Constructive parental support and clarified responsibility to youth with type 1 diabetes starting continuous subcutaneous insulin infusio

Not Applicable

Completed

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN22444034
• Lead Sponsor: ppsala University (Sweden)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24354899 2017 qualitative study results in https://pubmed.ncbi.nlm.nih.gov/29225894/ (added 19/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-25
• Study Completion: 2017-12-31
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Children between the ages 12 and 17 years who are planned to start on Continuous Subcutaneous Insulin Infusion (CSII)
2. A diagnosis of type 1 diabetes for at least 1 year

Exclusion Criteria

1. If the teenager or the parent has difficulties to understand Swedish
2. Usage of continuous glucose monitoring (CGM) during study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured before start of CSII:<br> 1. HbA1c<br> 2. Length and weight<br> 3. Mean frequency of self-monitoring of blood glucose (SMBG)<br> 4. Check your health measure perceived physical and emotional health, social relations, general quality of life and impact of diabetes<br> 5. Disabkids is measuring generic health in children with chronic illness and have a specific diabetes module<br> 6. DFCS (Diabetes family conflict scale) is the most widely used measure of diabetes-specific family conflict<br> 7. Swe-DES 23 measures the psychosocial self-efficacy of people with diabetes<br> 8. Treatment satisfaction<br><br> Measure 6 and 12 month after start CSII:<br> 1. Same measures as before start CSII<br> 2. Frequency of missed bolus doses<br> 3. Usage of carbohydrate counting<br>

Secondary Outcome Measures

Name	Time	Method
Two weeks after completing the program 20 adolescents will be interviewed. This qualitative interview study will evaluate how adolescents perceive their parent support after taking part in the education program. The questions will be designed especially for this study. The interviews will be taped and transcribed and the analysis method will be qualitative content analysis.