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EVIDENCE

CLINICAL STUDIES LIBRARY

We have compiled a variety of clinical studies that you can receive upon request. These studies provide key evidence regarding the efficacy of therapies, pumps, CGM and more.
Use the filters to quickly find the information you need.

2016 - MINIMED 640G WITH SMARTGUARD TECHNOLOGY - REAL LIFE DATA

REFERENCE

Zhong A. et al, Effectiveness of Automated Insulin Management Features of the Medtronic 640G Sensor-Augmented Insulin Pump.Diabetes Technol Ther. 2016;18(10): 657-663.

KEYPOINTS

  • 75% of SmartGuard predicted hypoglycaemic events did not reach the pre-set low limit
  • Less glycemic variability and faster hypoglycaemia recovery when user does not intervene with suspension
  • MiniMed 640G users were utilizing Automatic Insulin delivery suspension (and sensor use) for 94% of days, aprox 20% more than on MiniMed Veo and 530G

View Summary

2015 - MINIMED 640G USER EVALUATION

REFERENCE

Prevention of hypoglycemia by the predictive low glucose management feature in a user evaluation study. Conget I. et al. EASD Diabetologia Abstracts 58 (1):416, 2015.

KEYPOINTS

  • Following 83% of the PLGM suspension events the pre-set low glucose limit was avoided
  • No significant increase in hyperglycaemia
  • Subjects assessed MiniMed® 640G was easy to use and helped facilitate their diabetes management

VIEW SUMMARY

2015 - OPT2MISE 12 MONTHS - INSULIN PUMP THERAPY VS MULTIPLE DAILY INJECTIONS IN TYPE 2 DIABETES

REFERENCE

Sustained efficacy of insulin pump therapy, compared with multiple daily injections, in type 2 diabetes: 12-month data from the OpT2mise randomized trial. Ronnie Aronson, Yves Reznik, Ignacio Conget, Javier A Castañeda, Sarah Runzis, Scott W Lee, and Ohad Cohen for the OpT2mise Study Group. DOI: 10.1111/dom.12642

KEYPOINTS

  • Significant clinical benefits demonstrated for poorly controlled T2 subjects on MDI when switched to CSII
  • Sustained clinical benefits were observed over 12 months
  • Reproducible benefits after 2 or 8 months of insulin intensification.

PRIMARY ENDPOINT

  • Between-group difference in mean change in HbA1c from baseline to 6 months.

SECONDARY ENDPOINTS

  • Within-group differences at 12 months in HbA1c
  • AUC in hypo/ Hyperglycaemia Patient treatment satisfaction
  • Safety: Number of severe Hypoglycaemic events and diabetic ketoacidosis events

VIEW SUMMARY

2013 - ASPIRE IN-HOME - BENEFIT OF SAP WITH LGS COMPARED TO STANDARD SAP

REFERENCE

Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia. Bergenstal R.M. et al. N Engl J Med 369:224-32, 2013.

KEYPOINTS

  • 37.5% reduction of nocturnal hypoglycaemia (AUC)
  • 29.8% overall reduction of hypoglycaemic events
  • No increase in HbA1c
  • No severe hypoglycaemic events

ENDPOINTS

  • Nocturnal hypoglycaemia AUC and events
  • Combined nighttime and daytime hypoglycaemia AUC and events
  • HbA1c levels

VIEW SUMMARY

2012 - SWITCH - BENEFITS OF SAP VS CSII

REFERENCE

The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Battelino T. et al. Diabetologia 55:3155-3162, 2012.

KEYPOINTS

  • 0.43% lower HbA1c with SAP
  • Larger HbA1c difference when sensor is used >70% of the time (-0.51%)
  • 38.7% reduction in hypoglycaemia
  • 18.9% reduction in hyperglycaemia
  • 15.7% increase in euglycaemia
  • Removal of CGM resulted in a loss of metabolic benefit

ENDPOINTS

  • Difference in HbA1c levels between Sensor On and Sensor Off after 6 months of follow-up, adjusting for baseline levels
  • Time spent in hypoglycaemia (<3.9 mmol/L)
  • Time spent hyperglycaemia (>10 mmol/L)
  • Time spent in euglycaemia (3.9-10 mmol/L).

VIEW SUMMARY

2011 - CGM META ANALYSIS - BENEFIT OF CGM VS SMBG

REFERENCE

Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta- analysis of randomized controlled trials using individual patient data. Pickup JC et al. BMJ 2011;343:d3805. doi: 10.1136/bmj.d3805.

