Type 1 DiabetesIDACNCT06670625
Intensive Dietary and Activity Counselling (IDAC)
A study testing IDAC+ in people with Type 1 Diabetes and Autoimmune Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
The aim of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development… Read more about this study
- Who is it for?
- Ages 3 to 4 months
- Conditions the study is for
- Type 1 Diabetes, Autoimmune Diabetes
- What is being tested?
- IDAC+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,244 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2025to 31 Dec 2031
- Phase
- Interventional
- 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 3 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks).
- An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years.
- Genetic inclusion criteria: Children without a T1D-FDR having HLA DR3/DR4-DQ8, DR4-DQ8/DR4-DQ8 or DR4-DQ8/DR4-DQ7 rs6901541 C/T genotype and:
- for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A.
- for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A.
- Children with a T1D-FDR, all DR3/3, DR4-DQ8/DR4-DQ7 and DR4-DQ8/x where x is none of the following protective alleles: DRB11501, DQB10503, DRB11303 will be included regardless of genetic risk score.
- Written informed consent signed by the custodial parent(s).
Who cannot join
- Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators.
- Preterm delivery < 36 weeks of gestation.
- Any condition that could be associated with poor compliance.
- Diagnosis of diabetes prior to recruitment or randomization.
- Current use of any investigational drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Clinical Research Center (CRC), Bldng 60:11
Malmö, 20502
Carin Andrén Aronsson, PhD, +46 40391113, carin.andren_aronsson@med.lu.se
About this study
Official title: Intensive Dietary and Activity Counselling
The aim of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development of islet autoimmunity (beta-cell autoantibodies).
The main hypotheses are:
Read more
- Early lifestyle influences the susceptibility to islet autoimmunity (IA) by increasing beta-cell vulnerability. Introducing a "healthy beta-cell lifestyle" from infancy will reduce beta-cell vulnerability and the likelihood of IA.
- Will promotion of a healthy beta-cell environment during early childhood in children with increased genetic risk of T1D reduce beta-cell stress, increased weight gain and development of islet autoantibodies?
The primary objective is to determine whether an Intensive Diet and Activity Counseling (IDAC) from age 3 months to age 2 years improves beta-cell health in children with increased risk for islet autoimmunity.
Secondary objectives are to determine whether IDAC is associated with infant and early childhood growth and body composition and to determine whether IDAC reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood.
Participants will be randomized (ratio 1:1) to control group and intervention group. Breastfeeding status at time of randomization will be taken into account.
Participants will be enrolled by the age of four months and visit the research clinic ever third months up until the age of 24 months, and then yearly up until the age of 6 years.
- Anthropometric measurements and blood draw will be taken at each visit.
- Questionnaires focusing on breastfeeding and early infant feeding habits will be used at each visit.
- 24hrs recalls will be done at the age of 6, 9, 12, 18 and 24 months of age.
- Physical activity will be estimated using questionnaires (3, 6, 9 months) and accelerometer data (12, 18 and 24 months).
- Stool samples will be collected at 6, 12 and 18 months of age
Read the detailed description
The aim is to test previously described associations between increased growth, diet and physical activity and the development of type 1 diabetes-related autoantibodies. In a randomized trial, it is investigated whether intensive counseling regarding diet and physical activity already during infancy affects metabolism (beta-cell health), growth and the risk of type 1 diabetes-related autoantibodies.
Rapid growth and/or weight gain during childhood has been shown in previous studies to be associated with an increased risk of developing type 1 diabetes-related autoantibodies (IA, IA-2A, GADA, ZnT8RA, ZnT8WA), a precursor to autoimmune type 1 diabetes. Rapid growth can, in theory, stress the beta cells through an increased need for insulin and make them more susceptible to an autoimmune attack. Adipocytokines and inflammatory cytokines secreted from adipose tissue and overload induced by circulating nutrients have been discussed to play a role in the pathogenesis of autoimmune diseases through their impact on immune cell function and activation.
Although previous research has used different measures of weight gain and obesity (BMI, body fat%, growth rate), the results are relatively consistent and show a link between overweight and obesity in early years and an increased risk of beta cell autoimmunity and progression to type 1 diabetes. Specific growth patterns during early childhood have also been associated with type 1 diabetes-related autoantibodies and progression to T1D in children at genetic risk.
