NCT06883318

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

Active, enrolled Last updated 24 March 2025

What this trial tests

trial in Type 1 Diabetes Mellitus (T1DM) in 115,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 May 2019

Primary endpoint
31 December 2029

31 December 2029

Quick facts

Lead sponsor	Umeå University
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	115,000
Start date	8 May 2019
Primary completion	31 December 2029
Estimated completion	31 December 2029
Sites	1 location across Sweden

Conditions studied

• Type 1 Diabetes Mellitus (T1DM) — all drugs for Type 1 Diabetes Mellitus (T1DM) →
• End-Stage Renal Disease — all drugs for End-Stage Renal Disease →

Sponsor

Umeå University

Who can join

Eligibility, any sex, with Type 1 Diabetes Mellitus (T1DM) or End-Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.