Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 12:22 AM
Study NCT ID:
NCT01741467
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in blood glucose', 'timeFrame': 'baseline, 18 months', 'description': 'Changes in A1c and fasting blood glucose over time and between the intervention and control groups.'}], 'secondaryOutcomes': [{'measure': 'Impact of lifestyle changes', 'timeFrame': 'baseline, 18 months', 'description': 'Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.'}, {'measure': 'Changes in Glucose dynamics', 'timeFrame': 'baseline, 18 months', 'description': 'Comparison of intervention and control group on standard measures of glucose dynamics.'}, {'measure': 'Differences in blood pressure.', 'timeFrame': 'baseline, 18 months', 'description': 'Objective comparison between the control and experimental group in changes in blood pressure.'}, {'measure': 'Differences in lipids.', 'timeFrame': 'baseline, 18 months', 'description': 'Objective comparison between the control group and the experimental group on changes in lipids.'}, {'measure': 'Differences in weight', 'timeFrame': 'baseline, 18 months', 'description': 'Objective comparison between the control group and the experimental group on changes in weight.'}, {'measure': 'Changes in medication use', 'timeFrame': 'baseline, 18 months', 'description': 'An objective comparison between the control and experimental group on changes in medication use.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pre-diabetes', 'Impaired Glucose Tolerance']}, 'referencesModule': {'references': [{'pmid': '17257275', 'type': 'BACKGROUND', 'citation': 'Diabetes Prevention Program Research Group. The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the Diabetes Prevention Program. Diabet Med. 2007 Feb;24(2):137-44. doi: 10.1111/j.1464-5491.2007.02043.x.'}, {'pmid': '11832527', 'type': 'BACKGROUND', 'citation': 'Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.'}, {'pmid': '16249558', 'type': 'BACKGROUND', 'citation': 'Yamaoka K, Tango T. Efficacy of lifestyle education to prevent type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2005 Nov;28(11):2780-6. doi: 10.2337/diacare.28.11.2780.'}, {'pmid': '18261504', 'type': 'BACKGROUND', 'citation': 'Salpeter SR, Buckley NS, Kahn JA, Salpeter EE. Meta-analysis: metformin treatment in persons at risk for diabetes mellitus. Am J Med. 2008 Feb;121(2):149-157.e2. doi: 10.1016/j.amjmed.2007.09.016.'}, {'pmid': '21428766', 'type': 'BACKGROUND', 'citation': 'DeFronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Hodis HN, Kitabchi AE, Mack WJ, Mudaliar S, Ratner RE, Williams K, Stentz FB, Musi N, Reaven PD; ACT NOW Study. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011 Mar 24;364(12):1104-15. doi: 10.1056/NEJMoa1010949.'}, {'pmid': '16627376', 'type': 'BACKGROUND', 'citation': 'Chiasson JL. Acarbose for the prevention of diabetes, hypertension, and cardiovascular disease in subjects with impaired glucose tolerance: the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial. Endocr Pract. 2006 Jan-Feb;12 Suppl 1:25-30. doi: 10.4158/EP.12.S1.25.'}, {'pmid': '17054235', 'type': 'BACKGROUND', 'citation': 'Van de Laar FA, Lucassen PL, Akkermans RP, Van de Lisdonk EH, De Grauw WJ. Alpha-glucosidase inhibitors for people with impaired glucose tolerance or impaired fasting blood glucose. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005061. doi: 10.1002/14651858.CD005061.pub2.'}, {'pmid': '18779236', 'type': 'BACKGROUND', 'citation': "Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8."}, {'pmid': '21335621', 'type': 'BACKGROUND', 'citation': 'Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011 Apr;34(4):795-800. doi: 10.2337/dc10-1989. Epub 2011 Feb 19.'}, {'pmid': '19675193', 'type': 'BACKGROUND', 'citation': 'Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Bode B, Beck RW, Xing D, Gilliam L, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Tamborlane WV, Weinzimer S, Wolpert H. Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2047-9. doi: 10.2337/dc09-0846. Epub 2009 Aug 12.'}, {'pmid': '22100963', 'type': 'BACKGROUND', 'citation': 'Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.'}, {'pmid': '22442395', 'type': 'BACKGROUND', 'citation': 'Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30. doi: 10.2337/dc11-1468.'}, {'pmid': '21193625', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc11-S011. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.', 'detailedDescription': 'The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a "wash-in" phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Newly diagnosed with pre-diabetes (within the previous 6 months) with a FPG of \\> or = 110-125mg/dl or an A1c \\> or = 6% - 6.4%\n* Able to independently measure and read finger stick blood glucose levels\n* Willing to wear the CGM device for up to 12 weeks during the study period\n* Willing to test blood sugar by fingerstick twice per day while wearing the CGM\n* DEERS eligible\n\nExclusion Criteria:\n\n* Using medication for pre-diabetes\n* Women who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method; all female subjects will undergo pregnancy testing via a serum HcG with their initial blood testing.\n* Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study.\n* Active Duty service members likely to be deployed during the 18-month study period.'}, 'identificationModule': {'nctId': 'NCT01741467', 'acronym': 'CGM PreDM', 'briefTitle': 'The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes', 'orgStudyIdInfo': {'id': '369196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT-CGM', 'description': 'Patients using the RT-CGM for the intervention portion of the study.', 'interventionNames': ['Behavioral: RT-CGM']}], 'interventions': [{'name': 'RT-CGM', 'type': 'BEHAVIORAL', 'description': 'Dexcom Seven+', 'armGroupLabels': ['RT-CGM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889-5600', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Robert Vigersky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed National Military Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'DexCom, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Diabetes Institute', 'investigatorFullName': 'Alicia L. Warnock', 'investigatorAffiliation': 'Walter Reed National Military Medical Center'}}}}