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

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ClinicalTrials.gov Identifier: NCT03591900
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Amira Abd el moneam, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Diabetes Prediabetes B-Thalassemia Device: insulin pump/CGMS Not Applicable

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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of Continuous Blood Glucose Monitoring Method for Detection of Alterations in Glucose Homeostasis in Beta Thalassemia Patients
Study Start Date : April 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Active Comparator: daibetic thalassemic patients on SC insulin

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

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).


Active Comparator: daibetic thalassemic patients on insulin pump

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

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).





Primary Outcome Measures :
  1. number of thalassemic patients with impaired glucose tolerance [ Time Frame: 2 years ]
    to find out the number of patients with thalassemia major having impaired glucose tolerance


Secondary Outcome Measures :
  1. number of thalassemic patients with diabetes mellitus [ Time Frame: 2 years ]
    to find out the number of patients with thalassemia major having diabetes mellitus

  2. control of diabetic thalassemic patients on insulin pump [ Time Frame: 2 years ]
    to compare the use of conventional insulin therapy to insulin pump in diabetic thalassemic patients



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Layout table for eligibility information
Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Patients with B-thalassemia aged less than 20 years.
  3. Patients with B-thalassemia on regular blood transfusion.
  4. Patients with B-thalassemia iron chelation therapy.
  5. Patients with s. ferritin >1000(Soliman AT, et al.; 2013

Exclusion Criteria:

  1. Alpha thalassemia and sickle thalassemia patients.
  2. Patients with other endocrine abnormalities.
  3. Patients with family history of DM or other systemic illness.
  4. Patients with other hereditary diseases.
Layout table for additonal information
Responsible Party: Amira Abd el moneam, Professor of pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT03591900    
Other Study ID Numbers: Pediatric hospital ASU
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Keywords provided by Amira Abd el moneam, Ain Shams University:
early diabetes
prediabetes
continuous glucose monitoring system
detection
Additional relevant MeSH terms:
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Thalassemia
Prediabetic State
Glucose Intolerance
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs