Steven J. Russell, United States of America

Massachusetts General Hospital Diabetes Research Unit

Presenter of 3 Presentations

 Conference Calendar

USE OF THE ULTRA-RAPID INSULIN FIASP IN THE ILET BIONIC PANCREAS

Session Name
ARTIFICIAL PANCREAS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:50 - 09:51
Presenter
Authors

Abstract

Background and Aims

We evaluated the function of the insulin-only iLet bionic pancreas delivering Fiasp vs. iLet delivering insulin lispro or aspart vs. usual care in a home-use study in adults on pump and MDI therapy with type 1 diabetes.

Methods

We performed a 3-way, random-order cross-over, home use study comparing the iLet delivering Fiasp (iLet-F) vs. the iLet delivering insulin lispro or aspart according to the usual-care insulin (iLet-LA) vs. usual care (UC) for 7 days each. Bionic pancreas sessions were initiated by entering only the body weight; the iLet autonomously and continuously adapts to individual insulin needs. The PK setting in the iLet algorithm was not adjusted for Fiasp.

Results

The mean CGMG in the iLet-F arm (155±11, p=0.042), but not in the iLet-LA (155±13, p=0.097), was significantly lower than in the UC arm (162±26). There was no difference in mean CGMG between the iLet-F and iLet-LA arms (p=0.64). There were no differences in median % time <54 mg/dl between the arms (0.49 [0.0,1.0] vs. 0.53 [0.2,1.0] vs. 0.35 [0.1,1.2], p>0.64). The % time in range was greater in the iLet-F (70.6±8.1%, p=0.001) and iLet-LA (70.1±9.2%, p=0.006) arms vs. the UC arm (61.5%). There was no difference between the iLet-F and iLet-LA arms (p=0.54). There were no differences in mean insulin TDD between arms (p>0.45).

Conclusions

The iLet can provide effective glucose control when delivering Fiasp, insulin aspart, or insulin lispro. Adjustment to the PK settings of the iLet may be necessary to further improve glycemic outcomes with Fiasp.

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HOME USE OF THE ILET BIONIC PANCREAS IN THE BIHORMONAL CONFIGURATION USING DASIGLUCAGON VERSUS THE INSULIN-ONLY CONFIGURATION IN ADULTS WITH TYPE 1 DIABETES

Session Name
E-POSTER DISCUSSION 02
Session Type
E-POSTER DISCUSSION
Date
20.02.2020, Thursday
Session Time
10:05 - 10:25
Channel
Station 2 (E-Poster Area)
Lecture Time
10:20 - 10:25
Presenter
Authors

Abstract

Background and Aims

We evaluated the function of the bihormonal iLet bionic pancreas delivering dasiglucagon when compared to the insulin-only iLet in a home-use study in adults with T1D.

Methods

Ten subjects used the bihormonal and insulin-only configurations of the iLet for one week each in random order. The bihormonal iLet delivered 4 mg/dl dasiglucagon, a glucagon analog stable in aqueous solution (Zealand Pharma). Sessions were initiated by entering the body weight; the iLet autonomously and continuously adapts to individual insulin needs. The primary outcome was iLet performance targets: CGM glucose (CGMG) readings capture ≥80%, drug delivery channel(s) availability ≥95%, and ratio of delivered to attempted doses 0.95 to 1.05. Secondary outcomes included measures of glycemic control.

Results

The iLet met the specified performance targets in both configurations. For the bihormonal vs. insulin-only configuration median percent time with CGMG < 54 mg/dL was 0.2% [0,0.3] vs. 0.6% [0.2,1.1] (p=0.16); mean daily carbohydrate to treat hypoglycemia was 13.0±9.6 vs. 16.1±13.0 grams/day; mean CGMG was 139±11 vs. 149±13 mg/dL (p <0.01); mean percent time within the 70-180 mg/dl range was 79±9% vs. 71±8% (p<0.01); and percentage of subjects with mean CGMG <154 mg/dl was 90% vs. 50%. There were no infusion set occlusions or site reactions.

Conclusions

The iLet performed to specifications in both the bihormonal and insulin-only configurations. Glycemic outcomes were very similar to those achieved with previous hardware implementations of the bionic pancreas. Dasiglucagon was well tolerated and the bihormonal iLet achieved similar glycemic outcomes to those previously achieved with freshly reconstituted human glucagon.

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INVESTIGATING THE SAFETY AND GLYCAEMIC CONTROL OF FAST-ACTING INSULIN ASPART WITH A CLOSED-LOOP DELIVERY SYSTEM IN ADULTS WITH TYPE 1 DIABETES

Session Name
ORAL PRESENTATION SESSION 07
Session Type
ORAL PRESENTATION SESSION
Date
22.02.2020, Saturday
Session Time
08:30 - 10:00
Channel
London
Lecture Time
09:10 - 09:20
Presenter
Authors

Abstract

Background and Aims

Combining the bionic pancreas (iLetTM) with fast-acting insulin aspart (faster aspart) is of interest given the improved pharmacological and glycaemic profile of faster aspart versus conventional rapid-acting insulin analogues. We investigated the safety and glycaemic control of the insulin-only configuration of the iLetTM delivering faster aspart using different algorithm tmax settings in adults with type 1 diabetes.

Methods

We performed a single-centre, single-blind, crossover (two 7-day treatment periods) escalation trial over three sequential cohorts in which subjects were randomised to a default tmax (t65) setting followed by a non-default tmax setting (t50 [cohort 1], t40 [cohort 2], t30 [cohort 3]), or vice versa, all with faster aspart. Each cohort randomised eight new subjects if escalation stopping criteria were not met in the previous cohort.

Results

Two subjects discontinued treatment, one due to “low blood glucose” during the first treatment period of cohort 3 (t30). No severe hypoglycaemic episodes were reported and there were no clinically significant differences in adverse events between groups. Mean time in low (sensor) glucose (<54 mg/dL, primary endpoint) was <1.0% for all tmax settings (Table). Except for the default tmax setting in cohort 1, the mean time in range (70–180 mg/dL) was >70%. Mean glucose in cohorts 1 and 2 was significantly lower at non-default versus default tmax settings, with comparable insulin dosing.

Conclusions

There were no safety concerns with faster aspart in the iLetTM at non-default tmax settings. Improvements in glycaemic control at non-default tmax settings were observed.

1129373 - 4360 bionic pancreas new abstract table.png

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