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 Therapy for Type 1 Diabetes Mellitus
Pickup and Phil. N Engl J Med 2012; 366:1616-1624.
Pump Therapy vs. Multiple Daily Injections
Review Article
- Baseline HbA1C is an important determinant on A1C reduction with bigger decreases seen in patients with a higher starting baseline
- Average HbA1c improvement on pump therapy v multiple daily injections: 0.3-0.6%
- Hypo Unawareness Incidence which affects approximately 25% of type 1 patients can lead to a 6X risk of severe hypoglycaemia
- Rate of hypo is over 4 times higher on multiple daily injections than with pump therapy
- Overview of how pumps work, how to best initiate pumps etc.
- A statement that while follow up is quite intense for the first 6 months after a pump start; the group workload for the centre often is less for pump patients than multiple daily injections patients
Effectiveness of Automated Insulin Management Features of the MiniMed 640G Senor-Augmented Insulin Pump
Zhong, A., et al., Diabetes Technology and Therapeutics, 2016; 18 (10): 657-663
640 SAP (Title “Effectiveness of Automated Insulin Management Features of the MiniMed 640G Sensor-Augmented Insulin Pump”)
Retrospective database analysis of sensor-augmented insulin pump uploads to CareLink of MiniMed 640G (n = 4818), MiniMed 530G (n = 39,219), and MiniMed Paradigm Veo (n = 43,193). The objective was to evaluate the glycaemic effectiveness of suspend on low SG (LGS), suspend before low (PLGM) and automatic basal resume pump features. Comparisons were made between when features where enabled and when they were not used. Comparisons were also made between Veo and 640G systems for people who had switched from Veo to 640G.
Real-world data showed enabling the automated insulin management features of the MiniMed 640G system significantly improved glycaemic outcomes:
- When PLGM was enabled people had less time with low SG (<3.9 mmol/L) or high SG (>13.3 mmol/L), (P < 0.001 for each)
- People who switched from the Veo system to the MiniMed 640G system had fewer excursions below 3.9mmo/L and fewer above 13.3mmol/L,(P < 0.001 for each)
- Pump suspension events that automatically resumed recovered SG more rapidly and had a more stabilized endpoint than following manual resumption
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
