NCT03312478

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Blood draw for insulin auto-anti body tests*	Pharmaceutical form: N/A Route of administration: N/A

Timeline

• Start date: 2017-10-13
• Primary completion: 2018-08-19
• Completion: 2018-08-19
• First posted: 2017-10-17
• Last updated: 2022-04-25

Locations

1 site across 1 country: Pakistan