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

Constructive parental support and clarified responsibility to youth with type 1 diabetes starting continuous subcutaneous insulin infusion: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22444034
Enrollment
80
Registered
2013-01-25
Start date
2013-01-01
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

Participants will be randomized to either intervention (n=40) or control group (n=40) when they have decided to start on CSII. All youth will receive standard start training, including technical skill

Sponsors

Uppsala University (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026