Medtronic announced earlier this month, the enrollment of the first study participants in the company’s pivotal trial of its Bluetooth® enabled MiniMed(TM) 780G advanced hybrid closed loop (AHCL) system.
According to the company, this next-generation system is designed to automate the delivery of correction boluses when the user experiences, or is predicted to experience, prolonged high glucose levels based on their sensor readings.
The trial will look at the safety of the MiniMed 780G system in participants with Type 1 diabetes at home, at work, during exercise and other daily activities.
The study will enroll up to 350 adult and pediatric participants.
“We are excited to begin enrollment in this trial as we continue to advance our phased approach towards the development of a fully closed-loop system,” said Dr. Robert Vigersky, chief medical officer for the diabetes group at Medtronic. “The MiniMed 780G system is designed to take our MiniMed 670G system with automated basal insulin delivery one step further so that people living with Type 1 diabetes can enjoy greater freedom and less burden from their daily diabetes management.”
Vigersky added, forgetting a pre-meal bolus can lead to hyperglycemia and as much as people try to remember to take a pre-meal bolus or to accurately calculate their carbohydrates, real life sometimes gets in the way.
“As we evaluate this next-generation system, our goal is to increase automation through smart algorithms that reduce the need for patient interaction and decision-making,” he said.
Positive Data from Early Results
Data from the feasibility study demonstrated the safety of the system and its potential to improve overall glycemic control and simplify diabetes management for individuals who forget to administer a bolus of insulin at mealtime, carb count inaccurately or choose to forgo announcing meals.
Additionally, hypoglycemia (time spent below 70mg/dL) dropped by 27% and hyperglycemia (time spent above 180 mg/dL) was reduced by 14% with no serious adverse events reported.
“The early results are positive and I look forward to evaluating the system in more patients as part of the pivotal trial as the technology holds significant promise for the diabetes community,” said Dr. Robert Slover, director of pediatrics at the Barbara Davis Center for Diabetes and co-principal investigator of the study.
“Managing diabetes on a daily basis is a tremendous burden and responsibility so I’m very pleased to see advancements being made in the space that will enable technology to safely automate more of these decisions on behalf of patients so they can think less about their disease,” he added.
Data on the study were shared at the 79th Scientific Sessions of the American Diabetes Association, in San Francisco, June 7-11, 2019.
For more details, including enrollment information for the clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT03959423
Feature image: The MiniMed 670Gsystem. Image courtesy: Medtronic.
- Medtronic. (2019, June 8). Medtronic Initiates Pivotal Trial for Bluetooth Enabled MiniMed(TM) 780G Advanced Hybrid Closed Loop System Designed to Automate Correction Bolusing. Retrieved June 8, 2019, from http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2400974