NCT04112069

The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study

Completed NA Results posted Last updated 5 February 2020

What this trial tests

NA trial testing iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog in Type1 Diabetes Mellitus in 20 participants. Completed in 19 November 2018.

Timeline

9 July 2018

Primary endpoint
19 November 2018

19 November 2018

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	9 July 2018
Primary completion	19 November 2018
Estimated completion	19 November 2018
Sites	3 locations across United States

Drugs / interventions tested

• iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
• Usual Care

Conditions studied

• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →

Sponsor

Massachusetts General Hospital

Who can join

Adults 6 to 17, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean CGM Glucose Primary · Days 2-5

Mean of all CGM data obtained with the Dexcom G5 through days 2-5 of the study

Group	Value	95% CI
Usual Care	159	± 27
iLet Bionic Pancreas With Humalog or Novolog	163	± 15

Percentage of Time With CGM Glucose Values <54 mg/dl Primary · Days 2-5

Group	Value	95% CI
Usual Care	0.1	0.0 – 0.4
iLet Bionic Pancreas With Humalog or Novolog	0.4	0.1 – 0.9

Percentage of Time Where CGM Glucose is Less Than 70 mg/dL Secondary · Day 2-5

Group	Value	95% CI
Usual Care	2.1	0.7 – 5.1
iLet Bionic Pancreas With Humalog or Novolog	1.7	1.2 – 2.8

Percentage of Time in the Glucose Target Range of 70-180 mg/dl Secondary · Days 2-5

Group	Value	95% CI
Usual Care	65	± 15
iLet Bionic Pancreas With Humalog or Novolog	65	± 10

Percentage of Time Where CGM Glucose is Greater Than 250 mg/dL Secondary · Day 2-5

Group	Value	95% CI
Usual Care	9	3 – 12
iLet Bionic Pancreas With Humalog or Novolog	9	5 – 13

Percentage of Time Where CGM Glucose is Less Than 60 mg/dL Secondary · Day 2-5

Group	Value	95% CI
Usual Care	0.5	0.3 – 1.4
iLet Bionic Pancreas With Humalog or Novolog	0.6	0.4 – 1.2

Number of Episodes of Severe Hypoglycemia Secondary · Day 1-5

Pre-specified to report the total number of episodes summed across all participants

Group	Value	95% CI
Usual Care	3
iLet Bionic Pancreas With Humalog or Novolog	6

Number of Episodes of Diabetic Ketoacidosis (DKA) Secondary · Day 1-5

pre-specified to report the total number of episodes summed across all participants

Group	Value	95% CI
Usual Care	0
iLet Bionic Pancreas With Humalog or Novolog	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 months for the RCT (Randomized control trial). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care

Serious: 0/20 (0%)

Deaths: 0/20

iLet Bionic Pancreas With Humalog or Novolog

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Usual Care	iLet Bionic Pancreas With …
Hyperglycemia	Endocrine disorders	—	—

Data from ClinicalTrials.gov NCT04112069 adverse events section.

Sponsor's own description

The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas. The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation.

This is a multicenter study of pediatric participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Insulin-delivery methods for children and adolescents with type 1 diabetes.
   Zuberi Z, Sauli E, Cun L, Deng J, et al · · 2020 · cited 14× · PMID 32944212 · DOI 10.1177/2042018820906016