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
Characteristics of basal insulin requirements by age and gender in Type 1 diabetes patients using insulin pump therapy
Scheiner and Boyer. Diabetes Res Clin Pract. 2005 Jul;69(1):14-21.
Pump Therapy vs. Multiple Daily Injections
Observational study of 322 patients to determine whether basal insulin requirements vary by age group and time of day in patients with Type 1 diabetes.
- Results indicate basal needs are unlikely to be met by one flat rate of basal delivery
- Type 1 patients on average require 5.2 rates per 24 hours.
- 2 distinct patterns – adult and juvenile
- No 2 patients had the same profile
Sustained efficacy of insulin pump therapy compared with multiple daily injections in type 2 diabetes: 12-month data from the OpT2mise randomized trial
Aronson, R et al. Diabetes, Obesity and Metabolism 2016
Insulin Pump use in patients with Type 2 Diabetes
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. 12 Month cross over follow up.
Cohort initially randomised to pump therapy:
- Experienced a further 0.1% reduction in A1C to attain a final 12-month value of 7.8%
- Maintained the reduction in insulin requirement
Cohort crossed over from MDI to pump therapy at six months:
- Experienced similar results seen in the original insulin pump group
- Doubled their A1C reduction from 0.4% to 0.8%
- Used 19% less insulin
Consequences of delayed pump infusion line change in patients with Type 1 diabetes mellitus treated with continuous subcutaneous insulin infusion
Thethi et al. J Diabetes Complications. 2010 Mar-Apr;24(2):73-8.
Changing Lines Regularly
A randomised crossover trial with 20 patients with Type 1 diabetes to investigate the lack of adherence to the recommended change in insulin pump infusion line use beyond 48h.
From Day 2 to Day 5 of the pump line use, the daily average glucose level increased from 122.7 to 163.9 mg/dl, fasting glucose from 120.3 to 154.5 mg/dl, postprandial glucose from 114.6 to 172.1 mg/dl, and the daily maximum glucose from 207.7 to 242.8 dl. Time period that the glucose was N180 mg/dl increased from 14.5% to 38.3% (Pb.05). Loss of control occurred despite increase in total daily insulin dose from 48.5±11.8 to 55.3±17.9 U.
Adaptability of structured forms for CSII initiation in patients with type 2 diabetes the Getting2Goal concept
Cohen, O et al. Italian Society of Endocrinology (SIE:) 2016
Insulin Pump use in patients with Type 2 Diabetes
Small qualitative observational study
Surveys completed by physicians indicated Getting2Goal type 2 pumping protocol to be more efficient, time saving, and structured compared to their current processes. In addition, the primarily prescribed total daily dose (TDD) on pump was 98.1 ± 50.0 units and the TDD at first download was 81.4 ± 36.4 units, representing a 25.4 % reduction in TDD At first download.
Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18,168 people with Type 1 diabetes: observational study
Steineck, I et al. BMJ 2015;350:h3234.
Pump Therapy vs. Multiple Daily Injections
A observational study of 18,168 people with Type 1 diabetes investigating the long term effects of insulin pump therapy on cardiovascular diseaes and mortality.
At follow-up was for a mean of 6.8 years compared to MDI, the adjusted hazard ratios for insulin pump treatment were significantly lower:
- 0.55 for fatal coronary heart disease
- 0.58 for fatal cardiovascular disease (coronary heart disease or stroke)
- 0.73 for all cause mortality
Impact of insulin pump on quality of life of diabetic patients
Ghazanfar, H., et al., Indian Journal of Endocrinology and Metabolism, 2016; 20 (4): 506-511
Benefits Insulin Pump vs pens for T2Case- control study of Quality of Life (QOL) for T2 patients using insulin pump therapy (n=83) vs. controls on pen insulin (n=322) from a single centre. The objective was to compare QOL between the pump and pen groups
Case- control study of Quality of Life (QOL) for T2 patients using insulin pump therapy (n=83) vs. controls on pen insulin (n=322) from a single centre. The objective was to compare QOL between the pump and pen groups using the Short form‑36 QOL questionnaire.
People with T2 using pump therapy compared to pens reported significant benefits:
- Higher self-esteem, less stress, and better mood
- Better physical health, meal time flexibility, and ease of travel
- Improved personal and family life
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
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
