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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: Blood draw for insulin auto-anti body tests*

Study type: Interventional

Funder types: Industry

Identifiers

NCT03312478

U1111-1200-1995 (Other Identifier)

LANTUL08473

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 375 patients

Sex: All

Ages: 2 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 2 patient groups

Case

Other group

Description:

Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases

Treatment:

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

Control

Other group

Description:

Age-matched non-diabetic controls as described in the inclusion criteria for controls

Treatment:

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