Type 1 Diabetes MellitusNCT06464640
Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program
A study testing Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up" and E-book in people with Type 1 Diabetes Mellitus, run by Chang Gung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up" and E-book
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- # T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang-Gung University and Chang-Gung Memorial Hospital
Taoyuan, 33302
Yueh-Tao Chiang, PhD., +886-3-2118800 ext. 3866, nurs2004@gmail.com
Fu-Sung Lo, BSN, +886-3-281200 ext. 8969, lofusu@kimo.com
About this study
Official title: Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up", E-book
- Keywords
- type 1 diabetes, transition, podcast, self-regulation
- Medical subject headings
- Diabetes Mellitus, Type 1, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"Device
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.
E-bookDevice
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 an expert validity of 0.91, and reorganized it into an electronic health education manual titled \"Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes.\"
| Study group | Role | What they receive |
|---|---|---|
| podcast intervention | Experimental | The podcast will be used for intervention in the experimental group. Receives: Device: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up" |
| Ebook intervention | Sham comparator | Participants in the active control group will use E-book. Receives: Device: E-book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HbA1C (%) in participants
HbA1c from baseline, 3month and 6 months
Measured: Baseline and 3, 6months
percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants
the percentage of self-monitored blood glucose levels within the optimal range of 70-180 mg/dL
Measured: Baseline and 3, 6months
Number of Hyperglycemic Events in Participants
Number of events of each participant with blood sugar >200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed
Measured: Baseline and 3, 6months
Number Hypoglycemic Events in Participants
Number of events of each participant with blood sugar <60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed
Measured: Baseline and 3, 6months
Secondary outcomes (6)
Score of Diabetes Distress in Participants
Change in Diabetes Distress Scale score over time.Diabetes Distress Scale (DDS): The original scale was developed by Polonsky et al. (2005). The Chinese version consists of 18 items across four subscales. Items are scored on a 4-point Likert scale ranging from 1 (no distress) to 4 (severely distressed), with higher scores indicating more severe emotional distress. Cronbach's α and test-retest reliability values of the DDS were 0.89 and 0.81, respectively (Liu et al., 2010).
Measured: Baseline and 3, 6months
Score of Diabetes Self-Managemen in Participants
Perceived Diabetes Self-Management Scale (PDSMS):The original questionnaire was developed by Wallston et al. (2007). It consists of 8 items scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree),The translated questionnaire has content validity, Cronbach's α, and test-retest reliability values of 0.75, 0.93, and 0.97, respectively.
Measured: Baseline and 3, 6months
Score of Diabetes Self-care in Participants
Self-care Behavior Assessment Scale: This scale was developed by Wang (2010) to measure self-care behaviors of adolescents with T1D. A total of 39 items are scored on a 5-point Likert scale ranging from 1 (not achieved at all) to 5 (completely achieved). The total score ranges from 39 to 195, with higher scores indicating better self-care behaviors. Cronbach's α and the content validity index (CVI) value based on content rating by experts are 0.87 and 0.92, respectively.
Measured: Baseline and 3, 6months
Score of Diabetes Knowledge in Participants
Diabetes Knowledge Questionnaire (DKQ): The original questionnaire was developed by Garcia et al. (2001). The Chinese version comprises 24 items that are answered "Yes," "No" or "I don't know"; 1 point is awarded for each correct answer. The total score ranges from 0 to 24 points.reliability and Cronbach's α values of 0.78 and 0.89, respectively Hu et al.(2013)
Measured: Baseline and 3, 6months
Score of Interpersonal Distress in Participants
Analyze the score changes in the "Diabetes-Related Interpersonal Distress" subscale within the Diabetes Distress Scale (as previously mentioned in the Diabetes Distress Scale score ).
Measured: Baseline and 3, 6months
Score of Diabetes-Related Family Conflict in Participants
The Diabetes Family Conflict Scale-Revised (DFCS), revised by Hood et al. (2007), is used to assess family conflict and disagreements related to diabetes care in adolescents with T1D and their parents. The scale consists of 19 items and uses a 3-point scoring system: "Almost Never" scores 1 point, "Sometimes" scores 2 points, and "Almost Always" scores 3 points. Higher scores indicate more conflict. The DFCS has strong psychometric properties, with a Cronbach's α value of .95 for the adolescent version of the scale.
Measured: Baseline and 3, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: The Online Interactive Podcast Program\&#34;Living with Type 1 Diabetes to Grown-Up\&#34; will be used for intervention in the experimental group. active control group:E-book.According to the research results from the project Healthcare CEO 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 an expert validity of 0.91, and reorganized it into an electronic health education manual titled\&#34;Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes.\&#34;
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Yueh-Tao Chiang, Chang Gung University
- Investigators
- Yueh-Tao Chiang, PhD, Study director, Chang Gung UniversityFu-Sung Lo, BSN, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464640
- Sponsor's protocol ID
- T1dPodcastchanggungU
- Status last verified
- Oct 2024
- First submitted
- 13 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40978315
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06464640
- Acronym / sponsor ID
- T1dPodcastchanggungU
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes, transition, podcast, self-regulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
\&#34;Living with Type 1 Diabetes to Grown-Up\&#34;; 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 \&#34; Living with Type 1 Diabetes to GrownUp \&#34; 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Experimental group: The Online Interactive Podcast Program\&#34;Living with Type 1 Diabetes to Grown-Up\&#34; will be used for intervention in the experimental group. active control group:E-book.According to the research results from the project Healthcare CEO 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 an expert validity of 0.91, and reorganized it into an electronic health education manual titled\&#34;Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes.\&#34;
| Arm | Type | Receives |
|---|---|---|
| podcast intervention | Experimental | Device: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"The podcast will be used for intervention in the experimental group. |
| Ebook intervention | Sham comparator | Device: E-bookParticipants in the active control group will use E-book. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- # T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | podcast intervention |
| E-bookParticipants 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 an expert validity of 0.91, and reorganized it into an electronic health education manual titled \"Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes.\" | Device | Ebook intervention |
Primary outcome
Concentration of HbA1C (%) in participants
Time frame: Baseline and 3, 6months
HbA1c from baseline, 3month and 6 months
percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants
Time frame: Baseline and 3, 6months
the percentage of self-monitored blood glucose levels within the optimal range of 70-180 mg/dL
Number of Hyperglycemic Events in Participants
Time frame: Baseline and 3, 6months
Number of events of each participant with blood sugar >200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed
Number Hypoglycemic Events in Participants
Time frame: Baseline and 3, 6months
Number of events of each participant with blood sugar <60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40978315Chiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueh-Tao Chiang, PhD study director
Chang Gung University
Fu-Sung Lo, BSN study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up" and E-book in people with Type 1 Diabetes Mellitus, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Tao Chiang, PhD (+886-3-2118800 Ext. 3866, nurs2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of HbA1C (%) in participants (time frame: Baseline and 3, 6months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.