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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
375
Pharmaceutical form: N/A Route of administration: N/A
National Institute of Child Health
Karachi, Sindh, Pakistan
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
Time frame: 12 months
Characterization of this population by gender
Categorical variables (gender) will be presented as proportions
Time frame: 12 months
Characterization of this population by age
Categorical variables (age) will be presented as proportions
Time frame: 12 months
Characterization of this population by socio-economic profile
Categorical variables (socio-economic profile) will be presented as proportions
Time frame: 12 months
Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients
Mean HbA1c
Time frame: 12 months
Standard deviation of HbA1c in T1DM patients
Standard deviation of HbA1c
Time frame: 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
Time frame: 12 months
Means of fasting blood glucose (FBG) in T1DM patients
Mean Fasting Blood Glucose
Time frame: 12 months
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Standard deviation of FBG in T1DM patients
Standard deviation of FBG
Time frame: 12 months
Duration of diabetes in parent
Mean duration of diabetes in parent
Time frame: 12 months
Mean duration of diabetes in parent
Standard deviation of duration of diabetes in parent
Time frame: 12 months
Characterization of family history of diabetes
Categorical variables will be measured as proportions
Time frame: 12 months
Characterization of frequency of consultation
Number of consultations per month
Time frame: 12 months
Characterization of diabetes education
Number of sessions per month
Time frame: 12 months