Type 1 Diabetes MellitusiT1DNCT06676566
Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus and Stage 2 Type 1 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
The aim is to investigate whether screening for islet autoantibodies, regular follow-up, and increased knowledge in families about the progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an earlier diagnosis of stage 3 type… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Stage 2 Type 1 Diabetes, Stage 1 Type 1 Diabetes
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 14 Oct 2024to 1 Oct 2034
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who have been screened for genetic risk for type 1 diabetes at birth in the ASTR1D study and other children who have been screened for either genetic risk or islet autoantibodies in other studies.
Who may be able to join
- Children 0 -10 years with high or moderate genetic risk of type 1 diabetes, measured by a combined analysis of HLA and non-HLA SNPs. Moderate genetic risk is defined as 8-10% risk of developing multiple islet autoantibodies before 6 years of age, and high genetic risk as over 10% risk of developing multiple islet autoantibodies before 6 years of age.
- Children 0-18 years of age screened in other research studies or tested at a clinical site and found to have a single autoantibody (before stage 1 type 1 diabetes) or multiple islet autoantibodies without or with impaired glucose tolerance (stage 1 or 2 type 1 diabetes, respectively).
- Children will be invited to participate in the current study if they have moderate or high genetic risk and 1) have participated in a prevention trial but have dropped out or the trial has ended 2) are not willing to participate in prevention trial.
- Children screened and found to be positive for islet autoantibodies in other studies (TEDDY, TrialNet, Innodia etc) or in clinical settings but which have not progressed to stage 3 type 1 diabetes can also be invited to participate in the current study.
Who cannot join
- Stage 3 type 1 diabetes
- Currently participating in a prevention study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim is to investigate whether screening for islet autoantibodies, regular follow-up, and increased knowledge in families about the progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an earlier diagnosis of stage 3 type 1 diabetes compared to no screening or follow-up.
Risk factors studied in relation to disease progression are the impact of higher-than-average weight gain, insulin resistance, and physical activity, both individually and in combination, on the risk of developing autoantibodies and disease progression.
Read more
An alternative diagnostic method, continuous glucose monitoring (CGM), will be evaluated for its for usefullness in early diagnosis of stage 2 and 3 type 1 diabetes as alternatives to oral glucose tolerance tests.
Another aim is to investigate the psychological impact of being aware that the children are at a higher risk of type 1 diabetes.
When a child in the study develops stage 3 type 1 diabetes, the psychological impact and metabolic control during the first five years after diagnosis will be compared to children not followed before the diagnosis.
- Conditions
- Type 1 Diabetes Mellitus, Stage 2 Type 1 Diabetes, Stage 1 Type 1 Diabetes, Stage 3 Type 1 Diabetes
- Keywords
- type 1 diabetes, genetic risk, islet autoantibodies, staging of type 1 diabetes, islet autoimmunity, children, follow-up, autoantibody screening
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Genetic risk without islet autoantibodies | This group has more than 10% risk of early onset of islet autoimmunity and can come to visits at 2, 6 and 10 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. The child will wear an accelerometer for one week after each visit. | |
| Genetic risk with 1 islet autoantibody | This group will be followed annually up to diabetes diagnosis or to 18 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. The child will wear an accelerometer for one week after each visit. | |
| Genetic risk with multiple islet autoantibodies | This group will come to visits every three months up to diagnosis or 18 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. An OGTT will be performed at some of the visits. The child will wear an accelerometer and a CGM for one week after each visit. | |
| Children with stage 3 type 1 diabetes who have taken part in the study before diagnosis | Annual visits at the study center will continue for the first 5 years after diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diabetes diagnosis, measured as HbA1c, symptoms, incidence of DKA
Investigate if screening for islet autoantibodies, regular follow-up and increased knowledge in the families regarding progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an early diagnosis of stage 3 type 1 diabetes, measured by HbA1c and symptoms, and prevents DKA as compared to no screening or follow-up.
The hypothesis is that screening and follow-up ensures an early diagnosis with no/few symptoms and prevents DKA.
