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

NCT04112069 | Completed Results DMC FDA Device

• 1 other identifier: 2018P000853/JCHR
• Study Type: interventional
• Target: 20
• 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 pediatric 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

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

  Days 2-5

• Percentage of Time With CGM Glucose Values <54 mg/dl

  Days 2-5

Other Outcomes (6)

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

  Day 2-5

• Percentage of Time in the Glucose Target Range of 70-180 mg/dl

  Days 2-5

• Percentage of Time Where CGM Glucose is Greater Than 250 mg/dL

  Day 2-5

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Participants randomized to usual care first started the usual care arm (UC) managing their diabetes with continuous subcutaneous insulin infusion (pump therapy) for approximately 5 days. All subjects wore a Dexcom G5 continuous glucose monitor (CGM). If randomized to the usual care arm first, subjects crossed over to the bionic pancreas arm following a 2-day washout period.

Other: Usual Care

iLet Bionic Pancreas with 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) for approximately 5 days. All subjects wore a Dexcom G5 CGM. If randomized to the bionic pancreas arm first, subjects crossed over to the usual care arm following a 2-day washout period.

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

Interventions

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

iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

iLet Bionic Pancreas with Humalog or Novolog

Usual Care OTHER

Usual care

Usual care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• Age 6-17 years
• 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

You may not qualify if:

• 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
• Current alcohol abuse (intake averaging \>4 drinks daily in last 30 days) or other substance abuse (use within the last 3 months of controlled substances other than marijuana without a prescription)
• Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
• Stage 4 renal failure (eGFR \<30) or Stage 5 renal failure on dialysis (hemodialysis or peritoneal dialysis)
• History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
• Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
• EKG is only required for participants ≥50 years old or with diabetes duration ≥20 years

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Courtney Balliro, BS, RN, CDE
• Organization: Mass. General Hospital

cballiro@partners.org

617-726-1242

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: September 30, 2019
• First Posted: October 2, 2019
• Study Start: July 9, 2018
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: February 5, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)