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
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
Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial
Murphy et al. BMJ 2008;337:a1680.
Continuous Glucose Monitoring in Pregnancy
Prospective, open label randomised controlled trial of 71 women with Type 1 diabetes (n=46) or type 2 diabetes (n=25) allocated to antenatal care plus continuous glucose monitoring (n=38) or standard antenatal care (n=33) to evaluate the effectiveness of continuous glucose monitoring on maternal glycaemic control, infant birth weight, and risk of macrosomia.
Women randomised to continuous glucose monitoring had lower mean HbA1c levels from 32 to 36 weeks’ gestation compared with women randomised to standard antenatal care: 5.8% (SD 0.6) v 6.4% (SD 0.7). Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight standard deviation scores (0.9 v 1.6; effect size 0.7 SD, 95% confidence interval 0.0 to 1.3), decreased median customised birthweight centiles (69% v 93%), and a reduced risk of macrosomia (odds ratio 0.36, 95% confidence interval 0.13 to 0.98).
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%
