Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT01088451
Status:
UNKNOWN
Last Update Posted:
2010-03-17
First Post:
2010-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-16', 'studyFirstSubmitDate': '2010-02-11', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in mean blood glucose concentrations and the pattern of fluctuation on control and study days; and changes in the glycated hemoglobin A1c after the study period. Occurrence of side effects especially hypoglycemic episodes.', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'The difference in postprandial areas under the curve when comparing conventional therapy and experimental combined prandial insulin therapy in the 5 to 6 hours following meal ingestion, taking into account the glycemic index profile of the meal.', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 1', 'Prandial Glycemia', 'Rapid Acting Insulin Analogue', 'Human Insulin'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '12610053', 'type': 'BACKGROUND', 'citation': 'Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care. 2003 Mar;26(3):881-5. doi: 10.2337/diacare.26.3.881.'}, {'pmid': '12081850', 'type': 'BACKGROUND', 'citation': 'Jenkins DJ, Kendall CW, Augustin LS, Franceschi S, Hamidi M, Marchie A, Jenkins AL, Axelsen M. Glycemic index: overview of implications in health and disease. Am J Clin Nutr. 2002 Jul;76(1):266S-73S. doi: 10.1093/ajcn/76/1.266S.'}, {'pmid': '15182401', 'type': 'BACKGROUND', 'citation': 'Flint A, Moller BK, Raben A, Pedersen D, Tetens I, Holst JJ, Astrup A. The use of glycaemic index tables to predict glycaemic index of composite breakfast meals. Br J Nutr. 2004 Jun;91(6):979-89. doi: 10.1079/bjn20041124.'}, {'pmid': '14652382', 'type': 'BACKGROUND', 'citation': 'Monro J. Redefining the glycemic index for dietary management of postprandial glycemia. J Nutr. 2003 Dec;133(12):4256-8. doi: 10.1093/jn/133.12.4256.'}, {'pmid': '19079901', 'type': 'BACKGROUND', 'citation': 'Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.'}, {'pmid': '10205584', 'type': 'BACKGROUND', 'citation': 'Axelsen M, Wesslau C, Lonnroth P, Arvidsson Lenner R, Smith U. Bedtime uncooked cornstarch supplement prevents nocturnal hypoglycaemia in intensively treated type 1 diabetes subjects. J Intern Med. 1999 Mar;245(3):229-36. doi: 10.1046/j.1365-2796.1999.00432.x.'}, {'pmid': '18509207', 'type': 'BACKGROUND', 'citation': "O'Connell MA, Gilbertson HR, Donath SM, Cameron FJ. Optimizing postprandial glycemia in pediatric patients with type 1 diabetes using insulin pump therapy: impact of glycemic index and prandial bolus type. Diabetes Care. 2008 Aug;31(8):1491-5. doi: 10.2337/dc08-0306. Epub 2008 May 28."}, {'pmid': '19175902', 'type': 'BACKGROUND', 'citation': 'Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.'}, {'pmid': '9203460', 'type': 'BACKGROUND', 'citation': 'Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997 Jul;20(7):1183-97. doi: 10.2337/diacare.20.7.1183. No abstract available.'}, {'pmid': '18547233', 'type': 'BACKGROUND', 'citation': 'Bowden SA, Duck MM, Hoffman RP. Young children (<5 yr) and adolescents (>12 yr) with type 1 diabetes mellitus have low rate of partial remission: diabetic ketoacidosis is an important risk factor. Pediatr Diabetes. 2008 Jun;9(3 Pt 1):197-201. doi: 10.1111/j.1399-5448.2008.00376.x.'}, {'pmid': '15855602', 'type': 'BACKGROUND', 'citation': 'Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.'}, {'pmid': '12081815', 'type': 'BACKGROUND', 'citation': 'Foster-Powell K, Holt SH, Brand-Miller JC. International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr. 2002 Jul;76(1):5-56. doi: 10.1093/ajcn/76.1.5.'}, {'pmid': '15647580', 'type': 'BACKGROUND', 'citation': 'Hirsch IB. Insulin analogues. N Engl J Med. 2005 Jan 13;352(2):174-83. doi: 10.1056/NEJMra040832. No abstract available.'}, {'pmid': '11909787', 'type': 'BACKGROUND', 'citation': 'Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. 2002 Mar 23;324(7339):705. doi: 10.1136/bmj.324.7339.705.'}]}, 'descriptionModule': {'briefSummary': 'Postprandial glycemic control is essential for diabetes compensation. Insulin pump therapy control blood glucose released in response to both high and low glycemic index carbohydrates in a mixed diet using normal, square and dual-wave boluses. The investigators hypothesize a mixture of rapid insulin analogue and human insulin has the same effect.\n\nThis pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by combined prandial application of insulin aspart and human insulin. Mixed-meals with high, both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios of analogue to human insulin mixture. Subjects are followed by continuous glucose monitor for six days (Phase One), changing between the experimental or their standard protocol for insulin injection on consecutive days. The outcome was measured by comparing average glycemia and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable salad. The next three-to-four week period of therapy was evaluated by glycated hemoglobin before and after the intervention (Phase Two).\n\nExpected outcomes are postprandial and complex improvement of diabetes control, similarly to the insulin pump therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* pubertal children, adolescents, young adults able to follow instructions, regardless of their long-time compliance\n* willing to undertake a prandial application of two kinds of insulin using two standard insulin applicators.\n* willing to complete detailed meal, insulin and/or combination insulin and hypoglycemia diary throughout the study.\n\nExclusion criteria:\n\n* acute illness and celiac disease, but not euthyroid autoimmune thyroiditis, defined as thyroid stimulating hormone (TSH)\\<4 mIU/l.'}, 'identificationModule': {'nctId': 'NCT01088451', 'acronym': 'CPIT', 'briefTitle': 'Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia', 'orgStudyIdInfo': {'id': '200912S24'}, 'secondaryIdInfos': [{'id': 'MZO00179906-01', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Hradec Králové'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Combined prandial insulin therapy (CPIT)', 'type': 'DRUG', 'description': "Combined prandial insulin therapy (CPIT) applies individual combination of rapid insulin analogue and human insulin according subject's individual estimation of the type of carbohydrates in concrete mixed-meal, based on thorough education. In this study subjects use two applicators, giving two injections before main meals as per basal-bolus therapy. Insulin aspart (Novorapid, Novo Nordisk) and human insulin (Actrapid, Novo Nordisk) are used."}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'David Neumann/Principal Investigator', 'oldOrganization': 'University Hospital Hradec Králové'}}}}