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ORLANDO – Three new experimental "closed-loop hybrid" insulin delivery systems are promising for improving blood glucose levels in people with type 1 diabetes.
The results for the three systems – the tube without Omnipod (Insulet) closed-loop hybrid system (Horizon Automated Glucose Control System), the Diabeloop enriched in artificial intelligence DBLG1 system, and the double-hormone system – were all presented on June 24 here at the American Diabetes Association (ADA) 2018 scientific sessions.
Hybrid closed loop refers to systems that combine insulin pumps, continuous glucose monitors (CGM) and an algorithm that allows the two devices to interact so that the pump adjusts the insulin distribution accordingly. CGM readings. But they are called hybrids because, until now, these systems can not fully automatically counteract post meal mealtime spikes or prevent any episodes of hypoglycemia. The term artificial pancreas is also used loosely to refer to these systems.
The new data was discussed at a press conference moderated by Irl B. Hirsch, MD, of the University of Washington, Seattle.
"From my point of view, these are all new and exciting advances in diabetes technology, especially for people with type 1 diabetes," he said.
However, he also responded to the generally raised concern that these technologies may take a long time to reach the majority of patients with type 1 diabetes. "I worry about this when I see my own patients," Hirsch said, noting that only 30% of patients with type 1 diabetes in the United States use insulin pumps, and even in the most successful diabetes centers.
"Without even considering the costs, we need infrastructure and offices for training and follow-up, how can we better deliver these important tools to our patients who need them the most?"
But Hirsch also noted that 80% of patients in his practice now use CGM. One of the major reasons, he said, has been the much improved reimbursement, and in particular the Medicare decision in 2017 to cover CGMs.
And the state of Washington's Medicaid program – as earlier this year – covers the Dexcom CGMs and Free Freestyle for all ages, whereas previously they were only covered for pediatric patients.
"So, I think as long as the repayment continues to be true, we will see increases," he said.
Prototype Omnipod performs in adults in free living conditions
First, a feasibility study of a closed-loop hybrid system using the Omnipod custom predictive control algorithm in 11 adult type-1 diabetics wore the system during their stay in a hotel with unrestricted meals and a daily exercise of moderate intensity. reported by Bruce Buckingham, MD, a pediatric endocrinologist at Stanford University, California.
Compared with the 7 days of prior use of open-loop and CGM separate pumps, overall mean glucose increased from 156 to 150 mg / dL (P = 0.46), with a decrease in time below a glucose level of 70 mg / dL from 5.1% to 1.9% (P = 0.001) and time above 180 mg / dL from 8.5% to 4.5% (P = 0.01).
The results of the night were similar, the time spent below 70 mg / dL having dropped from 5.7% to only 0.7%.
The time in the target glucose range (70-180 mg / dL) was 11.2% higher overall, and 13.2% higher during the night, with closed-loop hybrid care compared to standard care. Hypoglycemia was reduced overall by 3.2% and 5% overnight.
"Additional longer-term studies will evaluate the Omnipod [Model Predictive Control] Algorithm in free living conditions with prolonged use in patients of all ages with type 1 diabetes … The algorithm is continually improved, "said Buckingham.
The French hybrid closed loop could soon reach the European market
Sylvia Franc, MD, of the Sud-Francilien Hospital of Corbeil-Essonnes, France, presented data from the Diabeloop DBLG1 closed-loop system, which uses artificial intelligence to "automate safely decisions Insulin delivery ".
The customizable system allows custom algorithm settings for targets, meals, physical activity and special events, and has telemedicine capabilities.
In a previous study presented at the ADA meeting last year, the system performed well in "difficult situations" such as heavy meals, with a triple improvement in time in the glucose range ( 70-180 mg / dL) overnight.
The present study involved 67 patients, 33 who carried the Diabeloop and 34 their usual pump and CGM (open loop) over 12 weeks under real-life conditions. The time in the target range was 69.3% with the hybrid closed loop versus 56.6% with the open loop (P <.0001). The time below 70 mg / dL was 2% versus 4.5%, respectively, overall (P <0.001), and 1.3% versus 3.9% overnight (P <.0001).
