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.
MiniMed® 670G Real World Data
PARAMETERS ASSESSED:
Mean sensor glucose (SG) level
Time spent in the target range (TIR) – 3.9-10mmol/L
Time spent in hypoglycaemia - < 3.9mmol/L
Time spent in hyperglycaemia - > 10mmol/L
SmartGuard® Auto Mode Technology - Hybrid Closed Loop System
Retrospective Analysis of Carelink™ database (patient self-uploaded electronic data base) 3,141 subjects with Diabetes Mellitus who completed 3 months of SmartGuard® Auto Mode.
Comparison were made between Manual Mode and SmartGuardTM Auto Mode data
From Manual Mode usage to SmartGuard® Auto Mode usage:
The time spent in the target range(TIR) increased from 66.0% to 73.3%.
The time spent in hypoglycaemia <3.9 mmol/L decreased from 2.7% to 2.1%.
The time spent in hyperglycaemia >10.0 mmol/L decreased from 31.4% to 24.6%
Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes.
Garg et al. DIABETES TECHNOLOGY & THERAPEUTICS. Volume 19, Number 3 2017
Hybrid Closed Loop Insulin Delivery System (SmartGuard Auto Mode)
A Prospective before and after Multi-centre study assessing SmartGuard® Auto Mode vs Manual Mode (SAP) in adolescents(n= 30)and adults(n=94) with Type 1 Diabetes over 3 months.
The Pivotal study has showed that MiniMed® ™ 670G can be used by adolescents and adults with Type 1 diabetes in an outpatient setting with no episodes of severe hypoglycaemia and DKA in over 12,000 patient days of use.
The SmartGuard® Auto Mode feature was associated with significant HbA1c reduction, from baseline, 7.8% to 7.2% in adolescents and 7.4% to 6.9% in adults.
Additionally the SmartGuard® Auto Mode feature was associated with an increased time spent in glycaemic target range (3.9-10.0mmol/L), reducing both hypoglycaemia and hyperglycaemia, in both adolescents and adults.
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.
“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
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
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 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
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
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.
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