KEYPOINTS

  • 0.3% reduction in HbA1c
  • Larger HbA1c reduction with increased CGM usage
  • 0.23% reduction in hypoglycaemia exposure

ENDPOINTS

  • Change in HbA1c levels Change in hypoglycaemia AUC

VIEW SUMMARY

2010 - STAR3 - BENEFIT OF SAP THERAPY VS MDI

REFERENCE

Effectiveness of Sensor-Augmented Insulin Pump Therapy in Type 1 Diabetes. Bergenstal RM, et al. N Engl J Med 363:311-20, 2010.

KEYPOINTS

  • 0.6% HbA1c reduction between- group
  • Increased CGM usage results in greater HbA1c reduction
  • Reduction in hyperglycaemia No increase in hypoglycaemia

ENDPOINTS

  • Change in HbA1c level
  • Rate of severe hypoglycaemia AUC in hypoglycaemia
  • AUC in hyperglycaemia

VIEW SUMMARY

2009 - CGM WELL CONTROLLED - BENEFIT OF CGM IN WELL CONTROLLED TYPE 1 DIABETES

REFERENCE

The Effect of Continuous Glucose Monitoring in Well-Controlled Type 1 Diabetes. Juvenile Diabetes Research Foundation (JDRF) Continuous Glucose Monitoring Study Group. Diabetes Care 2009;32:1378–1383

KEYPOINTS

  • 7.8 times bigger reduction in time spent in hypoglycaemia (<70 mg/dL) in the CGM group
  • 46.8% less hypoglycaemic events (<54 mg(dL) in the CGM group
  • No increase of HbA1c

ENDPOINTS

  • Time spent in hypoglycaemia <70 mg/dL
  • Severe hypoglycaemia HbA1c levels

VIEW SUMMARY

CARELINK DATA MINING - REAL LIFE USE OF CGM

REFERENCE

Routine use of continuous glucose monitoring in 10 501 people with diabetes mellitus. Battelino et al. Diabetic Med., published online July 14, 2015. doi:10.1111/dme.12825.

KEYPOINTS

  • Increased usage of CGM is associated with:
  • ✓ Greater chance of achieving HbA1c <7%
  • ✓ Greater reduction of hypoglycaemia
  • Usage of CGM during the first month is strongly associated with long-term adherence

VIEW SUMMARY

CSII LONG TERM - LONG TERM BENEFIT OF CSII IN CHILDREN COMPARED TO INJECTION THERAPY

REFERENCE

Long-term outcome of insulin pump therapy in children with type 1 diabetes assessed in a large population-based case-control study. Johnson SR, Cooper MN, Jones TW, Davis EA. Diabetologia 56:2392-2400, 2013.

KEYPOINTS

  • 0.6% reduction in HbA1c compared to injection therapy
  • 51% reduction in the rate of severe hypoglycaemia
  • No increase in hospitalization for DKA

ENDPOINTS

  • HbA1c levels
  • Rate of severe hypoglycaemia DKA hospitalisation

VIEW STUDY

CSII META ANALYSIS - BENEFIT OF CGM VS SMBG

REFERENCE

Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Pickup J.C., Sutton A.J. Diabetes Medicine 25(7):765-774, 2008.

KEYPOINTS

  • 4.19 times less severe hypoglycaemia with CSII
  • 0.62% lower HbA1c levels with CSII

ENDPOINTS

  • Rates of severe hypoglycaemic events
  • Difference in HbA1c levels

VIEW SUMMARY

LGS SEVERE HYPO - THE IMPACT OF SAP THERAPY WITH LGS IN HYPOGLYCAEMIA REDUCTION

REFERENCE

Effect of Sensor-Augmented Insulin Pump Therapy and Automated Insulin Suspension vs Standard Insulin Pump Therapy on Hypoglycaemia in Patients With Type 1 Diabetes. A Randomized Clinical Trial. Ly T.T. et al. JAMA 310(12):1240-1247, 2013.

KEYPOINTS

  • No severe hypoglycaemic events with SAP therapy and LGS technology
  • Incidence rate of Hypoglycaemia is 3.6 lower with SAP therapy and LGS technology
  • No increase in HbA1c

ENDPOINTS

  • Combined incidence of severe and moderate hypoglycaemia
  • HbA1c levels

VIEW SUMMARY

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