IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study

Study Overview
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Brief Summary
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an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.

Official Title
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IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study

Conditions
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Diabetic Children

Intervention / Treatment
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* Diagnostic Test: skin prick test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include: Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL). Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours. Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT). HbA1c ≥6.5%. Exclusion Criteria: presence of other chronic disease associated with DM.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| allergic type 1 DM children<br>45 cases were considered allergic based on written questionnaire taken by the resident. Diagnosis of atopy was confirmed by skin prick testing | Diagnostic Test: skin prick test<br>* Skin prick testing was performed to all diabetic child with history of allergy. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 - 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens. The location of each allergen was marked with a pen on the volar aspect of forearm to properly identify test results, at least 2 cm from the wrist and the antecubital fossae. The distance between two skin prick tests should be appropriate to avoid false-positive reactions due to direct contamination of a nearby test. A drop of each test solution should be placed on the skin in identical order for each subject tested and immediately pricked with a single-head metal lancet.<br>|
| Non-allergic type 1 DM children<br>Forty-five Non-allergic type 1 DM children were selected as age and sex matched control group. | Diagnostic Test: skin prick test<br>* Skin prick testing was performed to all diabetic child with history of allergy. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 - 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens. The location of each allergen was marked with a pen on the volar aspect of forearm to properly identify test results, at least 2 cm from the wrist and the antecubital fossae. The distance between two skin prick tests should be appropriate to avoid false-positive reactions due to direct contamination of a nearby test. A drop of each test solution should be placed on the skin in identical order for each subject tested and immediately pricked with a single-head metal lancet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive skin prick test | a wheal ≥3 mm diameter more than negative control for detection of specific IgE to one or more of common aeroallergens. | 20 minutes |