iLet© Bionic Pancreas Updates
Data presented at the recent American Diabetes Association 82nd Scientific Sessions this week show promising results for Beta Bionics, Inc.’s system, the iLet© Bionic Pancreas.
The name of the trial, Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT), reflects that this version of the iLet© only contains insulin. The next version Beta Bionics plans to study is a dual hormone system that provides glucagon and insulin.
iLet© Bionic Pancreas is designed to improve ease of use and reduce the tediousness of standard of care T1D management. The system allows people to select ‘normal, small, big’ meal types as the bolus input message compared to the normal method of tallying up all carbohydrates that a person plans to consume. Additionally, the system has no ‘warm up’ or ‘data gathering’ ramp-up time. It is designed to be programmed and then started up with the first sensor and infusion set worn. The programming only requires body weight. It does not require someone to already know their ideal basal rates, carb to insulin ratios, or correction factors. The system is designed to automatically titrate and infuse appropriate insulin doses.
Beta Bionics’ mission is to help improve health outcomes and the quality of life of children and adults living with diabetes and other conditions of glycemic dysregulation. The company operates out of Massachusetts and California.
A total of 440 people enrolled in the study. Study participants had Type 1 Diabetes and were 6 years of age or older. 326 adults and children using Novolog® or Humalog® were divided into a standard of care group or the iLet© group. One subgroup of 114 participants used the iLet© with ultra-rapid acting insulin Fiasp®.
The trial studied the efficacy of the iLet© Bionic Pancreas compared to the standard of care.
The standard of care group was divided into thirds.
- One-third used an Automated Insulin Delivery (AID) system (such as Medtronic’s or Tandem’s) which is an insulin pump that adjusts doses based on an algorithm and a continuous glucose monitor (CGM).
- One-third wore an insulin pump and standalone CGM that do not communicate to auto-adjust doses.
- One-third of the group did multiple daily injections with CGM.
A few interesting facts about the IO BPPT include:
- The study took place in the home instead of in laboratory-controlled environment
- 10% of the study participants were Hispanic or Latino, 10% were Black non-Hispanic, and 6% were more than one race or ‘other’ race
- The study included a bigger variety of ages, ethnicities, and baseline (pre-study) A1Cs than other AID studies have included
- 16 centers nationwide participated in the study
- The study was subdivided to review efficacy of standard of care options to the iLet, but also subdivided to review differences based on age (kids, teens, adults), and between iLet with Humalog® or Novolog® to iLet© with Fiasp®
The iLet© IO BPPT results showed:
- Adults using the iLet© achieved 11% more time in range at the 13 weeks compared to adults in the standard of care groups
- The parents of the children with T1D reported greater satisfaction with the treatment methodology compared to the standard of care options
- At the 13-week time point in the study for the 161 adults taking Humalog or Novolog with a baseline average A1C of 7.6%:
- The average A1C for the adults in the iLet© group dropped to 7.1%
- The average A1C drop for those in the standard of care groups dropped to 7.5%
- The difference between the two groups is (P < .001) clinically significant.
- The average dropped by 0.7% if the baseline A1C was higher than
- The average A1c drop for those with a baseline A1c of >7% was 0.7%
- Increased time in range of 11% (2.6 hours per 24 hours)
- NO increase in hypoglycemia for any of the age groups
The outcomes look very positive.
This device could open the pathway to help reduce some of the current gap in care between people with differences in socio-economic classes and education levels. It can also improve glucose management outcomes and quality of life for a wide age range.
Watch for updates in the fall/winter regarding the anticipated iLet© dual hormone (insulin + glucagon) study.
If you have diabetes, make time for DSME and discover these benefits for yourself.
We here at Integrated Diabetes Services can meet your individual needs. Our diabetes educators focus on a variety of specialties. Some of these include education for newly diagnosed, type 1 and pregnancy, optimizing use of devices, weight loss for insulin users, as well as insulin management for athletes.
For more information or to get involved in DSME, call 877-735-3648 (in N America) or +1 (610) 642-6055 (outside N America).
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