OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy (OpT2mise)
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|ClinicalTrials.gov Identifier: NCT01182493|
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : March 15, 2016
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||331 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Insulin Pump Treatment
Patients will get an insulin pump
Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)
The pump delivers insulin as specified by the patient
Other Name: Medtronic MiniMed Paradigm® VEO system (MMT-554/754
No Intervention: Insulin treatment with MDI
patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
- Between Group Difference in HbA1c When Comparing CSII to MDI [ Time Frame: 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
- Change in Glycemic Variability - AUC in Hypo (≤70mg/dL) [ Time Frame: 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 [ Time Frame: 6 months ]Severe hypoglycemia incidence during the study
- Change in Glycemic Variability - AUC in Hyper (≥180mg/dL) [ Time Frame: 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
- Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: 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
- Change in Body Weight [ Time Frame: 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
- Safety - Diabetic Ketoacidosis Incidence [ Time Frame: 6 Months ]Diabetic Ketoacidosis incidence during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182493
|Principal Investigator:||Ohad Cohen, MD||Chaim Sheba Medical Center, Tel Hashomer, Israel|
|Principal Investigator:||Ignacio Conget, MD||ICMDM Hospital Clínic i, Barcelona, Spain|
|Principal Investigator:||Yves Reznic, MD||CHU Côte de Nacre, France|
|Principal Investigator:||Ronnie Aronson, MD||FRCPC, FACE LMC Endocrinology Centres, Canada|