline and 3, 6months]
• Number Hypoglycemic Events in Participants [Time frame: Baseline and 3, 6months]

Secondary outcome measures (6)

• Score of Diabetes Distress in Participants [Time frame: Baseline and 3, 6months]
• Score of Diabetes Self-Managemen in Participants [Time frame: Baseline and 3, 6months]
• Score of Diabetes Self-care in Participants [Time frame: Baseline and 3, 6months]
• Score of Diabetes Knowledge in Participants [Time frame: Baseline and 3, 6months]
• Score of Interpersonal Distress in Participants [Time frame: Baseline and 3, 6months]
• Score of Diabetes-Related Family Conflict in Participants [Time frame: Baseline and 3, 6months]

Eligibility criteria

Inclusion criteria

• a confirmed diagnosis of T1D by an endocrinologist before the age of 16 and a disease duration of >6months
• patients aged 16-25 years
• mean HbA1C level ≥7.5% one year before inclusion
• ability to communicate in Chinese or Mandarin
• patients who own smartphones with internet access
• patients who agreed to voice recording during a session explaining the treatment process
• patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.

Exclusion criteria

\# T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Taiwan · 1 center

• Chang-Gung University and Chang-Gung Memorial Hospital — Taoyuan

Publications

• Chiang YT, Lo FS, Yu HY, Chen CW, Moons P. Efficacy of the Online Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-Arm Randomized Controlled Trial Protocol. J Diabetes Res. 2025 Sep 13;2025:4866975. doi: 10.1155/jdr/4866975. eCollection 2025. PMID 40978315

Identifiers

NCT: NCT06464640 · T1dPodcastchanggungU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