Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes

Study Overview
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Brief Summary
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Primary Objective: To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics. Secondary Objectives: To document the profile of Type 1 diabetes patients. To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated hemoglobin [HbA1c]) of Type 1 diabetes. To capture the current therapeutic management.

Detailed Description
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The overall duration of this study is expected to be 12 months. The recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the patients shall be conducted after 15 days ± 5 days. *Each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through centralized laboratories for all recruited patients. Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.

Official Title
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To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Blood draw for insulin auto-anti body tests*


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Inclusion Criteria for Cases Age ≥ 2 years and ≤ 20 years. Type 1 diabetes mellitus (T1DM) at any stage of life assessed as: Insulin initiated within one year of diagnosis. One or more islet autoantibodies (insulin auto-antibodies [IAA], glutamic acid decarboxylase (GAD), or IA2) positive at the time of enrolment. The laboratory value for IAA ≥ 2.4 units/mL, ≥ 10 IU/mL for IA2 and ≥ 5 IU/mL for anti-GAD to be labelled as positive. Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than legal limit which is 18 years of age. Inclusion Criteria for Controls Age ≥ 2 years and ≤ 20 years. Every control will be matched for a specific patient within ± two years of age. Non diabetic. All islet autoantibodies negative at the time of enrolment (IAA, GAD, or IA2). The laboratory value for IAA ≤ 2.4 units/mL, ≤ 10 IU/mL for IA2, and ≤ 5 IU/mL for anti-GAD to be labelled as negative. Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than 18 years of age. Exclusion criteria: Exclusion Criteria for Cases: Age ≤ 2 years and >20 years. Patients with any other pre-existing auto-immune disease. Gestational Diabetes. Pregnant Woman. Exclusion Criteria for Controls: Age ≤ 2 years and > 20 years. Patient with history of Type 1 (T1) and Type 2 Diabetes Mellitus (T2DM). History of T1 and T2DM in siblings. Gestational Diabetes. Pregnant Woman. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Case<br>Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases | Drug: Blood draw for insulin auto-anti body tests*<br>* Pharmaceutical form: N/A Route of administration: N/A<br>|
| Other: Control<br>Age-matched non-diabetic controls as described in the inclusion criteria for controls | Drug: Blood draw for insulin auto-anti body tests*<br>* Pharmaceutical form: N/A Route of administration: N/A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Odds of Type 1 Diabetes Mellitus child having a diabetic parent | Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of this population by gender | Categorical variables (gender) will be presented as proportions | 12 months | 
| Characterization of this population by age | Categorical variables (age) will be presented as proportions | 12 months | 
| Characterization of this population by socio-economic profile | Categorical variables (socio-economic profile) will be presented as proportions | 12 months | 
| Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients | Mean HbA1c | 12 months | 
| Standard deviation of HbA1c in T1DM patients | Standard deviation of HbA1c | 12 months | 
| Distribution of prescribed therapies by type of insulin to T1DM patients | Distribution of prescribed therapies by type of insulin will be presented as proportions | 12 months | 
| Means of fasting blood glucose (FBG) in T1DM patients | Mean Fasting Blood Glucose | 12 months | 
| Standard deviation of FBG in T1DM patients | Standard deviation of FBG | 12 months | 
| Duration of diabetes in parent | Mean duration of diabetes in parent | 12 months | 
| Mean duration of diabetes in parent | Standard deviation of duration of diabetes in parent | 12 months | 
| Characterization of family history of diabetes | Categorical variables will be measured as proportions | 12 months | 
| Characterization of frequency of consultation | Number of consultations per month | 12 months | 
| Characterization of diabetes education | Number of sessions per month | 12 months |