American Diabetes Association 78th Scientific Sessions:

Data Supports Efficacy of Omnipod DASH Over Standard Care

A robust research presence, aimed at demonstrating the efficacy of the Omnipod DASH insulin management system (Insulet)—which gained FDA 510(k) clearance in early June—was delivered for attendees at the American Diabetes Association 78th Scientific Sessions in Orlando, Florida, with data from 10 abstracts, three oral presentations, and six posters.

The Omnipod DASH system is the only wearable, tubeless, closed-loop insulin delivery product, currently available only for investigative use.

“We envision for our commercial product that the information will go directly from the Dexcom pump directly to the Omnipod DASH System which will house our algorithm to individualize insulin delivery,” Trang T. Ly, MBBS, PhD, senior author, who is a pediatric endocrinologist and medical director at Insulet Corporation. 

Here are highlights of several key presentations, most of which were led by the leaders in diabetes research:

Omnipod DASH proves favorable in real-living settings and during exercise.

Omnipod Personalized Insulin Delivery Well Received

“The research we are presenting at ADA is from our five-day study of adults, but it was also studied in adolescents, and children ages 6 years and older with equally promising results,”1-3 Dr. Ly told EndocrineWeb.

A pilot trial of the Omnipod personalized model predictive control algorithm was carried out with adults who had established type 1 diabetes and who wore the Omnipod.1 The aim was to demonstrate the safety and efficacy of the system in a real-life setting.

Eleven adults, ages 28.8 +/- 7.9 years, whose average disease duration was 14.9 years, with a hemoglobin A1c (HbA1c) of 7.4 +/- 1.2% were enrolled.1 In the first phase, all participants followed a seven-day phase-in protocol using standard therapy (either an insulin pump [n=or multiple daily injections) plus a pump at home.1

Housed at a hotel and under supervision to assure standardization of the protocol, the second phase, lasting five days, consisted of participants consume meals without any restrictions and were prompted to be physically active for a minimum of 30-minutes daily while using the Omnipod system.1

The researchers found that time-in-range improved 11.2% over the five-day free-living experiment for those using the hybrid closed loop (HCL) system in comparison to standard therapy (73.7% versus 62.5%, respectively).Even more impressive was the increase in overnight time-in-range of 13.2%, (73.9 HCL versus  60.7% for those following standard therapy), according to co-author, Bruce A. Buckingham, MD, professor of pediatrics, endocrinology, and diabetes at Stanford University School of Medicine in California.

In addition, the participants using the hybrid closed-loop system experienced reduced hypoglycemia, which together with the findings demonstrating the safety and performance of the Omnipod system while supporting greater freedom in patients daily activities,1 Dr. Buckingham reported.

“The data is extremely favorable and promising as we were able to show that with closed-loop therapy, our innovative algorithm is meaningful and brings benefit to patients by allowing patients to spend greater time-in-range and less time spent in a hypoglycemia range in comparison to the those on multiple dose insulin injection therapy,” said Dr. Ly, “It promises great value and benefit for our patients.”

 

VIVID Trial Supports Use of Concentrated Insulin in Omnipod System

Findings from the first randomized, prospective trial to examine the efficacy and safety of Humulin-R  U500 use in the Omnipod insulin management system was presented at the 2018 ADA annual meeting.4

Three hundred and forty patients with type 2 diabetes were enrolled in this 26-week, multicenter, open-label, parallel trial; patients receiving GLP-1 RAs or SGLT-2s were excluded from this analysis and reported separately.5 Participants received about 290 units a day.

“Our VIVID study, using U-500 (Lilly)—which delivers five times as much insulin per 1 mL as standard insulin unit—in the Omnipod pump, was initiated out of a need to amass evidence of benefit among patients who have been using the concentrated insulin off-label to date,” Dr. Ty told EndocrineWeb.

The incidence, rates, and severity of hypoglycemia were similar for both groups higher for CSII group for nocturnal hypoglycemia, which suggests that individualized treatment will be essential when using the Omnipod, unlike in the study where the initial settings were set by the protocol,4 said presenting author, George Grunberger, MD,  clinical professor at the Wayne State University School of Medicine and chairman of the Grunberger Diabetes Institute, in Bloomfield Hills, Michigan.

"Once approved, the Omnipod will give patients on R U500 another way to manage their diabetes, and hopefully, with better control using less insulin, without the need for multiple injections,"  told EndocrineWeb.  

Omnipod insulin delivery resulted in a greater HbA1c reduction at a lower daily dose. However, overall rates of hypoglycemia (< 54 mg/dL) and weight gain were similar between the groups, and overnight rates of hypoglycemia were statically higher in patients using the Omnipod insulin pump in comparison to standard injection therapy,4 said Dr. Grunberger

Of note, the patients using the Omnipod experienced greater efficacy at lower doses than those on standard MDI therapy, suggesting that the Omnipod system with U-500R may be a viable option for T2D patients who are on high-dose insulin,4 he said. As such, clinical determination of individualized dosing will be needed to achieve HbA1c targets.

Impact of DASH on Glycemic Control During Exercise

“A study conducted at York University6 evaluated different way of reducing insulin to achieve optimal blood sugar levels during exercise,” said Dr. Ly. “What we were able to show is that when basal insulin was reduced between 50—80% in the 90 minutes before exercise, the incidence of hypoglycemia that occurs during exercise was significantly reduced.”

When people with type 1 diabetes plan to exercise, the guidelines direct them to reduce their basal insulin 60 to 90 minutes prior to engaging in physical activity.7 This is particularly challenging for athletes who try to maintain stable blood sugars even on exertion.x

To evaluate the efficacy of using a CSII, the Omnipod was given to 13 patients in this randomized, cross-over study to assess three pre-exercise rates of basal insulin reduction.6  The participants walked for 60 minutes, and 90 minutes prior to exercise they received a reduction in insulin of 80%, 50%, and a 100% at the initiation of walking.

Blood glucose levels were similar prior to exercise as well as at meals in all groups. However, the mean change in blood glucose during walking was greatest when the participants reduced their insulin by 100% at the start of exercise, with 54% (n=7) experiencing hypoglycemia (P < 0.05) as compared to the two other groups in which only one person in each group became hypoglycemic (P < 0.001),6 according to Dessi P. Zaharieva, PhD candidate in kinesiology and health science at York University in Toronto, Canada.

In reporting on the OMNITime results,6 those who reduced their insulin between 50-80% at 90 minutes prior to walking mitigated the risk of hypoglycemia more favorably than that of basal suspension or disconnection at exercise onset, said Ms. Zaharieva. We were able to demonstrate that a reduction in the basal insulin level in advance of exercise did not result in pre-exercise or meal-related rebound hyperglycemia, she said.

In describing the potential to change diabetes care for both clinicians and their patients, the varied patient populations and conditions under which the Omnipod system was tested lends support to patients looking for a continuous insulin solution to fit their needs and lifestyle, said Dr. Ty.

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