Dataset Information

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.

ABSTRACT: OBJECTIVE:To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D). METHODS:Participants (N?=?105, ages 7-13 years, mean age 10.8?±?1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT® venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance. RESULTS:Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9?±?17.2?mg/dL (P?

SUBMITTER: Forlenza GP

PROVIDER: S-EPMC6350071 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.

Forlenza Gregory P GP Pinhas-Hamiel Orit O Liljenquist David R DR Shulman Dorothy I DI Bailey Timothy S TS Bode Bruce W BW Wood Michael A MA Buckingham Bruce A BA Kaiserman Kevin B KB Shin John J Huang Suiying S Lee Scott W SW Kaufman Francine R FR

Diabetes technology & therapeutics 20181226 1

<h4>Objective</h4>To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D).<h4>Methods</h4>Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA<sub>1c</sub>), percentage ...[more]

PMID: 30585770

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Project description:Hybrid closed loop (HCL) systems are the combination of a pump for insulin delivery and a glucose sensor for continuous glucose monitoring. These systems are managed by an algorithm, which delivers insulin on the basis of the interstitial glucose levels. The MiniMed™ 670G system was the first HCL system available for clinical purpose. In this paper, we reviewed the literature about metabolic and psychological outcomes in children, adolescents and young adults with type 1 diabetes treated with MiniMed™ 670G. Only 30 papers responded to the inclusion criteria and thus were considered. All the papers show that the system is safe and effective in managing glucose control. Metabolic outcomes are available up to 12 months of follow-up; longer study period are lacking. This HCL system may improve HbA1c up to 7.1% and time in range up to 73%. The time spent in hypoglycaemia is almost neglectable. Better improvement in blood glucose control is observed in patients with higher HbA1c at HCL system start and larger daily use of auto-mode functionality. Conclusion: The Medtronic MiniMed™ 670G is safe and well accepted, without any increase in the burden for patients. Some papers report an improvement in the psychological outcomes, but other papers do not confirm this finding. So far, it significantly improves the management of diabetes mellitus in children, adolescents and young adults. Proper training and support by the diabetes team are mandatory. Studies for a period longer than 1 year would be appreciated to better understand the potentiality of this system. What is Known: • The Medtronic MiniMedTM 670G is a hybrid closed loop system which combines a continuous glucose monitoring sensor with an insulin pump. • It has been the first hybrid closed loop system available for clinical purpose. Adequate training and patients support play a key role in diabetes management. What is New: • The Medtronic MiniMedTM 670G may improve HbA1c and CGM metrics up to 1-year of follow-up, but the improvement appears lower than advanced hybrid closed loop systems. This system is effective to prevent hypoglycaemia. • The psychosocial effects remain less understood in terms of improvement of psychosocial outcomes. The system has been considered to provide flexibility and independence by the patients and their caregivers. The workload required to use this system is perceived as a burden by the patients who decrease the use of auto-mode functionality over time.

Project description:Background: The coronavirus disease 2019 (COVID-19) pandemic has challenged the ability to do face-to-face training on advanced diabetes management technologies. In the United States, Medtronic Diabetes shifted from occasional to 100% virtual training on all diabetes devices in mid-March 2020. We studied the outcomes of virtual training on the MiniMed™ 670 G hybrid closed-loop system in type 1 diabetes. Methods: From March 20, 2020, to April 22, 2020 (intra-COVID-19), virtual training on the MiniMed 670 G system was completed using Zoom with satisfaction captured through online post-training surveys. Training efficiency was measuring by the days between the date of product shipment and the date of the first and final trainings. Patient satisfaction with training on the MiniMed 670 G was determined by Net Promotor Score® (NPS®). Uploads from CareLink™ Personal and CareLink Professional and calls to the Medtronic 24-h technical support team requesting educational/software assistance and/or help with health care provider telehealth visits were recorded. Continuous glucose monitoring (CGM) results were measured using the CareLink Personal database. All results except for the Zoom satisfaction survey were compared with data from January 20, 2020, to February 22, 2020, (Pre-COVID-19) when training was performed in-person. Results: The CGM metrics were comparable between pre- and intra-COVID-19 training. The Zoom video conferencing application had 98% satisfaction. The NPS rose from 78 to 84. The time between the pump shipment and the first and last (automode) training was significantly reduced from 14 ± 7 days to 11 ± 5 days (P < 0.001) and from 19 ± 7 days to 15 ± 15 days (P < 0.01), respectively. There was a decrease in the calls for educational assistance to the technical support team but an increase in requests for login and software installation support. Conclusions: Virtual training of individuals with diabetes on the MiniMed 670 G system resulted in high satisfaction and short-term glycemic results comparable with in-person training.

Dataset Information

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.

Publications

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.

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