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

Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden - Longitudinal Register Based Studies

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.

Study Overview

• Status: Active, not recruiting
• Conditions: End-Stage Renal Disease; Type 1 Diabetes Mellitus (T1DM)

• Study Type: Observational
• Enrollment (Actual): 115000

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden, 901 87
    • Department of Clinical Sciences, Umeå University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy controls
Cases with childhood-onset type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of type 1	Incidence of type 1 diabetes in individuals below 15 years of age in Sweden	From the inception of the data base in July 1977 through 2029

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Lund University; Uppsala University; The Swedish Research Council

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Risk factors; Complications; Childhood-onset; Socioeconomic conditions
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 1; Kidney Failure, Chronic
• Other Study ID Numbers: 2019-02492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data come from official Swedish registers through Statistics Sweden and National Board of Health and Welfare where researchers have access to pseudonymonised information. The ethical permit does not allow sharing of data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No