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Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes, HbA1c, Self-management

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Education
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring type 1 diabetes mellitus, Steno Balance Card, group health education, blood sugar control, self-management

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 10-18years ord Type 1 DM.
  • Able to read and write Chinese.

Exclusion Criteria:

  • Communication and cognitive impairments.

Sites / Locations

  • Fangyi Lin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Steno Diabetes Dialogue Cards

Arm Description

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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.

Full Information

First Posted
May 24, 2022
Last Updated
June 5, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05394532
Brief Title
Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, HbA1c, Self-management
Keywords
type 1 diabetes mellitus, Steno Balance Card, group health education, blood sugar control, self-management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steno Diabetes Dialogue Cards
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Common Education
Primary Outcome Measure Information:
Title
HbA1c
Description
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 .
Time Frame
3 months
Secondary Outcome Measure Information:
Title
self management
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 10-18years ord Type 1 DM. Able to read and write Chinese. Exclusion Criteria: Communication and cognitive impairments.
Facility Information:
Facility Name
Fangyi Lin
City
Taipei city
State/Province
Beitou
ZIP/Postal Code
112303
Country
Taiwan

12. IPD Sharing Statement

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Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes

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