Iron OverloadCGMsNCT03141398

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

An observational study of Iron Overload and Hemoglobinopathies, run by Hamad Medical Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 years and older
Conditions the study is for: Iron Overload, Hemoglobinopathies, Lymphoma
What is being tested?: Continuous Glucose Monitoring (CGM), Oral Glucose Tolerance Test (OGTT) and T2* MRI of the Pancreas
Type of treatment: Pill or oral medicine
How many people: 0 participants
Where: No sites listed yet
Study dates: Aug 2017to Dec 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The targeted sample size is up to 100 patients (we aim to recruit approximately 70-100 cases based on the statistics from the outpatient clinics at NCCCR and the cancer registry data; over a period of 3 years). All cases of ALL, Lymphoma, Thalassemia and sickle cell disease diagnosed in HMC will be identified as subjects and they will be recruited based on informed consent and IRB approval.

Who may be able to join

This study will include participants who are High-risk patients to develop glycemic abnormalities:
Thalassemia major and SCD (beta cell toxicity and hepatic siderosis)
ALL/L ( beta cell injury and hepatic injury due to chemotherapy, and insulin resistance due to corticosteroids)

Who cannot join

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

About this study

Official title: 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

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: Iron Overload, Hemoglobinopathies, Lymphoma, Acute Lymphoblastic Leukemia
Being tested: Continuous Glucose Monitoring (CGM), Oral Glucose Tolerance Test (OGTT), T2* MRI of the Pancreas
Medical subject headings: Iron Overload, Hemoglobinopathies, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Continuous Glucose Monitoring (CGM)Diagnostic test
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)Diagnostic test
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 PancreasDiagnostic test
MRI [Magnetic resonance imaging] of the pancreas which is safe and takes around 30 minutes.

Study groups in NCT03141398
Study group	Role	What they receive
High-Risk Group		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. Receives: Diagnostic Test: Continuous Glucose Monitoring (CGM); Diagnostic Test: Oral Glucose Tolerance Test (OGTT); Diagnostic Test: T2* MRI of the Pancreas

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2017Dec 2018

First posted5 May 2017
Study startAug 2017 (estimated)
Primary completionAug 2018 (estimated)
Study completionDec 2018 (estimated)

Why it stopped: Due to issues with study design

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Iron OverloadStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03141398
Sponsor's protocol ID: 16298/16
Acronym: CGMs
Status last verified: May 2017
First submitted: 3 May 2017
Last updated: 26 Jul 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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. doi: 10.1089/152091500316737.
PubMed 11467320
Potts 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.
PubMed 11921430
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. doi: 10.1089/152091504773731285.
PubMed 15117576
Hoi-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.
PubMed 15975099
Klonoff 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.
PubMed 15855600
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. doi: 10.2337/dc06-1392.
PubMed 17259486
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. doi: 10.1161/CIRCULATIONAHA.106.685628. Epub 2007 Jun 18.
PubMed 17576864
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. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PubMed 9686693
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.
PubMed 15618111
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.
PubMed 24944918
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.
PubMed 21764709
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.
PubMed 24376762
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.
PubMed 19764578
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.
PubMed 23876034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingPhase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
Hemolytic Anemia, Thalassemia
Active, not recruitingPhase 2
Treatment of Hemochromatosis
Hemochromatosis

All Iron Overload trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03141398
Acronym / sponsor ID: CGMs / 16298/16
Conditions: Iron Overload, Hemoglobinopathies, Lymphoma, Acute Lymphoblastic Leukemia
Study type: Observational
Recruitment status: WithdrawnReason stopped: Due to issues with study design
Enrolment: 0 participants (actual)
Lead sponsor: Hamad Medical CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2017 (estimated)
Primary completion: Aug 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 5 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
High-Risk Group	–	Diagnostic Test: Continuous Glucose Monitoring (CGM), Diagnostic Test: Oral Glucose Tolerance Test (OGTT), Diagnostic Test: T2* MRI of the PancreasThe 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.

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The targeted sample size is up to 100 patients (we aim to recruit approximately 70-100 cases based on the statistics from the outpatient clinics at NCCCR and the cancer registry data; over a period of 3 years). All cases of ALL, Lymphoma, Thalassemia and sickle cell disease diagnosed in HMC will be identified as subjects and they will be recruited based on informed consent and IRB approval.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Diagnostic test	High-Risk Group
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.	Diagnostic test	High-Risk Group
T2* MRI of the PancreasMRI [Magnetic resonance imaging] of the pancreas which is safe and takes around 30 minutes.	Diagnostic test	High-Risk Group

Primary outcome

Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas
Time frame: 12 Months
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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
Background: PubMed 11467320Gross 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.
Background: PubMed 11921430Potts 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.
Background: PubMed 15117576Bode 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.
Background: PubMed 15975099Hoi-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.
Background: PubMed 15855600Klonoff 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.
Background: PubMed 17259486Nichols 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.
Background: PubMed 17576864Barr 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.
Background: PubMed 9686693Alberti 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. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
Background: PubMed 15618111American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.
Background: PubMed 24944918Soliman 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.
Background: PubMed 21764709Chen 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.
Background: PubMed 24376762Zhou 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.
Individual participant dataSharing planned: Undecided

Related trials for Iron Overload

Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingPhase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
Hemolytic Anemia, Thalassemia
Active, not recruitingPhase 2
Treatment of Hemochromatosis
Hemochromatosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed Yassin principal investigator

Hamad Medical Corporation

Questions about this trial

What is this clinical trial studying?

An observational study of Iron Overload and Hemoglobinopathies, run by Hamad Medical Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficiency of continuous glucose monitoring compared to oral glucose tolerance and MRI of the Pancreas (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03141398, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.