Dietary protein intake has been considered a key player in regulating body weight in infants based on results from both intervention and observational studies. A high protein intake, especially from animal sources, has been suggested to affect the development and function of the immune system, potentially contributing to the development of autoimmune diseases such as type 1 diabetes. In addition, previous studies have shown a link between cow's milk consumption (both age at first introduction and quantity) with the risk of T1D. However, exactly how this happens is not entirely clear, and more research is needed to better understand the connections. Previous studies have shown that children who had a high protein intake during the first year of life had a slightly higher risk of developing T1D-related autoantibodies. There is some evidence to suggest that both the energy and protein content of the diet may influence the risk of developing T1D, particularly through mechanisms related to growth, weight gain, and immune response. However, the evidence is not entirely consistent and more research is needed to clarify these relationships and mechanisms. According to the 'early protein hypothesis', a high intake of protein during early childhood stimulates growth, especially adipose tissue, and later leads to an increased risk of obesity. The hypothesis is that a high-protein diet in early childhood may increase levels of insulin-releasing amino acids (branched-chain amino acids), which in turn may stimulate insulin- and insulin-like growth factor 1 (IGF-1) secretion.
In this study, the investigators will test previously described associations by including infants with an increased genetic risk of T1D in a randomized trial, where the parents receive either the usual advice given by the child health center or an intensive counseling regarding diet and physical activity. All children are monitored for growth, metabolic parameters and development of type 1 diabetes-related autoantibodies.
During the intervention period (3 months - 2 years of age), the study will focus on the following:
- Support continued breastfeeding up to 12 months of age.
- Advise families on diet and physical activity during infancy in accordance with national/international recommendations.
- Study growth patterns in infants/children through anthropometric measurements (weight, height) and body composition (skin fold measurement).
The primary endpoint is beta-cell health at 36 months of age, assessed as the proinsulin/C-peptide ratio at glucose load (OGTT).
Secondary endpoints are:
- accelerated growth during infancy
- overweight at 36 months of age
- time to development of persistent confirmed islet autoantibodies or type 1 diabetes
Visits to the research clinic take place every three months up to the age of 2, then once a year up to the age of 6.
Study duration per research participant; minimum 4 months of age to 3 years of age, maximum of 3 months of age to 6 years of age.
- Conditions
- Type 1 Diabetes, Autoimmune Diabetes
- Being tested
- IDAC+
- Keywords
- islet autoimmunity, children
- 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.
IDAC+Behavioural
Diet and physical activity counselling at baseline, 6, 12 and 24 months visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IDAC+) | Experimental | Participants randomized to the IDAC+ will regularly receive dietary and physical activity advice with focus on continuing breastfeeding up until the age of 12 months, limit the protein intake in the child´s diet (maximum 15E%), limit milk \& milk products (max 150 ml/day), support daily vitamin D supplementation. Specific age-appropriate advice on physical activity will be given to participants. Receives: Behavioral: IDAC+ |
| Control Group | No intervention | No specific advice will be given to this group other than national guidelines similar to those given by the childcare centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell health
Assessed by the proinsulin/ C-peptide ratio during OGTT
Measured: at 36 months
Beta-cell health
Assessed by the Disposition Index relative to insulin resistance (HOMA-IR) IGI30/HOMA-IR (IGI30=Delta insulin 0-30/Delta Glucose 0-30 during OGTT).
Measured: at 36 months
Secondary outcomes (3)
Accelerated growth during infancy
Assessed using anthropometric measurements: weight (kg) and height (cm) is used to calculate change in growth rate.
Measured: from birth until the age of 36 months
Overweight at the age of 36 months
Assessed using anthropometric measurements (BMI in kg/m^2, body fat%)
Measured: measurements collected at 36 months
Development of persistent confirmed islet autoantibodies
Age at persistent confirmed islet autoantibodies (single or multiple)
Measured: from birth until the age of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start15 Mar 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helena Elding Larsson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670625
- Sponsor's protocol ID
- 2024-05217-01
- Acronym
- IDAC
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nitecki M, Gerstein HC, Balmakov Y, Tsur E, Babushkin V, Michaeli T, Afek A, Pinhas-Hamiel O, Cukierman-Yaffe T, Twig G. High BMI and the risk for incident type 1 Diabetes Mellitus: a systematic review and meta-analysis of aggregated cohort studies. Cardiovasc Diabetol. 2023 Nov 2;22(1):300. doi: 10.1186/s12933-023-02007-y.
