Type 1 DiabetesNCT05394532
Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
A study testing Education in people with Type 1 Diabetes and HbA1c, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, HbA1c, Self-management
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2020to 12 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 10-18years ord Type 1 DM.
- Able to read and write Chinese.
Who cannot join
- Communication and cognitive impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Steno Diabetes Dialogue Cards Teaching Instrument on Diabetes in Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The main symptoms are the three mores （eat more, drink more and urinate more）, weight loss, urine sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1 is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic Control. If the DKA happened, the patients need to be rescued in the ICU. is because it sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens when the boold sugar is not well controlled.
- Conditions
- Type 1 Diabetes, HbA1c, Self-management
- Being tested
- Education
- Keywords
- type 1 diabetes mellitus, Steno Balance Card, group health education, blood sugar control, self-management
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Common Education
| Study group | Role | What they receive |
|---|---|---|
| Steno Diabetes Dialogue Cards | Experimental | Not described Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The subjects were 83 adolescents diagnosed with type 1 diabetes mellitus. The experiment group intervened with the Steno Balance Card method was better than the control group which received only general health education in terms of blood sugar control after 3 months .
Measured: 3 months
Secondary outcomes (1)
self management
There was in scores between the experimental and the control groups three months after intervention which means both health education methods improved the level of self-management in patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start2 Oct 2020
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin, I-Hsiang, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394532
- Sponsor's protocol ID
- IHLin
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steno Diabetes Dialogue Cards Teaching Instrument on Diabetes in Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05394532
- Acronym / sponsor ID
- IHLin
- Conditions
- Type 1 Diabetes, HbA1c, Self-management
- Keywords
- type 1 diabetes mellitus, Steno Balance Card, group health education, blood sugar control, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 27 May 2022 (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 Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The main symptoms are the three mores （eat more, drink more and urinate more）, weight loss, urine sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1 is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic Control. If the DKA happened, the patients need to be rescued in the ICU. is because it sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens when the boold sugar is not well controlled.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Steno Diabetes Dialogue Cards | Experimental | Other: Education |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 10-18years ord Type 1 DM.
- Able to read and write Chinese.
Key exclusion criteria (1 listed)
- Communication and cognitive impairments.
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 |
|---|---|---|
| EducationCommon Education | Other | Steno Diabetes Dialogue Cards |
Primary outcome
HbA1c
Time frame: 3 months
The subjects were 83 adolescents diagnosed with type 1 diabetes mellitus. The experiment group intervened with the Steno Balance Card method was better than the control group which received only general health education in terms of blood sugar control after 3 months .
1 secondary outcome
self management
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Type 1 Diabetes and HbA1c, run by National Taipei University of Nursing and Health Sciences 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 2 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: finished, as of the sponsor's last update on 7 Jun 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022.