Mean blood glucose dropped from 168.5 to 156.0 mg / dL (P = 0.012).
Patients were very excited about the system, Franc said.
One of them told him, "A big thank you from my family who finally got to sleep peacefully. Another said, "It changed the life of my family and mine … a pure moment of happiness!"
The system has been submitted for CE marking and a decision is expected very soon, Franc says Medscape Medical News
Pramlintide's address to post-meal glucose spikes
Finally, Ahmad Haidar, Ph.D., of McGill University, Montreal, Quebec, presented the results of a hybrid dual hybrid hormone system using insulin and pramlintide, a similar of amylin, a hormone lost in type 1 diabetes with insulin.
Pramlintide slows gastric emptying, suppresses glucagon secretion and promotes satiety. Sold as an injectable under the brand Symlin (AstraZeneca), pramlintide has been approved for about ten years for type 1 and type 2 diabetes.
Haidar and his colleagues felt that the combination of pramlintide with insulin in an automated administration system could overcome the problem of post-meal insulin excursions that persist in most drug systems. Automated administration due to delayed subcutaneous insulin action.
In a randomized crossover study, 12 adults with type 1 diabetes each had a different system for three periods of 24 hours: first a pump with regular insulin plus pancreas artificial pramlintide, followed by fast insulin plus pramlintide artificial pancreas, and finally, a fast insulin -By artificial pancreas.
Separate pumps were used to administer insulin and pramlintide, which were given in a fixed ratio (as if they were co-formulated). Participants consumed three meals and a bedtime snack at a clinical research center.
The time spent between 70 and 180 mg / dL was 86% with fast insulin plus pramlintide, compared with 74% with fast insulin alone (P = 0.001) and 68% with insulin and pramlintide (P = 0.36). Mean glucose levels were 133 mg / dL compared with 142 mg / dL (P = 0.01) and 142 mg / dL (P = 0.79), respectively.
Triple Hormone System at the horizon? Would be "Unbelievable"
During the question and answer period, Haidar said that future research plans are to test a triple-hormone system that includes insulin, pramlintide, and glucagon as a relief of hypoglycemia.
"We hope that companies will look at our data and develop a co-formulation of insulin and pramlintide," said Haider. Medscape Medical News.
Ask by Medscape Medical News For his views on a possible triple hormonal system, Buckingham, who has done extensive research on several types of closed loop systems, said, "I think it's really exciting … you could really brake the rise of glucose with the meal. Being a little more aggressive with insulin because you have glucagon to back it up, you could do without the carbs and a full closed loop system … that would be really amazing. "
But systems that can communicate with each other are needed
However, Hirsch also noted that the onslaught of unique closed-loop systems raises interoperability issues.
"I think one of our goals is to make things interchangeable … It's a problem right now because with every system you have to know the system … And a even more important problem is the download. " Different systems, including Tidepool and Glooko, have been developed to solve this problem and continue to be improved, Hirsch said.
But he added, "We need to do a better job of standardizing the playground so that these systems can all talk to each other, not just for the patient but for the providers."
Hirsch is a consultant for Abbott, ADOCIA, Bigfoot Biomedical and Roche Diabetes Care Health and Digital Solutions. He has received research support from Medtronic MiniMed. Buckingham serves on advisory boards for ConvaTec and Novo Nordisk, is a consultant to Becton, Dickinson and Company, and Tandem Diabetes Care, and has received research support from Dexcom, Insulet, Medtronic, and Tandem Diabetes Care. Frank is a consultant to Animas Corporation, Johnson & Johnson Diabetes Institute and Roche Diabetes Care Health and Digital Solutions. Haidar is a consultant to Eli Lilly and enjoys support in researching AgaMatrix and Medtronic MiniMed.
American Scientific Diabetes Association 2018 Scientific Sessions. June 22, 2018; Orlando Florida. Abstract 207-OR, 208-OR, 210-OR.
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