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
Insulin pump treatment compared with multiple daily injections for treatment of Type 2 diabetes (OpT2mise): a randomised open-label controlled trial
Reznik et al. The Lancet. 2014. DOI 10.1016/S0140-6736(14)61037-02.
T2 Pump Therapy vs Multiple Daily Injections
Multicentre, randomised controlled trial of people (331 participants) with Type 2 diabetes not currently meeting glycated haemoglobin targets comparing the efficacy of pump treatment and multiple daily injections for lowering glucose.
At 6 months, mean glycated haemoglobin had decreased by 1·1% in the pump treatment group and 0·4% in the multiple daily injection group, resulting in a between-group treatment difference of –0·7%. At the end of the study, the mean total daily insulin dose was 97 units with pump treatment versus 122 units for multiple daily injections, with no significant difference in bodyweight change between the two groups.
Hypoglycemia Prevention and User Acceptance of an Insulin Pump System with Predictive Low Glucose Management
Choudhary,P., et al., Diabetes Technology and Therapeutics, 2016; 18 (5): 288-291
Insulin Pump Therapy with automated predictive insulin suspension
The aim was to estimate the 640G system’s ability to prevent predicted hypoglycemia and its acceptability to users. The design was a three-centre, international, single-arm study, duration four weeks (n = 40), with retrospective analysis of pump and sensor upload data and participant questionnaires.
Automatic insulin pump suspension with the 640G system can help patients avoid hypoglycemia, without significantly increasing hyperglycemia and is well accepted.
- There were 2,322 suspend before low events (2.1 per patient-day) with 83.1% of those suspensions not reaching individualized preset low limits 50 -80 mg/dL (2.8–4.5mmol/L)
- The mean absolute relative difference between paired BG and SG values was 10.9%
- Participants reported they were confident using the system and agreed that it helped protect them from hypoglycaemia
Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes (STAR3)
Bergenstal RM et al. N Engl J Med 2010; 363:311-320.
Benefits of Sensor Augmented Pump Therapy
1 year, multicentre, randomised control trial with 485 patients to determine the effectiveness of insulin pump therapy compared to multiple daily injections.
In the sensor augmented pump therapy group, A1C values fell rapidly from baseline to 3 months and remained lower than levels in the multiple daily injections group for the rest of the study in both the adult and paediatric groups.
- Mean change in A1c was -0.6% for sensor augmented pump therapy vs. multiple daily injections
- Mean change in A1c was -0.6% for sensor augmented pump therapy vs. multiple daily injections in adults
- Mean change in A1c was -0.5% for sensor augmented pump therapy vs. multiple daily injections in paediatrics
- All subjects – 27% reached A1C targets vs. 10% on multiple daily injections. 44% vs. 20% in paediatrics
- An increased frequency of sensor use was associated with a greater reduction in A1C values from baseline to 1 year (p=0.003)
Prevention of Insulin-Induced Hypoglycemia in Type 1 Diabetes with Predictive Low Glucose Management System
Abraham, M.A., et al., Diabetes Technology and Therapeutics, 2016; 18 (7): 1-8
Insulin Pump Therapy with automated predictive insulin suspension
The aim was to determine the effectiveness of Pedictive Low Glucsoe Management (PLGM) in preventing insulin induced hypoglycemia in two controlled in-clinic conditions, 1. excess insulin bolus during the day and 2. increased basal insulin delivery overnight. The design for the insulin bolus protocol was a three-centre, randomized, controlled, crossover trial (n = 28). The design for the increased basal protocol was similar but a single centre (n = 8) with 180% night-time basal rates. For both conditions the PLGM algorithm was set to suspend insulin at sensor glucose predicted to be <80 mg/dL (4.4 mmol/L) within 30 mins, and the control condition was SAPT alone with no insulin suspension. The primary outcome was need for hypoglycaemia treatment, either due to symptoms or plasma glucose <50 mg/dL (2.8 mmol/L).
SAPT with PLGM substantially reduced the requirement for hypoglycemia treatment following insulin induced hypoglycemia in an in-clinic setting
- With excess insulin bolus, 24/28 participants required hypoglycemia treatment with SAPT alone compared to 5/28 with PLGM (P < 0.001)
- With increased basal all 8/8 SAPT alone participants required treatment for hypoglycemia compared to only one using PLGM
- There were no instances of hyperglycemia following any 2hr pump suspensions with PLGM
