Clinical trial NCT06676566: Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
Official title: Information, Follow-up and Early Diagnosis of Children at Risk for Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Stage 3 type 1 diabetes
* Currently participating in a prevention study

Primary outcomes:
measure: Early diabetes diagnosis, measured as HbA1c, symptoms, incidence of DKA
timeFrame: From enrollment to a maximum of 10 years follow-up
measure: Growth in relation to development of 1 islet autoantibody and progression to multiple islet autoantibodies and clinical type 1 diabetes
timeFrame: From enrollement to a maximum of 10 years follow up.
measure: Insulin resistance in relation to development of islet autoantibodies, progression to multiple islet autoantibodies and clinical type 1 diabetes
timeFrame: From enrollment to a maximum of 10 years follow-up
measure: Physical activity in relation to development of islet autoantibodies, progression to multiple islet autoantibodies and clinical type 1 diabetes
timeFrame: From enrollement to a maximum of 10 years follow up.
measure: Measurements derived from continous glucose monitoring (CGM) compared to blood glucose testing during OGTT in diagnosing early stages of type 1 diabetes
timeFrame: From enrollment to a maximum of 10 years follow-up
measure: Psychological impact of screening and follow up, measured by validated questionnaires
timeFrame: From enrollment to a maximum of 10 years follow-up
measure: Psychological impact of screening after diagnosis measured by validated questionnaires
timeFrame: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
measure: Metabolic control after clinical diagnosis
timeFrame: From T1D diagnosis until the last visit, maximum 5 years after diagnosis.
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: CRC Jan Waldenströms gata 35
Study officials:
affiliation: Lund University
name: Helena Elding Larsson, MD, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: