Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-29 @ 12:50 PM
Study NCT ID:
NCT00973492
Status:
UNKNOWN
Last Update Posted:
2009-09-09
First Post:
2009-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-08', 'studyFirstSubmitDate': '2009-09-07', 'studyFirstSubmitQcDate': '2009-09-08', 'lastUpdatePostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS', 'timeFrame': '0, 3 months, 6 months'}], 'secondaryOutcomes': [{'measure': 'anti-transglutaminase and anti-endomysium antibodies', 'timeFrame': '0 months, 6 months'}, {'measure': 'dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha', 'timeFrame': '0 months, 6 months'}, {'measure': 'anti-insulin antibodies by ELISA', 'timeFrame': '0 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'functional insulinotherapy'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24581956', 'type': 'DERIVED', 'citation': 'Benhamou PY, Somers F, Lablanche S, Debaty I, Borel AL, Nasse L, Stanke-Labesque F, Faure P, Boizel R, Halimi S. Impact of flexible insulin therapy on blood glucose variability, oxidative stress and inflammation in type 1 diabetic patients: the VARIAFIT study. Diabetes Metab. 2014 Sep;40(4):278-83. doi: 10.1016/j.diabet.2014.01.004. Epub 2014 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.\n\nSo, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes.\n\nThis trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.', 'detailedDescription': 'This is a prospective, open, non-controlled study with an individual benefit for the participant. This study is designed to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.\n\nAll 30 patients with type 1 diabetes attended a 4-day functional insulinotherapy class, taught by 2 nurses, 2 dieticians and 2 physicians. The participants were recruited among metabolically stable patients who had already been prescribed functional insulinotherapy.\n\nTo assess the impact of functional insulinotherapy on blood glucose variability, HbA1c will be measured at 0, 3 months and 6 months along with 4 blood glucose variability indicators: MAGE, ADRR, LI and LBGI.\n\nThis trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress. Therefore, a measure of insulin antibodies by ELISA at baseline. At baseline and 6 months, LTE4, TXB2, 8-iso-PGF2alpha, anti-transglutaminase and anti-endomysium antibodies will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have been prescribed functional insulinotherapy at University Hospital Grenoble', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes with pump or multi-injection treatment and attending a functional insulinotherapy class\n* Social Security membership or benefit from Social Security\n* Informed consent, with a signed and approved form\n\nExclusion Criteria:\n\n* Underage patient, major patient under guardianship or protected by the Law\n* Pregnant, parturient or breastfeeding woman\n* Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law\n* Antecedents of pathologies causing diabetes instability (coeliac disease, gastroparesis, non-balanced psychiatric pathology) and not optimally treated, acute pathology less than 3 months ago (infectious, cardio-vascular, metabolic), pregnancy'}, 'identificationModule': {'nctId': 'NCT00973492', 'acronym': 'VARIAFIT', 'briefTitle': 'Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition"}, 'officialTitle': 'Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2007-A00903-50'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with functional insulinotherapy', 'description': 'There is only one group in this study. The participants will attend a functional insulinotherapy class.', 'interventionNames': ['Other: functional insulinotherapy class']}], 'interventions': [{'name': 'functional insulinotherapy class', 'type': 'OTHER', 'description': 'The functional insulinotherapy class lasts for 4 days. It is taught by 2 nurses, 2 dieticians and 2 physicians to 6 to 10 patients.\n\nOn day 1, patients describe their difficulties with diabetes. Fast-acting insulin scales are elaborated from preprandial and postprandial blood glucose levels. At dinner, patients start a 24-hour glucose-fasting period to evaluate their need for basal insulin. Meals contain virtually no carbohydrates. Correcting doses of insulin are administered if preprandial glycemia is over 1.50 g/l or postprandial glycemia is over 2 g/l. Blood glucose levels must stay within normal values during the whole 24-hour period.\n\nCarbohydrate management is taught during meals and every afternoon through workshops about dietetics. Patients also learn how to deal with hypoglycaemia, hyperglycaemia and physical activity.\n\nA one-day follow-up takes place 3 months later.', 'armGroupLabels': ['patients with functional insulinotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Service de Diabétologie du Pr Halimi, CHU', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Pierre-Yves Benhamou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pr Pierre-Yves Benhamou', 'oldOrganization': 'University Hospital Grenoble'}}}}