OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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
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
Safety - Diabetic Ketoacidosis Incidence	6 Months	Diabetic Ketoacidosis incidence during the study

Trial Locations

Locations (36): Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
Albany Medical College
🇺🇸
Albany, New York, United States
SUNY Upstate Medical University
🇺🇸
Syracuse, New York, United States
City hopital Vienna-Hieting
🇦🇹
Vienna, Austria
Clinical Professor Department of Medicine University of Calgary
🇨🇦
Calgary, Alberta, Canada
Endocrinologist, 202-301 Columbia Street East
🇨🇦
New Westminster, British Columbia, Canada
416-1033 Davie St
🇨🇦
Vancouver, British Columbia, Canada
Health Science Centre
🇨🇦
St. John's, Newfoundland and Labrador, Canada
LMC Endocrinology Centre
🇨🇦
Oakville, Ontario, Canada
Canadian Centre for Research on Diabetes
🇨🇦
Smiths' Falls, Ontario, Canada
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Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States