Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 4:40 AM
Study NCT ID:
NCT02204657
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2014-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sharmsp13@gmail.com', 'phone': '60379492299', 'title': 'Dr Sharmila SP', 'organization': 'University Malaya Medical Centre'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'small sample size'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Continuous Glucose Monitoring System', 'description': 'Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.\n\nContinuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycemic Control by Measurement of HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitoring System', 'description': 'Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.\n\nContinuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.17', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 28 weeks until delivery', 'unitOfMeasure': 'mean percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Glucose Monitoring System', 'description': 'Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.\n\nContinuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '14'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 weeks until delivery', 'unitOfMeasure': 'episodes per patient', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Glucose Monitoring System', 'description': 'Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.\n\nContinuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '50 women with insulin-requiring gestational diabetes enrolled from the University of Malaya Medical CentreAntenatal Clinic between April 2013 to April 2015.\n\nWomen with overt diabetes or pregestational diabetes were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Glucose Monitoring System', 'description': 'Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.\n\nContinuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.80', 'spread': '4.53', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '4.93', 'groupId': 'BG001'}, {'value': '32.7', 'spread': '4.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Malaysia', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2014-07-28', 'resultsFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-23', 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Control by Measurement of HbA1c', 'timeFrame': 'From 28 weeks until delivery'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemia', 'timeFrame': '28 weeks until delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Continuous glucose monitoring in GDM'], 'conditions': ['Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '18818254', 'type': 'BACKGROUND', 'citation': 'Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.'}, {'pmid': '14738172', 'type': 'BACKGROUND', 'citation': 'Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. doi: 10.1080/jmf.14.4.256.260.'}, {'pmid': '18926784', 'type': 'BACKGROUND', 'citation': 'Yogev Y, Visser GH. Obesity, gestational diabetes and pregnancy outcome. Semin Fetal Neonatal Med. 2009 Apr;14(2):77-84. doi: 10.1016/j.siny.2008.09.002. Epub 2008 Oct 15.'}, {'pmid': '15951574', 'type': 'BACKGROUND', 'citation': 'Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.'}, {'pmid': '19154997', 'type': 'BACKGROUND', 'citation': 'Tan PC, Ling LP, Omar SZ. The 50-g glucose challenge test and pregnancy outcome in a multiethnic Asian population at high risk for gestational diabetes. Int J Gynaecol Obstet. 2009 Apr;105(1):50-5. doi: 10.1016/j.ijgo.2008.11.038. Epub 2009 Jan 19.'}, {'pmid': '21831468', 'type': 'BACKGROUND', 'citation': 'Balaji V, Balaji M, Anjalakshi C, Cynthia A, Arthi T, Seshiah V. Inadequacy of fasting plasma glucose to diagnose gestational diabetes mellitus in Asian Indian women. Diabetes Res Clin Pract. 2011 Oct;94(1):e21-3. doi: 10.1016/j.diabres.2011.07.008. Epub 2011 Aug 10.'}, {'pmid': '21976745', 'type': 'BACKGROUND', 'citation': 'Klonoff DC, Buckingham B, Christiansen JS, Montori VM, Tamborlane WV, Vigersky RA, Wolpert H; Endocrine Society. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 Oct;96(10):2968-79. doi: 10.1210/jc.2010-2756.'}, {'pmid': '15855600', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19797280', 'type': 'BACKGROUND', 'citation': 'Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.'}, {'pmid': '19875346', 'type': 'BACKGROUND', 'citation': 'Sathyapalan T, Mellor D, Atkin SL. Obesity and gestational diabetes. Semin Fetal Neonatal Med. 2010 Apr;15(2):89-93. doi: 10.1016/j.siny.2009.09.002. Epub 2009 Oct 28.'