OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)
- Registration Number
- NCT01182493
- Lead Sponsor
- Medtronic Diabetes
- Brief Summary
The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).
- Detailed Description
The type of study is interventional post-market release. All the devices under investigation have CE mark, and are used within intended use.
This study has been designed to be prospective randomized controlled with a single-arm cross-over in the continuation phase.
Four hundred type 2 Multiple Daily Injections (MDI) treated patients will undergo a screening (run-in) phase of 8 weeks. The aim of the screening phase is to eliminate the study effect that might result in a decrease of HbA1c and to make sure that patients, who are failing current MDI therapy, are selected.
After this screening phase, eligible patients will be randomised to receive either Continuous Subcutaneous Insulin Infusion (CSII) treatment or continue MDI treatment. The study phase is a 6-months phase with 2-arms parallel design.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Pump Treatment Insulin Pump (Medtronic Minimed Paradigm® VEO) Patients will get an insulin pump
- Primary Outcome Measures
Name Time Method Between Group Difference in HbA1c When Comparing CSII to MDI baseline and 6 months To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline
- Secondary Outcome Measures
Name Time Method Change in Glycemic Variability - AUC in Hyper (≥180mg/dL) 6 months Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline
Change in Body Weight 6 months Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight
Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ) 6 months Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores
Safety - Diabetic Ketoacidosis Incidence 6 Months Diabetic Ketoacidosis incidence during the study
Change in Glycemic Variability - AUC in Hypo (≤70mg/dL) 6 months Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline
Safety - Severe Hypoglycemia Incidence 6 months Severe hypoglycemia incidence during the study
Trial Locations
- Locations (36)
Albany Medical College
🇺🇸Albany, New York, United States
Health Science Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
McGill University, McGill Nutrition and Food Science Centre
🇨🇦Montreal, Quebec, Canada
Diabetic Clinic
🇮🇱Jerusalem, Israel
Clinic for Endocrinology, Diabetes and Metabolic Diseases
🇷🇸Belgrade, Serbia
CHU - Ste Marguerite
🇫🇷Marseille, France
LMC Endocrinology Centre
🇨🇦Oakville, Ontario, Canada
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
CHU Strasbourg
🇫🇷Strasbourg, France
University La Sapienza - Policlinico
🇮🇹Roma, Italy
Fachklinik Bad Heilbrunn
🇩🇪Bad Heilbrunn, Germany
Toronto General Hsopital
🇨🇦Toronto, Ontario, Canada
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Università degli Studi di Bari - Policlinico Universitario
🇮🇹Bari, Italy
Hopital Lapeyronie
🇫🇷Montpellier, France
Clinical Professor Department of Medicine University of Calgary
🇨🇦Calgary, Alberta, Canada
416-1033 Davie St
🇨🇦Vancouver, British Columbia, Canada
Centre for Diabetes and Endocrinology
🇿🇦Johannesburg, South Africa
City hopital Vienna-Hieting
🇦🇹Vienna, Austria
Assaf- Harofeh Medical Center
🇮🇱Zerifin, Israel
IJsselland Ziekenhuis Poli Interne geneeskunde
🇳🇱Capelle A/d IJssel, Netherlands
CHU Côte de Nacre
🇫🇷Caen, France
Canadian Centre for Research on Diabetes
🇨🇦Smiths' Falls, Ontario, Canada
CHU Toulouse Rangueil
🇫🇷Toulouse, France
Dr.Garcjan Podgorski
🇿🇦Port Elizabeth, South Africa
Maxima Medisch Centrum
🇳🇱Eindhoven, Netherlands
Bethesda Diabetes Research Center
🇳🇱Hoogeveen, Netherlands
Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic
🇭🇺Budapest, Hungary
ICMDM Hospital Clínic i Universitari
🇪🇸Barcelona, Spain
Universita di Perugia - Ospedale S.M. Della Misericordia
🇮🇹Perugia, Italy
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Endocrinologist, 202-301 Columbia Street East
🇨🇦New Westminster, British Columbia, Canada
Zentrum für Diabetes und Gefäßerkrankungen
🇩🇪Münster, Germany
CHU de Nancy
🇫🇷Nancy, France
Chaim Sheba Medical center Endocrinology unit
🇮🇱Tel Hashomer - Ramat Gan, Israel
University Clinic of Endocrinology
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of