Intranasal Insulin for Prevention of Type 1 Diabetes

Study Overview
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Brief Summary
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Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth for HLA alleles that carry increased risk to or protection from development of type 1 diabetes. Children carrying increased risk are followed at 3-12-month intervals for development of diabetes-associated autoantibodies. Children having at least two types of autoantibodies (of the four measured) in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial. Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes. The primary outcome measure is development of clinical diabetes.

Detailed Description
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Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth for the HLA-DQB1 and DQA1 alleles that carry increased risk to or protection from development of type 1 diabetes. Children carrying increased risk are followed at 3-month intervals until 2 years of age and then at 6-12-month intervals until,15 years of age for development of diabetes-associated autoantibodies (autoantibodies against islet cells, insulin, glutamic acid decarboxylase and IA-2 protein). Children having at least two types of autoantibodies of the four measured in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial. Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes. The primary outcome measure is development of clinical diabetes, but serum concentrations of autoantibodies, responses to intravenous glucose tolerance test and possible side effects of therapy are also closely monitored.

Official Title
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Intranasal Insulin for Prevention of Type 1 Diabetes in Children Carrying Increased HLA-Conferred Genetic Risk

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: daily intranasal administration of insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children carrying HLA-conferred genetic risk for developing type 1 diabetes have had at least two types of autoantibodies of ICA, IAA, GADA and IA-2A in at least two consecutive blood samples drawn at least 3 months apart age at least one year Exclusion Criteria: severe other disease age above 15 years

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: daily intranasal administration of insulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of clinical type 1 diabetes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and concentration in serum of diabetes-associated autoantibodies (ICA, IAA, GADA and IA-2A) |  |  | 
| Responses to intravenous glucose tolerance test |  |  | 
| Possible side effects of therapy including hypoglycemia |  |  | 
| Changes in serum metabolite patterns (metabolomics) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, juvenile diabetes, insulin deficiency