Artificial Pancreas Performs Well in Type 2 Diabetic Inpatients

Marlene Busko

June 21, 2016

NEW ORLEANS — A small pilot study showed that, during a short hospital stay mainly for foot-ulcer complications, glucose levels of patients with type 2 diabetes who were on insulin were better managed by a closed-loop insulin-delivery system (artificial pancreas) than by subcutaneous insulin injection by nurses.

Compared with 20 patients who received standard care, 20 patients who received a fixed insulin dose, with no boluses, via the automated closed-loop delivery system had glucose levels that were more often within the recommended target range during their hospital stay, with no adverse effects.

"This study showed that automated subcutaneous closed-loop insulin delivery without meal announcement is feasible and safe in insulin-treated type 2 diabetes in the general ward," Hood Thabit, MD, Cambridge Metabolic Unit, Cambridge University, United Kingdom, summarized, presenting the study here at the American Diabetes Association (ADA) 2016 Scientific Sessions.

This insulin-delivery system "could potentially be an effective and safe tool to manage inpatient hyperglycemia in this particularly underserved population, while easing the burden of healthcare professionals in hospitals," he added.

Whereas this type of insulin-delivery system has shown promise in type 1 diabetic patients, "this is the first time that anyone has done a closed-loop artificial-pancreas study in this [type 2 diabetic] population, mainly because we clinicians are unaware how suboptimally managed patients in the wards are," he told Medscape Medical News.

It's not anyone's fault, he stressed; the healthcare system is simply overly burdened with an increasing number of patients with type 2 diabetes.

However, these are early days, and before this technology is widely adopted on hospital wards, further clinical and cost-effectiveness studies are needed, session cochair Marcus Hompesch, MD, founder, president and CEO of Profil Institute for Clinical Research, in San Diego, California, cautioned to Medscape Medical News.

Extending the Research From Type 1 to Type 2 Diabetes

Over the past decade, Dr Thabit said his group and others have had "good success" with a closed-loop system in patients with type 1 diabetes.

Indeed the first devices are getting closer to official approval in the United States, as Medscape Medical News reported from the ADA meeting.

More recently, Dr Thabit and colleagues studied a closed-loop insulin-delivery system in patients with type 2 diabetes — first in a research setting in a few patients, over a 24-hour period — and then in the current study.

The artificial pancreas comprised CE-mark approved devices, he explained. They used a FreeStyle Navigator II (Abbott Diabetes Care) continuous glucose monitoring (CGM) system (which is available in the United Kingdom, the Netherlands, and Israel) that includes a transmitter that automatically sends glucose readings to a receiver every minute.

The information is sent to an Android tablet fixed to a pole beside the patient's bedside, which then wirelessly instructs a DANA Diabecare R (Advanced Therapeutics UK) pump every 12 minutes to modulate insulin delivery.

In the current study, the researchers enrolled 40 hospitalized patients with type 2 diabetes who were on insulin, excluding patients who had end-stage renal disease, required admission to the intensive care unit, or who were receiving very high glucocorticosteroid doses.

Twenty patients (13 men) were randomized to receive conventional insulin therapy, and the other 20 patients (15 men) received automated subcutaneous closed-loop fixed-dose insulin delivery (without meal bolusing or meal announcement) for 72 hours. The patients in the closed-loop arm also received once-daily insulin glargine at 20% of the prestudy dose, to avoid potential ketosis.

The patients had a mean age of 69 (the oldest was 79) and were obese, with a mean body mass index (BMI) of 33. On average, they had an HbA1c of 8.8%, had had diabetes for 16 years, and had been on insulin for 9 years. Half were taking metformin; 20% were on a sulfonylurea; and 15% were on glucagonlike peptide-1 (GLP-1) receptor agonist therapy.

The primary study end point, the proportion of time when glucose was in the guideline-recommended target range (5.6 to 10.0 mmol/L [100–180 mg/dL]) was 23% higher in the patients in the artificial-pancreas arm vs patients in the standard-therapy arm.

Patients in the artificial-pancreas arm also spent less time in the hyperglycemic range and a similar time below the target glucose range, compared with the other patients.

Time Spent at Target Glucose Levels, Closed-Loop vs Standard Insulin Deliverya
Glucose Target Rangeb Closed-loop insulin delivery, n=20 (%) Conventional insulin therapy, n=20 (%) P
Time within range 61 38 < .0001
Time above range 30 49 .011
Time below range 10 13 .51
a. During a 72-hour hospital stay
b. Glucose target range = 5.6 to 10.00 mmol/L (100 to 180 mg/dL)

Glucose was in the target range for 30% more of the time during the night and for 20% more of the time during the day in the patients who received automated closed-loop insulin delivery compared with the control patients.

The system was designed to be used autonomously without the need for a nurse to administer a bolus or announce a meal, since, "at least in our hospital, our nurses are run off their feet," Dr Thabit said in reply to a question from the audience.

Patients Very Happy With Closed-Loop System

The patients, who had never worn an automated device before, "were very happy to have their glucose controlled by the system," he said in reply to another question.

And in a questionnaire, patients rated the automated insulin-delivery system highly and said that they would recommend it to a friend or family member with diabetes.

The researchers plan to do a larger study that will include patients who were excluded in the current analysis, such as those on dialysis.

In the future, "we envisage this to be used in the inpatient setting for patients who are admitted for other things, such as heart attack or stroke, where it is very important to have their glucose controlled effectively and safely," Dr Thabit concluded.

The study was funded by Diabetes UK, the National Institute for Health Research, and Abbott Diabetes Care. Dr Thabit has no relevant financial relationships; disclosures for the coauthors are listed in the abstract.

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American Diabetes Association 2016 Scientific Sessions; June 11, 2016; New Orleans, Louisiana. Abstract 84-OR


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