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.
MiniMed® 640G User Evaluation
Choudhary. ADA Poster Presentation June 2015.
Predictive Low Glucose Managment
40 subjects with Type 1 diabetes were enrolled at 3 European centers and provided with MiniMed® 640G systems for 4 weeks.
- Average of 2.1 pump suspends per day
- In 83.1% of the suspend before low events where the pump stopped delivering insulin, the SG value never reached the pre-set low limit
- The overall mean (±SD) duration of an automatic pump suspension event was 56.3±9.5 min
- The mean SG nadir following pump suspensions was 70.3±7.1 mg/dL
The PILGRIM Study: In Silico Modeling of a Predictive Low Glucose Management System and Feasibility in Youth with Type 1 Diabetes During Exercise
Danne et al. Diabetes Technol Ther. 2014 Jun;16(6):338-47.
Predictive Low Glucose Management
Proof of concept study with two phases, in-silico modelling and clincal study with 22 patients with Type 1 to determine the effectiveness and safety of Predictive Low Glucose Management.
- 80% of hypoglycaemic events were avoided by use of SmartGuard® (defined as SG <3.9 mmol/L)
- SmartGuard® achieved 42% less time spent low compared to Low Glucose Suspend
- The sensor glucose value for suspension (92 ±7 mg/dL) and resumption (97±19mg/dL) were similar, however the values were falling at suspension and rising at resumption
Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial
Ly TT et al. JAMA. 2013 Sep 25;310(12):1240-7.
Benefits of Low Glucose Suspend
RCT comparing the rates of severe hypoglycaemia (coma/seizure) in patients using CSII versus Sensor Augmented Pump therapy with the Low Glucose Suspend feature ON over a 6 month period in 95 children and adults with impaired hypo awareness.
- Significant reduction in the number of severe hypoglycaemic events from 21.9 to 0.0 events/100pt-yrs (low glucose suspend-On group)vs. 24.8 to 26.7 events/100 pt-yrs in the CSII group (p=0.017)
- Significant reduction in exposure to glucose values below 70mg/dl and 60mg/dl in the low glucose suspend group compared to control (p=0.006 and p=0.009 respectively)
- Reduced fear of hypoglycaemia was shown in the low glucose suspend group
ASPIRE In-Home: Rationale, Design, and Methods of a Study to Evaluate the Safety and Efficacy of Automatic Insulin Suspension for Nocturnal Hypoglycemia
Klonoff DC et al. J Diabetes Sci Technol 2013;7(4):1005–1010
Benefits of Low Glucose Suspend
RCT comparing the sensor augmented pump therapy with low glucose suspend feature ON, vs. sensor augmented pump therapy alone, over a 3 months in 247 adults & teens in 19 US centres.
Low glucose suspend ON significantly reduced:
- The proportion of values in the hypoglycaemic range (<70mg/dl)
- The nocturnal hypo area under the curve (AUC) by 37.5%
- Daytime and night-time hypoglycemic AUC by 31.4%
Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study
Bergenstal RM et al. Diabetes Care. 2011 Nov;34(11):2403-5.
Benefits of Sensor Augmented Pump Therapy
Six month single-crossover continuation phase of STAR 3 with 420 patients to determine the effects of crossing over from optimised multiple daily injections to Sensor-Augmented Pump therapy for six months and determine the effects of 10 months use of sensor augmented pump therapy.
Those multiple daily injections subjects who switched to sensor augmented pump therapy at 12 months achieved 0.5% A1C reduction – used sensors 60% of time to achieve this.
- Those sensor augmented pump therapy subjects were able to maintain their A1C levels with 40% sensor wear
- Switching from optimized multiple daily injections to sensor augmented pump therapy allowed for rapid and safe A1C reductions. Glycaemic benefits of sensor augmented pump therapy persist for at least 18 months
Sensor Augmented Pump therapy, Pump therapy vs multiple daily injections, Pump therapy, Continuous Glucose Monitoring
