Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-04 @ 8:01 PM
Study NCT ID:
NCT03871660
Status:
UNKNOWN
Last Update Posted:
2019-05-28
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flash Glucose Measurement in Patients on Total Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-24', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperglycaemia', 'timeFrame': '14 days', 'description': 'Measurements of hyperglycaemia through interstitial glucose levels in patients on a TPN regime'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Parenteral Nutrition'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'IV nutrition is a means of providing all the nutritional requirements of people who have severe bowel disease. At least 10% of people on longer term IV nutrition also have diabetes and IV nutrition includes delivering glucose directly to large veins. Unsurprisingly this causes elevated blood glucose levels, particularly in people with diabetes. This can make treatment of hyperglycaemia more challenging. As a result this study aims to use a flash glucose monitoring device, the FreeStyle Libre pro, to investigate what happens to glucose levels in patients receiving IV nutrition. We will look at this trend in 5 patients with diabetes and 5 patients without diabetes receiving IV nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants receiving TPN in Leeds with or without diabetes\n\nExclusion Criteria:\n\n* Patients not receiving TPN\n* Patients who do not speak English\n* Patients who are unable to give consent'}, 'identificationModule': {'nctId': 'NCT03871660', 'briefTitle': 'Flash Glucose Measurement in Patients on Total Parenteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).', 'orgStudyIdInfo': {'id': 'LeedsNHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with diabetes on TPN', 'description': 'Glucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN.', 'interventionNames': ['Device: FreeStyle Libre Pro']}, {'type': 'OTHER', 'label': 'Patients without diabetes on TPN', 'description': 'Glucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN.', 'interventionNames': ['Device: FreeStyle Libre Pro']}], 'interventions': [{'name': 'FreeStyle Libre Pro', 'type': 'DEVICE', 'description': 'Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.', 'armGroupLabels': ['Patients with diabetes on TPN', 'Patients without diabetes on TPN']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Michael W Mansfield, BMBCh, BA (hons)', 'role': 'CONTACT', 'email': 'michael.mansfield@nhs.net', 'phone': '01132066963'}], 'facility': 'Diabetes, Endocrinology and General Medcine Department St James Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Michael W Mansfield, BM BCh, BA (hons)', 'role': 'CONTACT', 'email': 'michael.mansfield@nhs.net', 'phone': '01132066963'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}