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

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Blood draw for insulin auto-anti body tests*

• Registration Number: NCT03312478
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-12
• Study Start: 2017-10-13
• Study First Posted: 2017-10-17
• Primary Completion: 2018-08-19
• Study Completion: 2018-08-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Blood draw for insulin auto-anti body tests*	Age-matched non-diabetic controls as described in the inclusion criteria for controls
Case	Blood draw for insulin auto-anti body tests*	Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases

Primary Outcome Measures

Name	Time	Method
Odds of Type 1 Diabetes Mellitus child having a diabetic parent	12 months	Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Institute of Child Health; 🇵🇰 Karachi, Sind, Pakistan