The Insulin-Only Bionic Pancreas Bridging Study

NCT03565666 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 2018P000853
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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 adult participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.

Conditions

Type1 Diabetes Mellitus

Keywords

bionic pancreas; closed loop; insulin; continuous glucose monitor

Outcome Measures

Primary Outcomes (2)

• Mean CGM Glucose

  Days 3-7 for the RCT Period

• Percentage of Time Where Glucose is Less Than 54 mg/dL

  Days 3-7 for the RCT Period

Other Outcomes (10)

• Episodes of Severe Hypoglycemia

  Days 3-7 for the RCT Period

• Episodes of Diabetic Ketoacidosis (DKA)

  Days 3-7 for the RCT Period

• Percentage of Time Where Glucose is Less Than 70 mg/dL

  Days 3-7 for the RCT Period

Study Arms (3)

Adult RCT: Usual care

ACTIVE COMPARATOR

Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with either multiple daily injections or continuous subcutaneous insulin infusion (pump therapy) for 7 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM) and half of all subjects also were a senseonics CGM. The usual care period was followed by the other 2 arms according to each subject's randomization schedule

Other: Usual care

Adult RCT: closed-loop control with iLet Humalog or Novolog

EXPERIMENTAL

Participants randomized to the iLet with humalog/novolog first started the insulin-only iLet arm using the insulin analog that they use for their usual care (either Humalog or Novolog). All subjects wore a Dexcom G5 CGM and half of all subjects also wore a Senseonics Eversense CGM. The iLet period was followed by the other 2 arms according to each subject's randomization schedule

Device: iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

Adult RCT: closed-loop control with iLet using Fiasp

EXPERIMENTAL

Participants randomized to the iLet with Fiasp first started the insulin-only iLet arm using faster insulin aspart (Fiasp) in PumpCart, where the pharmacokinetic (PK) parameter for tmax used by the insulin-dosing algorithm was set to the same value as is used for Humalog and Novolog (65 minutes). All subjects wore a Dexcom G5 CGM and half of all subjects also wore a Senseonics Eversense CGM. The iLet period was followed by the other 2 arms according to each subject's randomization schedule

Drug: iLet Bionic Pancreas insulin-only configuration with Fiasp

Interventions

iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog DEVICE

iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

Adult RCT: closed-loop control with iLet Humalog or Novolog

iLet Bionic Pancreas insulin-only configuration with Fiasp DRUG

iLet Bionic Pancreas insulin-only configuration with Fiasp (faster insulin aspart)

Adult RCT: closed-loop control with iLet using Fiasp

Usual care OTHER

Usual care

Adult RCT: Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year
• Diabetes managed using an insulin pump for ≥ 3 months or with multiple daily injections (approximately 1/2 of participants should use a pump and approximately 1/2 should use MDI)
• Age ≥18 years;

You may not qualify if:

• HbA1c level \<11.0%
• A point of care or local lab measurement is used to assess eligibility for screening.
• At least 3 SMBG meter tests daily on average or use of a CGM and 2 or more SMBG meter tests daily on average by history
• For females, not currently known to be pregnant
• If female, sexually active, and at risk for pregnancy, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all women who are post-menarche and pre-menopause who are not surgically sterile. Participants who become pregnant will be discontinued from the study.
• An understanding of and willingness to follow the protocol and sign the informed consent and assent where applicable
• Unable to provide informed consent (e.g. impaired cognition or judgment)
• Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the BP, impaired memory)
• Unable to speak and read English
• Currently using for the first time a real-time CGM for \< 1 month (Individuals who have been using CGM for 1 or more months are eligible)
• Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system
• Current use of insulin glulisine (Apidra) as part of usual diabetes home regimen
• Current off-label use of faster-acting insulin aspart (Fiasp) in CSII therapy as part of usual diabetes home regimen
• Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
• Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 12 months, or sexually active and at risk for pregnancy without use of contraception

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (3)

Stanford University

Palo Alto, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Steven J. Russell
• Organization: Mass. General Hospital

sjrussell@mgh.harvard.edu

617-726-8722

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Study Director

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 21, 2018
• Study Start: July 9, 2018
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3)