Measured: From enrollment to a maximum of 10 years follow-up
Growth in relation to development of 1 islet autoantibody and progression to multiple islet autoantibodies and clinical type 1 diabetes
Investigate the impact of higher-than-average weight gain (SDS body weight in kg) on the risk of developing islet autoantibodies, progressing from one to several autoantibodies (stage 1 or 2 type 1 diabetes) and to progression to clinical type 1 diabetes (stage 3 type 1 diabetes). The hypothesis is that higher than average weight gain increase the risk of islet autoimmunity.
Measured: From enrollement to a maximum of 10 years follow up.
Insulin resistance in relation to development of islet autoantibodies, progression to multiple islet autoantibodies and clinical type 1 diabetes
Investigate the impact insulin resistance, measured as HOMA-IR on the risk of developing islet autoantibodies, progression from a single islet autoantibody to multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) and to stage 3 clinical type 1 diabetes. The hypothesis is that higher insulin resistance, measured as HOMA-IR, increase the risk of developing islet autoantibodies and the rate of progression to multiple islet autoantibodies and stage 3 type 1 diabetes.
Measured: From enrollment to a maximum of 10 years follow-up
Physical activity in relation to development of islet autoantibodies, progression to multiple islet autoantibodies and clinical type 1 diabetes
Investigate the impact of physical activity, measured by summary statistics from an accelerometer worn during 1 week/year on the risk of developing islet autoantibodies and progress to multiple islet autoantibodies and clinical type 1 diabetes. The hypothesis is that increased time and intensity of physical activity decreases the risk of islet autoimmunity and the rate of progression to multiple islet autoantibodies and type 1 diabetes.
Measured: From enrollement to a maximum of 10 years follow up.
Measurements derived from continous glucose monitoring (CGM) compared to blood glucose testing during OGTT in diagnosing early stages of type 1 diabetes
Investigate different methods of an early diagnosis of stage 2 and 3 type 1 diabetes as alternative options for oral glucose tolerance tests. Measurements derived from continuous glucose monitoring (CGM), such as mean glucose, standard deviation, interquartile range, coefficient of variation, Time in Range (TIR), Time Below Range (TBR), Low Blood Glucose Index (LBGI), Mean Amplitude of Glycemic Excursions (MAGE) will be used. The hypothesis is that CGM data can be interpreted and summarized using one or more summary statistics for which specific cut-off values could be defined and validated, which could be used in the clinic replacing the need for performing OGTT.
Measured: From enrollment to a maximum of 10 years follow-up
Psychological impact of screening and follow up, measured by validated questionnaires
Investigate the psychological impact of being aware that the child is at a higher risk of type 1 diabetes, as measured by anxiety levels, study satisfaction, compliance with screening and follow-up, with respect to having first degree relatives with type 1 diabetes, demographic and socioeconomic factors. The hypothesis is that factors associated with anxiety can be identified, and that anxiety and satisfaction can be improved by providing parents with adequate information, especially in parents more prone to developing anxiety
Measured: From enrollment to a maximum of 10 years follow-up
Psychological impact of screening after diagnosis measured by validated questionnaires
Investigate the psychological impact during the first 5 years after a diagnosis of stage 3 type 1 diabetes in children previously followed in the study compared to children not followed before the diagnosis. The hypothesis is that screening and follow-up and an early diagnosis of type 1 diabetes improves coping in the families.
Measured: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
Metabolic control after clinical diagnosis
Investigate the metabolic control (measured by HbA1c (mmol/mol), fasting and stimulated C-peptide and data derived from CGM (mean glucose, SD)) during the first 5 years after a diagnosis of stage 3 type 1 diabetes in children previously followed in the study compared to children not followed before the diagnosis. The hypothesis is that screening and follow-up and an early diagnosis of type 1 diabetes improves metabolic control during at least the first 5 years after diagnosis. For the metabolic control, the national diabetes registry data will be used as a reference group.
Measured: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start14 Oct 2024
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (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 MellitusStudies of the same condition, open and under way.
