Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden

Active, not recruiting

• Conditions: Type 1 Diabetes Mellitus (T1DM); End-Stage Renal Disease

• Registration Number: NCT06883318
• Lead Sponsor: Umeå University

Brief Summary

The researchers study time trends of childhood-onset type 1 diabetes and its most serious complication, end-stage renal disease. They further analyse physical, psychological and socio-economic long-term effects on patients and families to identify potentially preventive factors in a population perspective. The researchers investigate the economic burden of disease and study and improve statistical methods for case-control data. The projects use a longitudinal nationwide database involving about 23 000 childhood-onset diabetes cases with maximum follow-up of 48 years and for each case 4 matched controls. The Swedish Childhood Diabetes Register is linked to a number of official, Swedish registers: the Renal register, the Cause of Death register, the National Patient register, the Prescribed Drugs register, the Cancer register and the Integrated Database for Labour Market Research. The researchers use GAM modelling for time trend analyses, standard case-control/cohort analyses, Cox regression for life table analyses, linear fixed effect probability for career development and propensity score models for confounding. The project group is multidisciplinary and involves experts in paediatrics, nephrology, epidemiology, health economics and statistics. This unique database and team continues to yield population-based new knowledge on the consequences of this increasingly common chronic childhood-onset disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-08
• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 115000

Inclusion Criteria

• Two prescriptions of insulin in the Prescribed Drug register.
• Age below 15 years of age. Controls are of the same age and born in the same municipality as the cases.

Exclusion Criteria

• No

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of type 1	From the inception of the data base in July 1977 through 2029	Incidence of type 1 diabetes in individuals below 15 years of age in Sweden

Trial Locations

Locations (1)

Department of Clinical Sciences, Umeå University; 🇸🇪 Umeå, Sweden