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

NCT ID: NCT06883318

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

115000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-08

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus (T1DM) End-Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases with childhood-onset type 1 diabetes

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Clinical Sciences, Umeå University

Umeå, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2019-02492

Identifier Type: -

Identifier Source: org_study_id

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