Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03725657
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2018-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2018-10-28', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of steps through wrist accelerometer', 'timeFrame': 'three weeks', 'description': 'number of steps'}, {'measure': 'Measure of energy expenditure through wrist accelerometer', 'timeFrame': 'three weeks', 'description': 'kcal'}, {'measure': 'Measure of sleep expenditure through wrist accelerometer', 'timeFrame': 'three weeks', 'description': 'hours of sleep'}], 'secondaryOutcomes': [{'measure': 'Measure of glycemic control through glucometer', 'timeFrame': 'three weeks', 'description': 'mmol/L'}, {'measure': 'Measure of insulin dosage', 'timeFrame': 'three weeks', 'description': 'Units/kg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus', 'Hypoglycemia', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '21204959', 'type': 'RESULT', 'citation': 'Miller AR, Nebesio TD, DiMeglio LA. Insulin dose changes in children attending a residential diabetes camp. Diabet Med. 2011 Apr;28(4):480-6. doi: 10.1111/j.1464-5491.2010.03220.x.'}, {'pmid': '20811595', 'type': 'RESULT', 'citation': 'Kelly D, Hamilton JK, Riddell MC. Blood glucose levels and performance in a sports cAMP for adolescents with type 1 diabetes mellitus: a field study. Int J Pediatr. 2010;2010:216167. doi: 10.1155/2010/216167. Epub 2010 Aug 2.'}, {'pmid': '29541338', 'type': 'RESULT', 'citation': 'Bunn JA, Navalta JW, Fountaine CJ, Reece JD. Current State of Commercial Wearable Technology in Physical Activity Monitoring 2015-2017. Int J Exerc Sci. 2018 Jan 2;11(7):503-515. doi: 10.70252/NJQX2719. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity.\n\nThe investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.', 'detailedDescription': 'Background and Aims Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. Few studies confirm this hypothesis but none evaluated the correlation between steps, energy expenditure, sleep time and glycemic control and insulin dosage.\n\nMethods and Materials 60 patients with type 1 diabetes, aged 10 to 12 years, in multiinjection insulin therapy observed for 21 days (one week of camp, one week before and one after it). Food program was the same both at home and during the camp. They checked glycemia almost 5 times a day. A wrist accelerometer was used to evaluate sleep, steps and energy expenditure.\n\nAll data were recorded in a daily diary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric Type1Diabetes patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes onset \\> 1 year, multiple injection insulin therapy\n\nExclusion Criteria:\n\n* Physical impossibility to movement, food allergy'}, 'identificationModule': {'nctId': 'NCT03725657', 'acronym': 'inCamp', 'briefTitle': 'Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Using a Wrist-worn Accelerometer to Find a Correlation Between Exercise, Glycaemia and Insulin Dose in Type 1 Pediatric Patients, During a Camp: inCamp Study', 'orgStudyIdInfo': {'id': 'inCamp1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric', 'description': 'Pediatric Type1 Diabetes Mellitus patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'Centro di Diabetologia Pediatrica "G.Stoppoloni"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Angela Zanfardino', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}