An observational study in Type 1 Diabetes Mellitus, Stage 2 Type 1 Diabetes and Stage 1 Type 1 Diabetes, sponsored by Lund University. Enrolling by invitation at 1 site in Sweden. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Lund University · Observational
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 600 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Annual visits at the study center will continue for the first 5 years after diagnosis.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
Plan to share: 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
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Oct 2034, 119 months after the start.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 119 months is above that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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