NCT05394532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

May 24, 2022

Last Update Submit

June 5, 2022

Conditions

Keywords

type 1 diabetes mellitusSteno Balance Cardgroup health educationblood sugar controlself-management

Outcome Measures

Primary Outcomes (1)

  • 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 .

    3 months

Secondary Outcomes (1)

  • self management

    3 months

Study Arms (1)

Steno Diabetes Dialogue Cards

EXPERIMENTAL
Other: Education

Interventions

Common Education

Steno Diabetes Dialogue Cards

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Communication and cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fangyi Lin

Taipei, Beitou, 112303, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

October 2, 2020

Primary Completion

December 12, 2021

Study Completion

December 12, 2021

Last Updated

June 7, 2022

Record last verified: 2022-06

Locations