Medtronic plc Announces Children achieve Time in Range mirroring well-controlled adults for the first time in real-world study of the MiniMed 780G system
October 20, 2021 at 01:51 am IST
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Medtronic plc announced one-year, real-world clinical data on 3,211 pediatric and adolescent patients with type 1 diabetes 15 years old and below using the MiniMed 780G system1 with the Guardian Sensor 3. Data on this subset of patients on the system in Europe showed an average Time in Range of 74% ? surpassing Clinical Consensus Guidelines and closely mirroring Time in Range for adults at 77%. Overnight Time in Range of 82% also mirrored that of adults (82%) demonstrating that the Advanced Hybrid Closed Loop (AHCL) algorithm offers even stronger glycemic control and protection against lows while children are sleeping. The MiniMed 780G system delivers near real-time basal insulin and auto correction boluses (every 5 minutes) to address underestimated carb counts and occasional missed meal doses to deliver more Time in Range. From an experience perspective, younger users remained in Advanced Hybrid Closed Loop (AHCL) mode, also referred to as the SmartGuard? algorithm, for an average of 93% of the time, similar to the 92% observed in users over 15 years old. When the pediatric group set a blood glucose target of 110mg/dL (6.1 mmol/L) and an Active Insulin Time (AIT) of two hours, they achieved an average Time in Range of 77% and a Glucose Management Indicator (GMI) of 6.7%. With these settings, they only spent 2.7% of their time <70 mg/dL (5.9 mmol/L). The real-world performance analysis aggregates information from children 15 years old and below whose caregivers agreed to allow Medtronic to use anonymized data that was automatically uploaded their data to CareLink? Personal from August 27, 2020 to July 22, 2021. A large majority of pediatric users included in the analysis are achieving glycemic goals recommended by major diabetes professional organizations, including: 75.3% of pediatric users had a Glucose Management Indicator (GMI) less than 7%, which mirrors the average A1C level that would be expected based on mean glucose. 69.6% of pediatric users had a Time in Range above 70%. 67.5% of pediatric users achieved both, a GMI less than 7% and a Time in Range above 70%.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
Medtronic plc Announces Children achieve Time in Range mirroring well-controlled adults for the first time in real-world study of the MiniMed 780G system