- More trials run by Lund 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Elding Larsson, MD, PhD, Prof., Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676566
- Sponsor's protocol ID
- iT1D/2024
- Acronym
- iT1D
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Number of particiants and if they have genetic risk, single or multiple autoantibodies (stage 2 type 1 diabetes) and number diagnosed with stage 3 type 1 diabetes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06676566
- Acronym / sponsor ID
- iT1D / iT1D/2024
- Conditions
- Type 1 Diabetes Mellitus, Stage 2 Type 1 Diabetes, Stage 1 Type 1 Diabetes, Stage 3 Type 1 Diabetes
- Keywords
- type 1 diabetes, genetic risk, islet autoantibodies, staging of type 1 diabetes, islet autoimmunity, children, follow-up, autoantibody screening
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 6 Nov 2024 (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 aim is to investigate whether screening for islet autoantibodies, regular follow-up, and increased knowledge in families about the progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an earlier diagnosis of stage 3 type 1 diabetes compared to no screening or follow-up.
Risk factors studied in relation to disease progression are the impact of higher-than-average weight gain, insulin resistance, and physical activity, both individually and in combination, on the risk of developing autoantibodies and disease progression.
An alternative diagnostic method, continuous glucose monitoring (CGM), will be evaluated for its for usefullness in early diagnosis of stage 2 and 3 type 1 diabetes as alternatives to oral glucose tolerance tests.
Another aim is to investigate the psychological impact of being aware that the children are at a higher risk of type 1 diabetes.
When a child in the study develops stage 3 type 1 diabetes, the psychological impact and metabolic control during the first five years after diagnosis will be compared to children not followed before the diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Genetic risk without islet autoantibodies | – | –This group has more than 10% risk of early onset of islet autoimmunity and can come to visits at 2, 6 and 10 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. The child will wear an accelerometer for one week after each visit. |
| Genetic risk with 1 islet autoantibody | – | –This group will be followed annually up to diabetes diagnosis or to 18 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. The child will wear an accelerometer for one week after each visit. |
| Genetic risk with multiple islet autoantibodies | – | –This group will come to visits every three months up to diagnosis or 18 years of age. At the visits blood samples are drawn and disease risk information and information about symptoms is given. An OGTT will be performed at some of the visits. The child will wear an accelerometer and a CGM for one week after each visit. |
| Children with stage 3 type 1 diabetes who have taken part in the study before diagnosis | – | –Annual visits at the study center will continue for the first 5 years after diagnosis. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who have been screened for genetic risk for type 1 diabetes at birth in the ASTR1D study and other children who have been screened for either genetic risk or islet autoantibodies in other studies.
Key inclusion criteria (4 listed)
- Children 0 -10 years with high or moderate genetic risk of type 1 diabetes, measured by a combined analysis of HLA and non-HLA SNPs. Moderate genetic risk is defined as 8-10% risk of developing multiple islet autoantibodies before 6 years of age, and high genetic risk as over 10% risk of developing multiple islet autoantibodies before 6 years of age.
- Children 0-18 years of age screened in other research studies or tested at a clinical site and found to have a single autoantibody (before stage 1 type 1 diabetes) or multiple islet autoantibodies without or with impaired glucose tolerance (stage 1 or 2 type 1 diabetes, respectively).
- Children will be invited to participate in the current study if they have moderate or high genetic risk and 1) have participated in a prevention trial but have dropped out or the trial has ended 2) are not willing to participate in prevention trial.
- Children screened and found to be positive for islet autoantibodies in other studies (TEDDY, TrialNet, Innodia etc) or in clinical settings but which have not progressed to stage 3 type 1 diabetes can also be invited to participate in the current study.
Key exclusion criteria (2 listed)
- Stage 3 type 1 diabetes
- Currently participating in a prevention study
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
Early diabetes diagnosis, measured as HbA1c, symptoms, incidence of DKA
Time frame: From enrollment to a maximum of 10 years follow-up
Investigate if screening for islet autoantibodies, regular follow-up and increased knowledge in the families regarding progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an early diagnosis of stage 3 type 1 diabetes, measured by HbA1c and symptoms, and prevents DKA as compared to no screening or follow-up. The hypothesis is that screening and follow-up ensures an early diagnosis with no/few symptoms and prevents DKA.
Growth in relation to development of 1 islet autoantibody and progression to multiple islet autoantibodies and clinical type 1 diabetes
Time frame: From enrollement to a maximum of 10 years follow up.
