Received: 12 November 2016
Revised: 27 March 2017
Accepted: 30 March 2017
DOI: 10.1111/dom.12960
BRIEF REPORT
Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial Muriel Metzger MD1 | Javier Castañeda MSc2 | Yves Reznik MD3 | Francesco Giorgino MD4 | Ignacio Conget MD5 | Ronnie Aronson MD6 | Simona de Portu MSc7 | Sarah Runzis MD7 | Scott W. Lee MD8 | Ohad Cohen MD9 1
Diabetes Clinic, Clalit Health Services, Jerusalem, Israel
This analysis investigated factors associated with the decrease in HbA1c in patients receiving
2
continuous subcutaneous insulin infusion (CSII) in the OpT2mise randomized trial. In this study,
Medtronic Bakken Research Center, Maastricht, The Netherlands 3
Department of Endocrinology, University of Caen Côte de Nacre Regional Hospital Center, Caen, France 4
Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro, Bari, Italy 5
Diabetes Unit, Endocrinology and Nutrition Department, University Hospital Clinic, Barcelona, Spain 6 LMC Diabetes & Endocrinology, Toronto, Ontario, Canada 7
Medtronic International Trading Sàrl, Tolochenaz, Switzerland 8
Medtronic Diabetes, Northridge, California
patients with type 2 diabetes and HbA1c >8% following multiple daily injections (MDI) optimization were randomized to receive CSII (n = 168) or MDI (n = 163) for 6 months. Patientrelated and treatment-related factors associated with decreased HbA1c in the CSII arm were identified by univariate and multivariate analyses. CSII produced a significantly greater reduction in HbA1c than MDI, and the treatment difference increased with baseline HbA1c. In the CSII arm, the only factors significantly associated with decreased HbA1c were higher baseline HbA1c (P < .001), geographical region (P < .001), higher educational level (P = .012), higher total cholesterol level (P = .002), lower variability of baseline glucose values on continuous glucose monitoring (P < .001) and the decrease in average fasting self-monitored blood glucose at 6 months (P < .001). These findings suggest that CSII offers an option to improve glycemic control in a broad range of patients with type 2 diabetes in whom control cannot be achieved with MDI. OpT2mise ClinicalTrials.gov number: NCT01182493 (https://clinicaltrials.gov/). KEYWORDS
9
Institute of Endocrinology, Chaim Sheba Medical Center, Tel Hashomer, Israel Correspondence Ohad Cohen, Institute of Endocrinology, Chaim Sheba Medical Center, Tel Hashomer, Israel 52621. Email:
[email protected]
blood glucose self-monitoring, glycated hemoglobin, insulin infusion systems, insulin therapy, multiple daily injections, type 2 diabetes mellitus
Funding information This study was sponsored by Medtronic International Trading Sàrl, Tolochenaz, Switzerland.
1 | I N T RO D UC T I O N
trial, which compared CSII with multiple daily injections (MDI) in patients with type 2 diabetes and glycated hemoglobin (HbA1c) ≥8%
Continuous subcutaneous insulin infusion (CSII) has been successfully
despite optimization of MDI therapy, the mean reduction in HbA1c
used in the treatment of type 1 diabetes for more than a decade,1–3 but
levels was 0.7% greater with CSII than with MDI therapy (P < .0001),
the experience in clinical trials in patients with type 2 diabetes has hith-
55% achieving a target of HbA1c 9% were −0.4% 0.9% (P = .004), and −1.0% 1.4% (P < .001), respectively.
The OpT2mise trial demonstrated the superiority of CSII therapy, compared with MDI, in significantly reducing HbA1c in metformin-
TABLE 1
Final multivariate model for baseline factors associated with decrease in HbA1c in the CSII therapy group Regression model coefficient
4 | DI SCU SSION
P
treated patients with type 2 diabetes who do not reach glycemic targets after optimization of basal-bolus insulin therapy.8,9 The present analysis was performed to identify the baseline patient characteristics most strongly associated with this improved outcome, because such
Baseline HbA1c level
−0.96
