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.
“Let the Algorithm Do the Work” -Reduction of Hypoglycemia Using Sensor-Augmented Pump Therapy with Predictive Insulin Suspension (SmartGuard) in Pediatric Type 1 Diabetes Patients
Biester, T , A et al. DIABETES TECHNOLOGY & THERAPEUTICS. Vol 19. Number 3, 2017
Insulin Pump Therapy with automated predictive insulin suspension
Prospective, multicentre user evaluation assessing 6 weeks of SAP with Suspend Before Low vs 2 weeks of Sensor Augmented Pump Therapy Alone (no Suspend) in 24 paediatric patients.
Suspend Before Low:
- Reduced the number of instances in which the glucose level was < 3.9mmol without a significant change in mean glucose concentration or HbA1c.
- The study also looked at how patient behaviour (manual overrides and carbohydrate intake) affected glucose profiles following suspensions
- The study sets out some recommendations for educating patients on how to respond to the Suspend Before Low events
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
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
Pregnancy outcome and glycemic control in women with Type 1 diabetes: A retrospective comparison between CSII and multiple daily injections treatment
Talaviya et al. Diabetes Metab Syndr. 2013 Apr-Jun;7(2):68-71.
Pumps in Pregnancy
Retrospective observational study of 34 pregnant Type 1 patients (pump therapy n=14 / multiple daily injections n=20) to evaluate glycaemic control and maternal-fetal outcome.
- Reduction in A1C was greater in all 3 trimesters when CSII was used
- Duration of pregnancy and birth weights were the same in both groups
- Rate of abortion, preterm labour, caesarean section and newborn hypoglycaemia were all better in CSII treated pregnancies
- Daily insulin requirements were less in CSII
The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus (DCCT)
Nathan et al. N Engl J Med 1993; 329:977-986.
Benefits of Treating to Target
1,441 patients randomised control trial comparing complications of conventional therapy vs intensive management via pump or multiple daily injections.
Intensive cohort reduced adjucted mean risk for developing the following:
- Retinopathy by 76%
- Nephropathy by 56%
- Neuropathy by 60%