PubMed 37919779Arnesen EK, Thorisdottir B, Lamberg-Allardt C, Barebring L, Nwaru B, Dierkes J, Ramel A, Akesson A. Protein intake in children and growth and risk of overweight or obesity: A systematic review and meta-analysis. Food Nutr Res. 2022 Feb 21;66. doi: 10.29219/fnr.v66.8242. eCollection 2022.
PubMed 35261578Liu X, Vehik K, Huang Y, Elding Larsson H, Toppari J, Ziegler AG, She JX, Rewers M, Hagopian WA, Akolkar B, Krischer JP; TEDDY Study Group. Distinct Growth Phases in Early Life Associated With the Risk of Type 1 Diabetes: The TEDDY Study. Diabetes Care. 2020 Mar;43(3):556-562. doi: 10.2337/dc19-1670. Epub 2020 Jan 2.
PubMed 31896601Elding Larsson H, Vehik K, Haller MJ, Liu X, Akolkar B, Hagopian W, Krischer J, Lernmark A, She JX, Simell O, Toppari J, Ziegler AG, Rewers M; TEDDY Study Group. Growth and Risk for Islet Autoimmunity and Progression to Type 1 Diabetes in Early Childhood: The Environmental Determinants of Diabetes in the Young Study. Diabetes. 2016 Jul;65(7):1988-95. doi: 10.2337/db15-1180. Epub 2016 Mar 18.
PubMed 26993064Aronsson CA, Tamura R, Vehik K, Uusitalo U, Yang J, Haller MJ, Toppari J, Hagopian W, McIndoe RA, Rewers MJ, Ziegler AG, Akolkar B, Krischer JP, Norris JM, Virtanen SM, Larsson HE. Dietary Intake and Body Mass Index Influence the Risk of Islet Autoimmunity in Genetically At-Risk Children: A Mediation Analysis Using the TEDDY Cohort. Pediatr Diabetes. 2023;2023:3945064. doi: 10.1155/2023/3945064. Epub 2023 Feb 17.
PubMed 37614409Aronsson CA, Hummel S, Eriksson Hallstrom E, Gudmundsson T, Maziarz M, Elding Larsson H. Intensive Dietary and Activity Counselling (IDAC) study: a randomised trial following infants genetically susceptible to type 1 diabetes to prevent beta-cell dysfunction and islet autoimmunity - a study protocol. BMJ Open. 2026 May 14;16(5):e112056. doi: 10.1136/bmjopen-2025-112056.
PubMed 42134839
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Dietary and Activity Counselling
- ClinicalTrials.gov ID
- NCT06670625
- Acronym / sponsor ID
- IDAC / 2024-05217-01
- Conditions
- Type 1 Diabetes, Autoimmune Diabetes
- Keywords
- islet autoimmunity, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,244 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 1 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 of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development of islet autoimmunity (beta-cell autoantibodies).
The main hypotheses are:
- Early lifestyle influences the susceptibility to islet autoimmunity (IA) by increasing beta-cell vulnerability. Introducing a "healthy beta-cell lifestyle" from infancy will reduce beta-cell vulnerability and the likelihood of IA.
- Will promotion of a healthy beta-cell environment during early childhood in children with increased genetic risk of T1D reduce beta-cell stress, increased weight gain and development of islet autoantibodies?
The primary objective is to determine whether an Intensive Diet and Activity Counseling (IDAC) from age 3 months to age 2 years improves beta-cell health in children with increased risk for islet autoimmunity.
Secondary objectives are to determine whether IDAC is associated with infant and early childhood growth and body composition and to determine whether IDAC reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood.
Participants will be randomized (ratio 1:1) to control group and intervention group. Breastfeeding status at time of randomization will be taken into account.
Participants will be enrolled by the age of four months and visit the research clinic ever third months up until the age of 24 months, and then yearly up until the age of 6 years.
- Anthropometric measurements and blood draw will be taken at each visit.
- Questionnaires focusing on breastfeeding and early infant feeding habits will be used at each visit.
- 24hrs recalls will be done at the age of 6, 9, 12, 18 and 24 months of age.
- Physical activity will be estimated using questionnaires (3, 6, 9 months) and accelerometer data (12, 18 and 24 months).