Investigate the impact of higher-than-average weight gain (SDS body weight in kg) on the risk of developing islet autoantibodies, progressing from one to several autoantibodies (stage 1 or 2 type 1 diabetes) and to progression to clinical type 1 diabetes (stage 3 type 1 diabetes). The hypothesis is that higher than average weight gain increase the risk of islet autoimmunity.
Insulin resistance in relation to development of islet autoantibodies, progression to multiple islet autoantibodies and clinical type 1 diabetes
Time frame: From enrollment to a maximum of 10 years follow-up
Investigate the impact insulin resistance, measured as HOMA-IR on the risk of developing islet autoantibodies, progression from a single islet autoantibody to multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) and to stage 3 clinical type 1 diabetes. The hypothesis is that higher insulin resistance, measured as HOMA-IR, increase the risk of developing islet autoantibodies and the rate of progression to multiple islet autoantibodies and stage 3 type 1 diabetes.
Physical activity in relation to development of islet autoantibodies, progression to multiple islet autoantibodies and clinical type 1 diabetes
Time frame: From enrollement to a maximum of 10 years follow up.
Investigate the impact of physical activity, measured by summary statistics from an accelerometer worn during 1 week/year on the risk of developing islet autoantibodies and progress to multiple islet autoantibodies and clinical type 1 diabetes. The hypothesis is that increased time and intensity of physical activity decreases the risk of islet autoimmunity and the rate of progression to multiple islet autoantibodies and type 1 diabetes.
Measurements derived from continous glucose monitoring (CGM) compared to blood glucose testing during OGTT in diagnosing early stages of type 1 diabetes
Time frame: From enrollment to a maximum of 10 years follow-up
Investigate different methods of an early diagnosis of stage 2 and 3 type 1 diabetes as alternative options for oral glucose tolerance tests. Measurements derived from continuous glucose monitoring (CGM), such as mean glucose, standard deviation, interquartile range, coefficient of variation, Time in Range (TIR), Time Below Range (TBR), Low Blood Glucose Index (LBGI), Mean Amplitude of Glycemic Excursions (MAGE) will be used. The hypothesis is that CGM data can be interpreted and summarized using one or more summary statistics for which specific cut-off values could be defined and validated, which could be used in the clinic replacing the need for performing OGTT.
Psychological impact of screening and follow up, measured by validated questionnaires
Time frame: From enrollment to a maximum of 10 years follow-up
Investigate the psychological impact of being aware that the child is at a higher risk of type 1 diabetes, as measured by anxiety levels, study satisfaction, compliance with screening and follow-up, with respect to having first degree relatives with type 1 diabetes, demographic and socioeconomic factors. The hypothesis is that factors associated with anxiety can be identified, and that anxiety and satisfaction can be improved by providing parents with adequate information, especially in parents more prone to developing anxiety
Psychological impact of screening after diagnosis measured by validated questionnaires
Time frame: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
Investigate the psychological impact during the first 5 years after a diagnosis of stage 3 type 1 diabetes in children previously followed in the study compared to children not followed before the diagnosis. The hypothesis is that screening and follow-up and an early diagnosis of type 1 diabetes improves coping in the families.
Metabolic control after clinical diagnosis
Time frame: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
Investigate the metabolic control (measured by HbA1c (mmol/mol), fasting and stimulated C-peptide and data derived from CGM (mean glucose, SD)) during the first 5 years after a diagnosis of stage 3 type 1 diabetes in children previously followed in the study compared to children not followed before the diagnosis. The hypothesis is that screening and follow-up and an early diagnosis of type 1 diabetes improves metabolic control during at least the first 5 years after diagnosis. For the metabolic control, the national diabetes registry data will be used as a reference group.
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Number of particiants and if they have genetic risk, single or multiple autoantibodies (stage 2 type 1 diabetes) and number diagnosed with stage 3 type 1 diabetes
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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.
Helena Elding Larsson, MD, PhD, Prof. principal investigator
Lund University
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 and Stage 2 Type 1 Diabetes, run by Lund 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 2026. 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?
Early diabetes diagnosis, measured as HbA1c, symptoms, incidence of DKA (time frame: From enrollment to a maximum of 10 years follow-up). The study lists 8 primary outcomes in all. 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 3 Sep 2026.