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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Blood draw for insulin auto-anti body tests*

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 Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 75510
      • National Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Actual): August 19, 2018
• Study Completion (Actual): August 19, 2018

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: LANTUL08473; U1111-1200-1995 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No