- Stool samples will be collected at 6, 12 and 18 months of age
Detailed description
The aim is to test previously described associations between increased growth, diet and physical activity and the development of type 1 diabetes-related autoantibodies. In a randomized trial, it is investigated whether intensive counseling regarding diet and physical activity already during infancy affects metabolism (beta-cell health), growth and the risk of type 1 diabetes-related autoantibodies.
Rapid growth and/or weight gain during childhood has been shown in previous studies to be associated with an increased risk of developing type 1 diabetes-related autoantibodies (IA, IA-2A, GADA, ZnT8RA, ZnT8WA), a precursor to autoimmune type 1 diabetes. Rapid growth can, in theory, stress the beta cells through an increased need for insulin and make them more susceptible to an autoimmune attack. Adipocytokines and inflammatory cytokines secreted from adipose tissue and overload induced by circulating nutrients have been discussed to play a role in the pathogenesis of autoimmune diseases through their impact on immune cell function and activation.
Although previous research has used different measures of weight gain and obesity (BMI, body fat%, growth rate), the results are relatively consistent and show a link between overweight and obesity in early years and an increased risk of beta cell autoimmunity and progression to type 1 diabetes. Specific growth patterns during early childhood have also been associated with type 1 diabetes-related autoantibodies and progression to T1D in children at genetic risk.
Dietary protein intake has been considered a key player in regulating body weight in infants based on results from both intervention and observational studies. A high protein intake, especially from animal sources, has been suggested to affect the development and function of the immune system, potentially contributing to the development of autoimmune diseases such as type 1 diabetes. In addition, previous studies have shown a link between cow's milk consumption (both age at first introduction and quantity) with the risk of T1D. However, exactly how this happens is not entirely clear, and more research is needed to better understand the connections. Previous studies have shown that children who had a high protein intake during the first year of life had a slightly higher risk of developing T1D-related autoantibodies. There is some evidence to suggest that both the energy and protein content of the diet may influence the risk of developing T1D, particularly through mechanisms related to growth, weight gain, and immune response. However, the evidence is not entirely consistent and more research is needed to clarify these relationships and mechanisms. According to the 'early protein hypothesis', a high intake of protein during early childhood stimulates growth, especially adipose tissue, and later leads to an increased risk of obesity. The hypothesis is that a high-protein diet in early childhood may increase levels of insulin-releasing amino acids (branched-chain amino acids), which in turn may stimulate insulin- and insulin-like growth factor 1 (IGF-1) secretion.
In this study, the investigators will test previously described associations by including infants with an increased genetic risk of T1D in a randomized trial, where the parents receive either the usual advice given by the child health center or an intensive counseling regarding diet and physical activity. All children are monitored for growth, metabolic parameters and development of type 1 diabetes-related autoantibodies.
During the intervention period (3 months - 2 years of age), the study will focus on the following:
- Support continued breastfeeding up to 12 months of age.
- Advise families on diet and physical activity during infancy in accordance with national/international recommendations.
- Study growth patterns in infants/children through anthropometric measurements (weight, height) and body composition (skin fold measurement).
The primary endpoint is beta-cell health at 36 months of age, assessed as the proinsulin/C-peptide ratio at glucose load (OGTT).
Secondary endpoints are:
- accelerated growth during infancy
- overweight at 36 months of age
- time to development of persistent confirmed islet autoantibodies or type 1 diabetes
Visits to the research clinic take place every three months up to the age of 2, then once a year up to the age of 6.
Study duration per research participant; minimum 4 months of age to 3 years of age, maximum of 3 months of age to 6 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IDAC+) | Experimental | Behavioral: IDAC+Participants randomized to the IDAC+ will regularly receive dietary and physical activity advice with focus on continuing breastfeeding up until the age of 12 months, limit the protein intake in the child´s diet (maximum 15E%), limit milk \& milk products (max 150 ml/day), support daily vitamin D supplementation. Specific age-appropriate advice on physical activity will be given to participants. |
| Control Group | No intervention | –No specific advice will be given to this group other than national guidelines similar to those given by the childcare centers. |
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks).
- An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years.
- Genetic inclusion criteria: Children without a T1D-FDR having HLA DR3/DR4-DQ8, DR4-DQ8/DR4-DQ8 or DR4-DQ8/DR4-DQ7 rs6901541 C/T genotype and:
- for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A.
- for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A.
Key exclusion criteria (5 listed)
- Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators.
