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.
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
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).
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<sup>™</sup> 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."
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<sup>™</sup>
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.
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).
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
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
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
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
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%