}, {'pmid': '29663517', 'type': 'DERIVED', 'citation': 'Paramasivam SS, Chinna K, Singh AKK, Ratnasingam J, Ibrahim L, Lim LL, Tan ATB, Chan SP, Tan PC, Omar SZ, Bilous RW, Vethakkan SR. Continuous glucose monitoring results in lower HbA1c in Malaysian women with insulin-treated gestational diabetes: a randomized controlled trial. Diabet Med. 2018 Aug;35(8):1118-1129. doi: 10.1111/dme.13649. Epub 2018 May 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if professional Continuous glucose monitoring improves glycemic control with less hypoglycaemia in insulin-requiring Gestational Diabetes Mellitus', 'detailedDescription': '1. OBJECTIVES\n\n 1. To determine if professional CGM improves glycemic control with less hypoglycaemia in insulin- requiring GDM\n 2. To determine if professional CGM use alters management of insulin-requiring GDM\n 3. To determine if professional CGM improves pregnancy outcomes in insulin-requiring GDM.\n 4. To determine patient attitudes toward CGMS.\n2. HYPOTHESES\n\n 1. Professional CGMS improves glycaemic control in women with insulin-requiring GDM with less hypoglycaemia\n 2. Professional CGM use will alter management of insulin-requiring GDM\n 3. Professional CGMS will reduce perinatal morbidity and mortality in patients with insulin- requiring GDM\n 4. Third trimester CGMS parameters will correlate better with perinatal outcomes compared with conventional measures of glycaemic control in pregnancy i.e. fructosamine/ A1c/ FBS/ 2hrs PP glucose\n\nSTUDY DESIGN\n\n* This is a prospective, open-label, randomized controlled trial. We plan to recruit 80 women with gestational diabetes at 28 weeks gestation or less from the UMMC antenatal clinic. These women should be insulin-naïve but require insulin therapy. 40 subjects (Group 1) will be selected to undergo professional CGM at weeks 28, 32, and week 36 and another 40 subjects individually matched with regards, to age, baseline A1c, BMI will be recruited to undergo usual antenatal care without CGMS (Group 2). The CGMS data will be uploaded and reviewed at weeks 29, 33, and 37 and changes made to the therapeutic regimen as required by the endocrinologist. All mothers will be required to measure their glucose levels at 7 standardized points in a day daily. These glucose readings will be recorded in a diary together with a food log. All subjects will also be required to keep a hypoglycaemia diary.\n* The primary outcomes will be glycaemic control in the third trimester and maternal hypoglycaemia. We also plan to assess changes to management made by the endocrinologist based on the additional information on glycemic control obtained from professional CGM use. We also plan to compare hypoglycaemia and hyperglycaemia detection rates using the CGMS and fingerstick methods of glucose evaluation. Patient satisfaction in both groups will also be assessed. Written and informed consent will be obtained in accordance with the principles of the Helsinki Declaration'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* women with gestational diabetes\n* aged \\>18 years\n* less than or equal to 28 weeks gestation of pregnancy\n* singleton pregnancy\n* insulin naive , but requiring insulin therapy\n\nExclusion Criteria:\n\n* pregestational type 1 or 2 diabetes mellitus\n* newly diagnosed overt diabetes in pregnancy ( HbA1c \\> 6.5)\n* hypothyroidism\n* Cushing's syndrome/ using exogenous steroids\n* chronic infection ( HIV, Hepatitis B/C, Tuberculosis)\n* any active chronic systemic disease ( except essential hypertension)\n* assisted conception\n* pregnancies with fetal anomalies / where imminent or preterm delivery is likely because of maternal disease ( besides gestational diabetes)"}, 'identificationModule': {'nctId': 'NCT02204657', 'briefTitle': 'The Effect of Continuous Glucose Monitoring on Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Effect of Professional Continuous Glucose Monitoring on Diabetes Management,Hypoglycemia and Glycemic Control in Insulin-requiring Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': '961.7'}, 'secondaryIdInfos': [{'id': 'PPUM/QSU/300-04/11', 'type': 'OTHER', 'domain': 'University Malaya Medical Centre, Malaysia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Glucose Monitoring System', 'description': 'Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.', 'interventionNames': ['Device: Continuous Glucose Monitoring System']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.'}], 'interventions': [{'name': 'Continuous Glucose Monitoring System', 'type': 'DEVICE', 'otherNames': ['iPro, Medtronic'], 'description': 'Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings', 'armGroupLabels': ['Continuous Glucose Monitoring System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Shireene R Vethakkan, MBBS,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Consultant Endocrinologist', 'investigatorFullName': 'Shireene Vethakkan', 'investigatorAffiliation': 'University of Malaya'}}}}