- Preterm delivery < 36 weeks of gestation.
- Any condition that could be associated with poor compliance.
- Diagnosis of diabetes prior to recruitment or randomization.
- Current use of any investigational drug.
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 |
|---|---|---|
| IDAC+Diet and physical activity counselling at baseline, 6, 12 and 24 months visit. | Behavioural | Intervention Group (IDAC+) |
Primary outcome
Beta-cell health
Time frame: at 36 months
Assessed by the proinsulin/ C-peptide ratio during OGTT
Beta-cell health
Time frame: at 36 months
Assessed by the Disposition Index relative to insulin resistance (HOMA-IR) IGI30/HOMA-IR (IGI30=Delta insulin 0-30/Delta Glucose 0-30 during OGTT).
3 secondary outcomes
Accelerated growth during infancy
Time frame: from birth until the age of 36 months
Overweight at the age of 36 months
Time frame: measurements collected at 36 months
Development of persistent confirmed islet autoantibodies
Time frame: from birth until the age of 36 months
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 13 Apr 2026.
- Background: PubMed 37919779Nitecki M, Gerstein HC, Balmakov Y, Tsur E, Babushkin V, Michaeli T, Afek A, Pinhas-Hamiel O, Cukierman-Yaffe T, Twig G. High BMI and the risk for incident type 1 Diabetes Mellitus: a systematic review and meta-analysis of aggregated cohort studies. Cardiovasc Diabetol. 2023 Nov 2;22(1):300. doi: 10.1186/s12933-023-02007-y.
- Background: PubMed 35261578Arnesen EK, Thorisdottir B, Lamberg-Allardt C, Barebring L, Nwaru B, Dierkes J, Ramel A, Akesson A. Protein intake in children and growth and risk of overweight or obesity: A systematic review and meta-analysis. Food Nutr Res. 2022 Feb 21;66. doi: 10.29219/fnr.v66.8242. eCollection 2022.
- Background: PubMed 31896601Liu X, Vehik K, Huang Y, Elding Larsson H, Toppari J, Ziegler AG, She JX, Rewers M, Hagopian WA, Akolkar B, Krischer JP; TEDDY Study Group. Distinct Growth Phases in Early Life Associated With the Risk of Type 1 Diabetes: The TEDDY Study. Diabetes Care. 2020 Mar;43(3):556-562. doi: 10.2337/dc19-1670. Epub 2020 Jan 2.
- Background: PubMed 26993064Elding Larsson H, Vehik K, Haller MJ, Liu X, Akolkar B, Hagopian W, Krischer J, Lernmark A, She JX, Simell O, Toppari J, Ziegler AG, Rewers M; TEDDY Study Group. Growth and Risk for Islet Autoimmunity and Progression to Type 1 Diabetes in Early Childhood: The Environmental Determinants of Diabetes in the Young Study. Diabetes. 2016 Jul;65(7):1988-95. doi: 10.2337/db15-1180. Epub 2016 Mar 18.
- Background: PubMed 37614409Aronsson CA, Tamura R, Vehik K, Uusitalo U, Yang J, Haller MJ, Toppari J, Hagopian W, McIndoe RA, Rewers MJ, Ziegler AG, Akolkar B, Krischer JP, Norris JM, Virtanen SM, Larsson HE. Dietary Intake and Body Mass Index Influence the Risk of Islet Autoimmunity in Genetically At-Risk Children: A Mediation Analysis Using the TEDDY Cohort. Pediatr Diabetes. 2023;2023:3945064. doi: 10.1155/2023/3945064. Epub 2023 Feb 17.
- Derived from this study: PubMed 42134839Aronsson CA, Hummel S, Eriksson Hallstrom E, Gudmundsson T, Maziarz M, Elding Larsson H. Intensive Dietary and Activity Counselling (IDAC) study: a randomised trial following infants genetically susceptible to type 1 diabetes to prevent beta-cell dysfunction and islet autoimmunity - a study protocol. BMJ Open. 2026 May 14;16(5):e112056. doi: 10.1136/bmjopen-2025-112056.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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, PhD 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?
A study testing IDAC+ in people with Type 1 Diabetes and Autoimmune 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 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?
Contact Carin Andrén Aronsson, PhD (+464039113, carin.andren_aronsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-cell health (time frame: at 36 months). 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 NCT06670625, which also lists 6 linked publications.
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 13 Apr 2026.