Type 1 Diabetes Mellitus (T1DM)NCT06883318
Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden
An observational study of Type 1 Diabetes Mellitus (T1DM) and End-Stage Renal Disease, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM), End-Stage Renal Disease
- How many people
- 115,000 participants
- Where
- 1 siteSweden
- Study dates
- 8 May 2019to 31 Dec 2029
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Type 1 diabetes, Childhood-onset, Risk factors, Complications, Socioeconomic conditions
- Medical subject headings
- Diabetes Mellitus, Type 1, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases with childhood-onset type 1 diabetes | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 1
Incidence of type 1 diabetes in individuals below 15 years of age in Sweden
Measured: From the inception of the data base in July 1977 through 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start8 May 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115,000 participants (actual)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Lund University, The Swedish Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883318
- Sponsor's protocol ID
- 2019-02492
- Other IDs
- 2019
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden - Longitudinal Register Based Studies
- ClinicalTrials.gov ID
- NCT06883318
- Acronym / sponsor ID
- 2019-02492
- Keywords
- Type 1 diabetes, Childhood-onset, Risk factors, Complications, Socioeconomic conditions
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 115,000 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Uppsala University, Lund University, The Swedish Research Council
- Study start
- 8 May 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with childhood-onset type 1 diabetes | – | – |
| Healthy controls | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of type 1
Time frame: From the inception of the data base in July 1977 through 2029
Incidence of type 1 diabetes in individuals below 15 years of age in Sweden
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus (T1DM) and End-Stage Renal Disease, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of type 1 (time frame: From the inception of the data base in July 1977 through 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.