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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
OpT2mise: A randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetes - Research design and methods
Diabetes Technology and Therapeutics, Volume 16, No. 7, Year 2014
Notification
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Description
Background: In insulin-requiring type 2 diabetes patients, current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections (MDI) have not consistently provided achievement of optimal glycemic control. Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion (CSII) in these patients. The OpT2mise study is a multicenter, randomized, trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy. Subjects and Methods: Subjects were enrolled into a run-in period for optimization of their MDI insulin regimen. Subjects showing persistent hyperglycemia (glycated hemoglobin [HbA1c] ≥8% and ≤12%) were then randomly assigned to CSII or continuing an MDI regimen for a 6-month phase followed by a single crossover of the MDI arm, switching to CSII. The primary end point is the between-group difference in mean change in HbA1c from baseline to 6 months. Secondary end points include change in mean 24-h glucose values, area under the curve and time spent in hypoglycemia and hyperglycemia, measures of glycemic excursions, change in postprandial hyperglycemia, and evaluation of treatment satisfaction. Safety end points include hypoglycemia, hospital admissions, and emergency room visits. Results: When subject enrollment was completed in May 2013, 495 subjects had been enrolled in the study. The study completion for the primary end point is expected in January 2014. Conclusions: OpT2mise will represent the largest studied homogeneous cohort of type 2 diabetes patients with persistent hyperglycemia despite optimized MDI therapy. OpT2mise will help define the role of CSII in insulin intensification and define its safety, rate of hypoglycemia, patient adherence, and patient satisfaction. © Copyright 2014, Mary Ann Liebert, Inc. 2014.
Authors & Co-Authors
Aronson, Ronnie S.
Canada, Toronto
Lmc Healthcare
Cohen, Ohad
Israel, Tel Hashomer Tel Aviv
Chaim Sheba Medical Center Israel
Conget, Ignacio
Spain, Barcelona
Hospital Clinic Barcelona
Runzis, Sarah
Switzerland
Medtronic International Trading Sarl
Castaneda, Javier
Netherlands, Maastricht
Medtronic Bakken Research Center, Maastricht
De Portu, Simona
Switzerland
Medtronic International Trading Sarl
Lee, Scott
United States, Minneapolis
Medtronic, Inc.
Reznik, Yves
France, Caen
Hopital Cote de Nacre
Petrovski, Goran
North Macedonia, Skopje
University Clinic of Endocrinology
Kocsis, Győző
Hungary, Budapest
Peterfy Hospital
Lalić, Nebojša Malić
Serbia, Belgrade
Klinicki Centar Srbije
Tildesley, Hugh D.
Canada, Vancouver
Ers Endocrine Research Inc.
Priestman, B. A.
Canada, New Westminster
Diabetes Research Society
Metzger, M.
Israel, Jerusalem
Diabetes Clinic
Joyce, Carol
Canada, St John's
Memorial University of Newfoundland, Faculty of Medicine
Podgorski, Gracjan P.
South Africa, Port Elizabeth
Greenacres Hospital
Conway, R.
Canada
Canadian Centre for Research on Diabetes
Perkins, Bruce A.Y.
Canada, Toronto
Toronto General Hospital
Kooy, Adriaan
Netherlands, Bethesda
Bethesda Diabetes Research Center
Liebl, A.
Germany, Bad Heilbrunn
Fachklinik Bad Heilbrunn
Guerci, Bruno
France, Nancy
Chu de Nancy
Bode, Bruce W.
United States, Atlanta
Atlanta Diabetes Associates
Nardacci, E.
United States, Albany
Albany Medical College
Buchs, A.
Israel, Beer Yacov
Shamir Medical Center
Harmann-Boehm, I.
Israel, Beer Sheva
Soroka University Medical Center
Ross, Stuart A.
Canada, Toronto
Lmc Healthcare
Filetti, S.
Italy, Rome
Sapienza Università Di Roma
Yale, Jean François
Canada, Montreal
L'institut de Recherche du Centre Universitaire de Santé Mcgill
Distiller, Lawrence A.
South Africa, Johannesburg
Centre for Diabetes and Endocrinology
Weinstock, R. S.
United States, Syracuse
Suny Upstate Medical University
Zinger, J.
Israel, Petah Tiqwa
Rabin Medical Center Israel
Präger, Rudolf J.F.
Austria, Vienna
City of Vienna
Mosinzon, O.
Israel, Jerusalem
Hadassah University Medical Centre
Rose, Ludger
Germany, Munich
Institut Für Diabetesforschung
Giorgino, Francesco Libero
Italy, Bari
Università Degli Studi Di Bari Aldo Moro
Alwani, R.
Netherlands, Rotterdam
Ijsselland Ziekenhuis
Lieverse, L.
Netherlands, Veldhoven
Maxima Medical Center, Veldhoven
Bolli, G. B.
Italy, Perugia
Università Degli Studi Di Perugia
Moreau, F.
France, Strasbourg
Les Hôpitaux Universitaires de Strasbourg
Hanaire, H.
France, Toulouse
Hôpital Rangueil
Statistics
Citations: 40
Authors: 40
Affiliations: 38
Identifiers
Doi:
10.1089/dia.2013.0363
ISSN:
15209156
e-ISSN:
15578593
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study
Study Approach
Quantitative