Clinical trial · Observational

Comparing CGM and OGTT in Relation to Iron Overload Detected by Pancreas T2* MRI in High-Risk Hematology Group

Continuous Glucose Monitoring (CGM) Versus Oral Glucose Tolerance Test (OGTT) Versus T2* MRI Of The Pancreas In High-Risk Group (Hemoglobinopathies, Lymphoma & Acute Lymphoblastic Leukemia): A Comparative Study

NCT03141398CI-TRIAL-00028794CGMswithdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Due to issues with study design

Summary

Brief summary (as posted)

A prospective, observational, comparative study with no intervention.The objective of the study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C (Glycated Hemoglobin) and their relation to iron overload detected by T2\* MRI of the pancreas in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance and to study the different factors that may affect the glycemic control in these patients in relation to their results like the Dose of corticosteroids and chemotherapy in ALL and Hemoglobinopathies, Liver function in ALL and Hemoglobinopathies, and Serum ferritin in Hemoglobinopathies and their transfusion status. Using Validated Tools with Permission, the participants will be selected through probability (random) sampling method with expected subjects numbers ALL/L: 30-50, Thalassemia Major: 20, Sickle cell disease: 20.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Lymphoblastic Leukemia	Acute Lymphoblastic Leukemia	ONTOLOGY_EXACT	0.98
Hemoglobinopathies	—	UNRESOLVED	—
Iron Overload	—	UNRESOLVED	—
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Continuous Glucose Monitoring (CGM)	Diagnostic Test	—	UNRESOLVED
Oral Glucose Tolerance Test (OGTT)	Diagnostic Test	—	UNRESOLVED
T2* MRI of the Pancreas	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
High-Risk Group
description
The objective of the study to compare the efficiency of detecting glycemic abnormalities using Continuous Glucose Monitoring (CGMs) versus Oral Glucose Tolerance Test (OGTT) and HbA1C. versus T2\* MRI of the pancreas (T2\* MRI of the Pancreas) in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance and to study the different factors that may affect the glycemic control in these patients in relation to their results like the Dose of corticosteroids and chemotherapy in ALL and Hemoglobinopathies,Liver function in ALL and Hemoglobinopathies, and Serum ferritin in Hemoglobinopathies and their transfusion status.
interventionNames
1. Diagnostic Test: Continuous Glucose Monitoring (CGM)
2. Diagnostic Test: Oral Glucose Tolerance Test (OGTT)
3. Diagnostic Test: T2* MRI of the Pancreas

Primary outcomes (1)

measure
Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas
timeFrame
12 Months
description
Compare the efficiency of detecting glycemic abnormalities using CGMS versus OGTT vs HbA1C. in high-risk patients due to insulin deficiency (potential beta cell injury) and those with insulin resistance. Detect the prevalence of glycemic abnormalities detected in the same group of patients (high-risk patients) using three different modalities of testing (CGMS, OGTT, HbA1C)and T2\*MRI for pancreas

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 14 Years

Show eligibility criteria text

Inclusion Criteria:

* This study will include participants who are High-risk patients to develop glycemic abnormalities:

  1. Thalassemia major and SCD (beta cell toxicity and hepatic siderosis)
  2. ALL/L ( beta cell injury and hepatic injury due to chemotherapy, and insulin resistance due to corticosteroids)

Exclusion Criteria:

* Age \< 14 years;
* Other systemic diseases, renal disorders or malnourished;
* Patients and unwilling to participate in the study.

References

Publications (14)

BACKGROUNDGross TM, Bode BW, Einhorn D, Kayne DM, Reed JH, White NH, Mastrototaro JJ. Performance evaluation of the MiniMed continuous glucose monitoring system during patient home use. Diabetes Technol Ther. 2000 Spring;2(1):49-56. doi: 10.1089/152091500316737. PMID 11467320
BACKGROUNDPotts RO, Tamada JA, Tierney MJ. Glucose monitoring by reverse iontophoresis. Diabetes Metab Res Rev. 2002 Jan-Feb;18 Suppl 1:S49-53. doi: 10.1002/dmrr.210. PMID 11921430
BACKGROUNDBode B, Gross K, Rikalo N, Schwartz S, Wahl T, Page C, Gross T, Mastrototaro J. Alarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous monitoring system. Diabetes Technol Ther. 2004 Apr;6(2):105-13. doi: 10.1089/152091504773731285. PMID 15117576
BACKGROUNDHoi-Hansen T, Pedersen-Bjergaard U, Thorsteinsson B. Reproducibility and reliability of hypoglycaemic episodes recorded with Continuous Glucose Monitoring System (CGMS) in daily life. Diabet Med. 2005 Jul;22(7):858-62. doi: 10.1111/j.1464-5491.2005.01552.x. PMID 15975099
BACKGROUNDKlonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. doi: 10.2337/diacare.28.5.1231. No abstract available. PMID 15855600
BACKGROUNDNichols GA, Hillier TA, Brown JB. Progression from newly acquired impaired fasting glusose to type 2 diabetes. Diabetes Care. 2007 Feb;30(2):228-33. doi: 10.2337/dc06-1392. PMID 17259486
BACKGROUNDBarr EL, Zimmet PZ, Welborn TA, Jolley D, Magliano DJ, Dunstan DW, Cameron AJ, Dwyer T, Taylor HR, Tonkin AM, Wong TY, McNeil J, Shaw JE. Risk of cardiovascular and all-cause mortality in individuals with diabetes mellitus, impaired fasting glucose, and impaired glucose tolerance: the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab). Circulation. 2007 Jul 10;116(2):151-7. doi: 10.1161/CIRCULATIONAHA.106.685628. Epub 2007 Jun 18.