Back to resultsAssociation of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes (SHINE)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Blood draw for insulin auto-anti body tests*
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility 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.
Sites / Locations
- National Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Case
Control
Arm Description
Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases
Age-matched non-diabetic controls as described in the inclusion criteria for controls
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Characterization of this population by gender
Categorical variables (gender) will be presented as proportions
Characterization of this population by age
Categorical variables (age) will be presented as proportions
Characterization of this population by socio-economic profile
Categorical variables (socio-economic profile) will be presented as proportions
Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients
Mean HbA1c
Standard deviation of HbA1c in T1DM patients
Standard deviation of HbA1c
Distribution of prescribed therapies by type of insulin to T1DM patients
Distribution of prescribed therapies by type of insulin will be presented as proportions
Means of fasting blood glucose (FBG) in T1DM patients
Mean Fasting Blood Glucose
Standard deviation of FBG in T1DM patients
Standard deviation of FBG
Duration of diabetes in parent
Mean duration of diabetes in parent
Mean duration of diabetes in parent
Standard deviation of duration of diabetes in parent
Characterization of family history of diabetes
Categorical variables will be measured as proportions
Characterization of frequency of consultation
Number of consultations per month
Characterization of diabetes education
Number of sessions per month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03312478
Brief Title
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
Acronym
SHINE
Official Title
To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
August 19, 2018 (Actual)
Study Completion Date
August 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
375 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case
Arm Type
Other
Arm Description
Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases
Arm Title
Control
Arm Type
Other
Arm Description
Age-matched non-diabetic controls as described in the inclusion criteria for controls
Intervention Type
Drug
Intervention Name(s)
Blood draw for insulin auto-anti body tests*
Intervention Description
Pharmaceutical form: N/A
Route of administration: N/A
Primary Outcome Measure Information:
Title
Odds of Type 1 Diabetes Mellitus child having a diabetic parent
Description
Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Characterization of this population by gender
Description
Categorical variables (gender) will be presented as proportions
Time Frame
12 months
Title
Characterization of this population by age
Description
Categorical variables (age) will be presented as proportions
Time Frame
12 months
Title
Characterization of this population by socio-economic profile
Description
Categorical variables (socio-economic profile) will be presented as proportions
Time Frame
12 months
Title
Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients
Description
Mean HbA1c
Time Frame
12 months
Title
Standard deviation of HbA1c in T1DM patients
Description
Standard deviation of HbA1c
Time Frame
12 months
Title
Distribution of prescribed therapies by type of insulin to T1DM patients
Description
Distribution of prescribed therapies by type of insulin will be presented as proportions
Time Frame
12 months
Title
Means of fasting blood glucose (FBG) in T1DM patients
Description
Mean Fasting Blood Glucose
Time Frame
12 months
Title
Standard deviation of FBG in T1DM patients
Description
Standard deviation of FBG
Time Frame
12 months
Title
Duration of diabetes in parent
Description
Mean duration of diabetes in parent
Time Frame
12 months
Title
Mean duration of diabetes in parent
Description
Standard deviation of duration of diabetes in parent
Time Frame
12 months
Title
Characterization of family history of diabetes
Description
Categorical variables will be measured as proportions
Time Frame
12 months
Title
Characterization of frequency of consultation
Description
Number of consultations per month
Time Frame
12 months
Title
Characterization of diabetes education
Description
Number of sessions per month
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Child Health
City
Karachi
State/Province
Sind
ZIP/Postal Code
75510
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
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