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.
Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study
Bergenstal RM et al. Diabetes Care. 2011 Nov;34(11):2403-5.
Benefits of Sensor Augmented Pump Therapy
Six month single-crossover continuation phase of STAR 3 with 420 patients to determine the effects of crossing over from optimised multiple daily injections to Sensor-Augmented Pump therapy for six months and determine the effects of 10 months use of sensor augmented pump therapy.
Those multiple daily injections subjects who switched to sensor augmented pump therapy at 12 months achieved 0.5% A1C reduction – used sensors 60% of time to achieve this.
- Those sensor augmented pump therapy subjects were able to maintain their A1C levels with 40% sensor wear
- Switching from optimized multiple daily injections to sensor augmented pump therapy allowed for rapid and safe A1C reductions. Glycaemic benefits of sensor augmented pump therapy persist for at least 18 months
Sensor Augmented Pump therapy, Pump therapy vs multiple daily injections, Pump therapy, Continuous Glucose Monitoring
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)
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.
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
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
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.
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
Association of glycaemia with macrovascular and microvascular complications of Type 2 diabetes (UKPDS 35): prospective observational study
Stratton et al. BMJ 2000; 321:405.
Benefits of Treating to Target - Type 2
A prospective observational study of 3,642 patients to determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with Type 2 diabetes.
The incidence of clinical complications was significantly associated with glycaemia. Each 1% reduction in updated mean HbA1c was associated with reductions in risk of 21% for any end point related to diabetes, 21% for deaths related to diabetes, 14% for myocardial infarction, and 37% for microvascular complications.
Intensive Diabetes Treatment and Cardiovascular Disease in Patients with Type 1 Diabetes
Nathan et al. N Engl J Med 2005; 353:2643-2653.
Benefits of Treating to Target
An observational follow up of DCCT study (1,394 patients randomised control trial assigned to either current conventional therapy or intensive management via pump or multiple daily injections) to compare cardiovascular complications.
Intensive cohort reduced adjusted mean risk for developing the following:
- Cardiovascular disease by 42%
- Heart attack and stroke 57%
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%
