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

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%.

Study Overview

• Status: Completed
• Conditions: Diabetic Children
• Intervention / Treatment: Diagnostic test: skin prick test

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • None Selected
    • Mansoura, None Selected, Egypt, 35516
      • Mansoura University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with at least 2 years' duration of Type 1 Diabetes Mellitus. Participants: among 200 cases with Type 1 DM children following up at endocrinology unit

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
allergic type 1 DM children; 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; 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.
Non-allergic type 1 DM children; Forty-five Non-allergic type 1 DM children were selected as age and sex matched control group.	Diagnostic test: skin prick test; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University Children Hospital
• Investigators: Study Director: Engy Osman, MD, assistant Professor, Pediatrics Department, Faculty of Medicine, Mansoura University, Egypt.

Publications and helpful links

General Publications

• Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, Durham S, Fokkens W, Gjomarkaj M, Haahtela T, Bom AT, Wohrl S, Maibach H, Lockey R. The skin prick test - European standards. Clin Transl Allergy. 2013 Feb 1;3(1):3. doi: 10.1186/2045-7022-3-3.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): December 25, 2019

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 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
• Other Study ID Numbers: MS/17.07.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No