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.
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.
