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.
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“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
Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial
Ly TT et al. JAMA. 2013 Sep 25;310(12):1240-7.
Benefits of Low Glucose Suspend
RCT comparing the rates of severe hypoglycaemia (coma/seizure) in patients using CSII versus Sensor Augmented Pump therapy with the Low Glucose Suspend feature ON over a 6 month period in 95 children and adults with impaired hypo awareness.
- Significant reduction in the number of severe hypoglycaemic events from 21.9 to 0.0 events/100pt-yrs (low glucose suspend-On group)vs. 24.8 to 26.7 events/100 pt-yrs in the CSII group (p=0.017)
- Significant reduction in exposure to glucose values below 70mg/dl and 60mg/dl in the low glucose suspend group compared to control (p=0.006 and p=0.009 respectively)
- Reduced fear of hypoglycaemia was shown in the low glucose suspend group
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
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%
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).
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%
Effect of Carelink, an internet-based insulin pump monitoring system, on glycemic control in rural and urban children with Type 1 diabetes mellitus
Corriveau et al. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):360-6.
CareLink®
Review of 94 paediatrics treating with insulin pump therapy comparing glycaemic control, diabetes self-care measures, frequency of clinic visits, and geographic location associated with CareLink® use to determine whether use of the internet-based insulin pump monitoring system, Carelink, improved glycemic control in rural and urban children treated with insulin pump therapy.
- Patients using CareLink showed a statistically significant improvement in A1C levels as compared to patients not using CareLink.
- Rural CareLink users showed improvement in A1C levels following CareLink use, yet had significantly fewer clinic visits per year compared with urban patients.
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.
Use of telemedicine in subjects with Type 1 diabetes equipped with an insulin pump and real-time continuous glucose monitoring
González-Molero I et al. J Telemed Telecare. 2012 Sep;18(6):328-32.
CareLink® Personal
The study was conducted on 15 patients with type 1 diabetes, all treated for more than 1 year with insulin pump therapy and an integrated real-time continuous glucose monitoring system (Paradigm real time PRT, Northridge, CA, USA), with HbA1c , 8% and normal renal function. The subjects were followed up for 1 year and monitored exclusively by telemetry (CareLink®) during the last 6 months of this period. During the first 6 months, the subjects were provided with the telemetry material and given instructions about its use. The participants made 3 outpatient visits: at the start of the study, i.e. 6 months before beginning the telemetry period (pre-baseline), just before starting the telemetry period (baseline), and 6 months after initiating the telemetry period (6-month visit).
A1C baseline 7.5%; A1C at baseline 7.24% and A1C at 6 months 6.97% (p=0.011). "Thus, we conclude that adults T1DM on sensor augmented pump therapy and who have acceptable metabolic control and optimized treatment can benefit from the addition of a telemetry system to their usual outpatient follow-up, experiencing additional improvements in their HbA1c, glucose variability and quality of life, as well as a reduction in their fear of hypoglycaemia."
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
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
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
The SWITCH study (sensing with insulin pump therapy to control HbA1c): design and methods of a randomized controlled crossover trial on sensor-augmented insulin pump efficacy in type 1 diabetes suboptimally controlled with pump therapy
Battelino T et al. Diabetes Technol Ther. 2011 Jan;13(1):49-54.
Benefits of Sensor Augmented Pump Therapy
Sensor augmented pump therapy vs CSII in adults and children (7.5%<HbA1c<9.5%). RCT, 17 months f/up, 153 pts.
A1c decreased in both age groups:
- Children: - 0.46% (p< 0.001; n = 72)
- Adults: - 0.41% (p< 0.001; n = 81)
Children using continuous glucose monitoring missed significantly less school days (51.9 vs. 183 days/100 pt years). Subjects performed significantly fewer SMBG during the Sensor On period (daily median 4.9 vs. 5.5).
Reduction in Hypoglycemia With the Predictive Low-Glucose Management System: A Long-term Randomized Controlled Trial in Adolescents With Type 1 Diabetes.
Abraham, M , et al. DIABETES CARE. 2018, Feb; 41 (2): 303-310
Insulin Pump Therapy with automated predictive insulin suspension
Multi-centre, unblinded randomised controlled phase 3 home trial over six months. 154 participants with type 1 diabetes aged 8-20 years on MiniMed 640G were randomised to have the automatic suspend before low function on or off for the duration of six months.
- Children and adolescents spent approximately half the time in hypoglycaemia with fewer hypoglycaemic events with Suspend Before Low ON as compared with Suspend Before Low OFF.
- The lower hypoglycaemia exposure was consistent in subgroups of participants irrespective of age, duration of diabetes, HbA1c and hypoglycaemia awareness status.
- The reduction in hypoglycaemia was not associated with a deterioration of glucose control as measured by hyperglycaemia or HbA1c, nor in a reduction in quality of life.
ASPIRE In-Home: Rationale, Design, and Methods of a Study to Evaluate the Safety and Efficacy of Automatic Insulin Suspension for Nocturnal Hypoglycemia
Klonoff DC et al. J Diabetes Sci Technol 2013;7(4):1005–1010
Benefits of Low Glucose Suspend
RCT comparing the sensor augmented pump therapy with low glucose suspend feature ON, vs. sensor augmented pump therapy alone, over a 3 months in 247 adults & teens in 19 US centres.
Low glucose suspend ON significantly reduced:
- The proportion of values in the hypoglycaemic range (<70mg/dl)
- The nocturnal hypo area under the curve (AUC) by 37.5%
- Daytime and night-time hypoglycemic AUC by 31.4%
The PILGRIM Study: In Silico Modeling of a Predictive Low Glucose Management System and Feasibility in Youth with Type 1 Diabetes During Exercise
Danne et al. Diabetes Technol Ther. 2014 Jun;16(6):338-47.
Predictive Low Glucose Management
Proof of concept study with two phases, in-silico modelling and clincal study with 22 patients with Type 1 to determine the effectiveness and safety of Predictive Low Glucose Management.
- 80% of hypoglycaemic events were avoided by use of SmartGuard (defined as SG <3.9 mmol/L)
- SmartGuard achieved 42% less time spent low compared to Low Glucose Suspend
- The sensor glucose value for suspension (92 ±7 mg/dL) and resumption (97±19mg/dL) were similar, however the values were falling at suspension and rising at resumption
