Type 1 Diabetes MellitusDIPPNCT03269084
Type 1 Diabetes Prediction and Prevention (DIPP) Study
An observational study of Type 1 Diabetes Mellitus, run by Riitta Veijola at 3 sites in Finland.
Trial summary
The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 17,000 participants
- Where
- 3 sitesFinland
- Study dates
- 7 Nov 1994to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Since November 1994 the Finnish Type 1 Diabetes Prediction and Prevention (DIPP) Study has screened 206,707 newborns for HLA-conferred genetic susceptibility for T1D (Figure 1., data as of March 2015). A total of 16,193 children have started clinical follow-up with regular study visits and systematic collection of longitudinal blood and stool samples. Altogether more than 1000 children have seroconverted to positivity for multiple islet autoantibodies (ICA included). A total of 461 children and adolescents have progressed to clinical T1D with DIPP follow-up from birth until diagnosis. Currently there are 7158 children between 3 months and 15 years of age taking part in the DIPP Study follow-up.
Who may be able to join
- Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland
Who cannot join
- Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes
Trial locations and contacts
3 sites in 1 country.
Finland3 sites, 3 recruiting
- Recruiting
University of Oulu and Oulu University Hospital
Oulu, 90029
Riitta Veijola, MD, +358 8 3155129, riitta.veijola@oulu.fi
Riitta Veijola, MD
- Recruiting
University of Tampere and Tampere University Hospital
Tampere, 33520
Mikael Knip, MD, mikael.knip@helsinki.fi
Mikael Knip, MD
- Recruiting
University of Turku and Turku University Hospital
Turku, 20520
Jorma Toppari, MD, jorma.toppari@utu.fi
Jorma Toppari, MD
About this study
The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment.
Read the detailed description
Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until T1D is diagnosed. Clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of T1D are measured. Children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will develop T1D and 60% of future T1D cases will be reached by the current screening and follow-up strategy.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- No intervention. DIPP is an observational study.
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. DIPP is an observational study.Other
| Study group | Role | What they receive |
|---|---|---|
| Children at HLA-conferred risk for T1D | Not described Receives: Other: No intervention. DIPP is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity for at least one islet autoantibody
ICA, IAA, GADA, IA-2A or ZnT8A
Measured: December 31, 2021
Clinical diagnosis of type 1 diabetes
Hyperglycemia as defined by WHO
Measured: December 31, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start7 Nov 1994
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riitta Veijola
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, University of Turku, Turku University Hospital, Tampere University, Tampere University Hospital, Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor-investigator, Riitta Veijola, University of Oulu
- Investigators
- Riitta Veijola, MD PhD, Principal investigator, University of Oulu, Oulu University HospitalMikael Knip, MD PhD, Principal investigator, University of Helsinki, Tampere University HospitalJorma Toppari, MD PhD, Principal investigator, University of Turku, Turku University HospitalKalle Kurppa, MD PhD, Principal investigator, Tampere UniversityHeikki Hyöty, MD PhD, Principal investigator, Tampere UniversityJohanna Lempainen, MD PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269084
- Sponsor's protocol ID
- 1-SRA-2016-342-M-R
- Acronym
- DIPP
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2017
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kyronniemi A, Valtanen T, Koskenniemi J, Vahasalo P, Harkonen T, Ilonen J, Toppari J, Knip M, Veijola R. Extremely Early Appearance of Islet Autoantibodies in Genetically Susceptible Children. Pediatr Diabetes. 2023 Dec 11;2023:9973135. doi: 10.1155/2023/9973135. eCollection 2023.
PubMed 40303239
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Prediction and Prevention (DIPP) Study
- ClinicalTrials.gov ID
- NCT03269084
- Acronym / sponsor ID
- DIPP / 1-SRA-2016-342-M-R
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- Riitta VeijolaUniversity, hospital or other
- Collaborators
- Oulu University Hospital, University of Turku, Turku University Hospital, Tampere University, Tampere University Hospital, Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 7 Nov 1994 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Aug 2017 (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 Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment.
Detailed description
Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until T1D is diagnosed. Clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of T1D are measured. Children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will develop T1D and 60% of future T1D cases will be reached by the current screening and follow-up strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children at HLA-conferred risk for T1D | – | Other: No intervention. DIPP is an observational study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Since November 1994 the Finnish Type 1 Diabetes Prediction and Prevention (DIPP) Study has screened 206,707 newborns for HLA-conferred genetic susceptibility for T1D (Figure 1., data as of March 2015). A total of 16,193 children have started clinical follow-up with regular study visits and systematic collection of longitudinal blood and stool samples. Altogether more than 1000 children have seroconverted to positivity for multiple islet autoantibodies (ICA included). A total of 461 children and adolescents have progressed to clinical T1D with DIPP follow-up from birth until diagnosis. Currently there are 7158 children between 3 months and 15 years of age taking part in the DIPP Study follow-up.
Key inclusion criteria (1 listed)
- Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland
Key exclusion criteria (1 listed)
- Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. DIPP is an observational study. | Other | Children at HLA-conferred risk for T1D |
Primary outcome
Positivity for at least one islet autoantibody
Time frame: December 31, 2021
ICA, IAA, GADA, IA-2A or ZnT8A
Clinical diagnosis of type 1 diabetes
Time frame: December 31, 2021
Hyperglycemia as defined by WHO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 40303239Kyronniemi A, Valtanen T, Koskenniemi J, Vahasalo P, Harkonen T, Ilonen J, Toppari J, Knip M, Veijola R. Extremely Early Appearance of Islet Autoantibodies in Genetically Susceptible Children. Pediatr Diabetes. 2023 Dec 11;2023:9973135. doi: 10.1155/2023/9973135. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Riitta Veijola, MD PhD principal investigator
University of Oulu, Oulu University Hospital
Mikael Knip, MD PhD principal investigator
University of Helsinki, Tampere University Hospital
Jorma Toppari, MD PhD principal investigator
University of Turku, Turku University Hospital
3 sites 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, run by Riitta Veijola at 3 sites in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riitta Veijola, MD PhD (+358407422328, riitta.veijola@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity for at least one islet autoantibody (time frame: December 31, 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269084, which also lists 1 linked publication.
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 7 Apr 2023.