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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03141398
Other study ID # 16298/16
Secondary ID
Status Withdrawn
Phase N/A
First received May 3, 2017
Last updated July 24, 2017
Start date August 2017
Est. completion date December 2018

Study information

Verified date May 2017
Source Hamad Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Continuous Glucose Monitoring (CGM)
Where a pager-sized device fixed to the patient's forearm by a diabetic educator and it will connect to his/her body with the sensor, which measures blood glucose for three days. Patients' may experience little pain from needle prick when a sensor is introduced.
Oral Glucose Tolerance Test (OGTT)
Oral glucose tolerance test requires the patient to be fasting and checking of blood sugar after 8 to 10 hours overnight fasting the blood sugar will be checked three times When you arrive to the lab then twice one hour, apart you can have pain due to needle prick or little bleeding at the puncture site.
T2* MRI of the Pancreas
MRI [Magnetic resonance imaging] of the pancreas which is safe and takes around 30 minutes.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hamad Medical Corporation

References & Publications (14)

Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. — View Citation

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. — View Citation

Barr 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. Epub 2007 Jun 18. — View Citation

Bode 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. — View Citation

Chen T, Xu F, Su JB, Wang XQ, Chen JF, Wu G, Jin Y, Wang XH. Glycemic variability in relation to oral disposition index in the subjects with different stages of glucose tolerance. Diabetol Metab Syndr. 2013 Jul 23;5:38. doi: 10.1186/1758-5996-5-38. eCollection 2013. — View Citation

Chen Z, Shen J, Xu LL, Fu XJ, Li JM, Ma YY. [Accuracy of a continuous glucose monitoring system in detection of blood glucose during oral glucose tolerance test]. Nan Fang Yi Ke Da Xue Xue Bao. 2011 Jun;31(7):1256-8. Chinese. — View Citation

Gross 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. — View Citation

He LP, Wang C, Zhong L, Yang YZ, Long Y, Zhang XX, Shu SQ, Yu HL, Yu TT, Wang WP, Wang Y, Ran XW. [Glycemic excursions in people with normal glucose tolerance in Chengdu]. Sichuan Da Xue Xue Bao Yi Xue Ban. 2009 Jul;40(4):704-7. Chinese. — View Citation

Høi-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. — View Citation

Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes therapy. Diabetes Care. 2005 May;28(5):1231-9. Review. — View Citation

Nichols GA, Hillier TA, Brown JB. Progression from newly acquired impaired fasting glusose to type 2 diabetes. Diabetes Care. 2007 Feb;30(2):228-33. Erratum in: Diabetes Care. 2008 Dec;31(12):2414. — View Citation

Potts RO, Tamada JA, Tierney MJ. Glucose monitoring by reverse iontophoresis. Diabetes Metab Res Rev. 2002 Jan-Feb;18 Suppl 1:S49-53. Review. — View Citation

Soliman A, DeSanctis V, Yassin M, Elalaily R, Eldarsy NE. Continuous glucose monitoring system and new era of early diagnosis of diabetes in high risk groups. Indian J Endocrinol Metab. 2014 May;18(3):274-82. doi: 10.4103/2230-8210.131130. Review. — View Citation

Zhou J, Mo Y, Li H, Ran X, Yang W, Li Q, Peng Y, Li Y, Gao X, Luan X, Wang W, Xie Y, Jia W. Relationship between HbA1c and continuous glucose monitoring in Chinese population: a multicenter study. PLoS One. 2013 Dec 23;8(12):e83827. doi: 10.1371/journal.pone.0083827. eCollection 2013. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas 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 12 Months
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