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

NCT03591900 | Completed DMC

• 1 other identifier: Pediatric hospital ASU
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Diabetes; Prediabetes; B-Thalassemia

Keywords

early diabetes; prediabetes; continuous glucose monitoring system; detection

Outcome Measures

Primary Outcomes (1)

• number of thalassemic patients with impaired glucose tolerance

  to find out the number of patients with thalassemia major having impaired glucose tolerance

  2 years

Secondary Outcomes (2)

• number of thalassemic patients with diabetes mellitus

  2 years

• control of diabetic thalassemic patients on insulin pump

  2 years

Study Arms (2)

daibetic thalassemic patients on SC insulin

ACTIVE COMPARATOR

A pilot study will be done on 20 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 (Khammar A et al., 2009). B-Therapeutic intervention: Thalassemia patients who proved to have diabetes according to the ADA criteria will be put on sc insulin

Device: insulin pump/CGMS

daibetic thalassemic patients on insulin pump

ACTIVE COMPARATOR

A pilot study will be done on 20 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 (Khammar A et B-Therapeutic intervention: Thalassemia patients who proved to have diabetes according to the ADA criteria will be put on insulin pump

Device: insulin pump/CGMS

Interventions

insulin pump/CGMS DEVICE

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).

daibetic thalassemic patients on SC insulin; daibetic thalassemic patients on insulin pump

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with B-thalassemia as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography ( HPLC) \& reticulocytic count ( Wethers, 2000; Fung et al., 2008).
• Patients with B-thalassemia aged less than 20 years.
• Patients with B-thalassemia on regular blood transfusion.
• Patients with B-thalassemia iron chelation therapy.
• Patients with s. ferritin \>1000(Soliman AT, et al.; 2013

You may not qualify if:

• Alpha thalassemia and sickle thalassemia patients.
• Patients with other endocrine abnormalities.
• Patients with family history of DM or other systemic illness.
• Patients with other hereditary diseases.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; beta-Thalassemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of pediatrics

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 19, 2018
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: July 19, 2018

Record last verified: 2018-07