Clinical trial NCT06883318: Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden
Official title: Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden - Longitudinal Register Based Studies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 1 Diabetes Mellitus (T1DM)
End-Stage Renal Disease
Keywords: Type 1 diabetes
Childhood-onset
Risk factors
Complications
Socioeconomic conditions
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Lund University
name: The Swedish Research Council
First posted: 2025-03-19
Enrollment: 115000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Swedish Childhood Diabetes Register (SCDR) is based on collaboration with all paediatric clinics in Sweden; from 1977 until 2010 the clinics helped with data collection. Since 2011 the National Board of Health provides new incident data from insulin pre-scriptions using the Prescribed Drug register (PDR). It recruits all cases of type 1 diabetes in children below 15 years. To each case four controls have been assigned through Statistics Sweden.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of type 1
timeFrame: From the inception of the data base in July 1977 through 2029
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Clinical Sciences, Umeå University
Study officials:
References: