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The Use of CGMS to Detect Alterations of Blood Glucose in Thalassemic Patients

NCT03591900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-07-19

No results posted yet for this study

Summary

The aim of the study is to:

* Assess the pattern of glucose homeostasis in patients with B thalassemia .
* To detect early impairment in glucose metabolism and prediabetic state in B thalassemia patients using continuous glucose monitoring system.
* To study the prevalence and type of DM in B thalassemia patients.
* A comparative study of standard insulin therapy compared to insulin pump therapy in thalassemic diabetic patients will be done.

The study will include screening of 200 children and adolescents who are regularly attending the Hematology Oncology Clinic and fulfilling the inclusion criteria for abnormalities of glucose homeostasis.

A pilot study will be done on 15 patients with abnormal glucose tolerance which will include:

A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration .

B-Therapeutic intervention:

Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to

• Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy.

Conditions

Interventions

DEVICE

insulin pump/CGMS

A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et al., 2009). B-Therapeutic intervention: Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to • Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy(Bruttomesso D et al., 2009).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-06-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591900 on ClinicalTrials.gov