NCT06563401

Brief Summary

Scarce evidence is available for prognosis in adult-onset type 1 diabetes (T1D). The aim of this study is to investigate the risk of all-cause mortality, cause-specific mortality, and incident CVD in adult-onset T1D, as compared to type 2 diabetes with comparable age at diagnosis and population controls. We will explore potential modifiable factors including lifestyle and clinical characteristics that contribute to T1D prognosis. In addition, we will estimate the life expectancy associated with different age at T1D diagnosis as compared to population controls. This study will be based on people with diabetes recorded in Swedish National Diabetes Registers, with linkages to other nationwide registers to retrieve data on lifestyle factors, biomarkers, treatment and outcome information.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

August 19, 2024

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality and vascular outcomes

    all-cause mortality, cause-specific mortality, and MACE

    2001-2022

Study Arms (3)

population controls

Randomly sampled diabetes controls from the general Swedish population

Other: prognosis of adult-onset t1d

adult-onset T1D

people who developed T1D as adults 2001-2020 in Sweden

Other: prognosis of adult-onset t1d

T2D

people who developed T2D 2001-2020 in Sweden

Other: prognosis of adult-onset t1d

Interventions

We are comparing mortality and vascular outcomes in adult-onset T1D to T2D and diabetes-free people

T2Dadult-onset T1Dpopulation controls

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the source population was everyone born 2001-2020

You may qualify if:

  • people with adult-onset (≥18 years) T1D diagnosed in 2001-2020 from the National Diabetes Register
  • all T2D cases diagnosed at age ≥18 years in 2001-2020 recorded in the National Diabetes Register
  • Everyone with T1D was matched by age, sex, and county to 50 population controls from the Total Population Register.

You may not qualify if:

  • To avoid diabetes secondary to pancreatic cancer, we excluded people diagnosed with cancer in the digestive system 1 year prior to diabetes diagnosis and with pancreatic cancer as the underlying cause of death.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institute

Stockholm, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sofia Carlsson, phd

    sofia carlsson, senior lecturer, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Carlsson, phd

CONTACT

Yuxia Wei, phd

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
22 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior lecturer

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 20, 2024

Study Start

January 1, 2024

Primary Completion

May 31, 2025

Study Completion

July 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Our data is register-based data that is pseudonymised and thus subject to General Data Protection Regulation (GDPR) and cannot be shared openly

Locations