The Bihormonal iLet Bionic Pancreas Feasibility Study

NCT03840278 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 2 other identifiers: 2019P00025219-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.

Conditions

Type 1 Diabetes Mellitus

Keywords

bionic pancreas; closed loop; glucagon; insulin

Outcome Measures

Primary Outcomes (3)

• Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas

  Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.

  Days 1-7

• Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available

  Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.

  Days 1-7

• The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon

  Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.

  Days 1-7

Secondary Outcomes (4)

• Proportion of Time With CGM Glucose < 54 mg/dl

  Days 2-7

• Mean Continuous Glucose Monitor Glucose Concentration

  Days 2-7

• Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl

  Days 2-7

• Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)

  Days 1-7

Study Arms (2)

Bihormonal iLet first, then Insulin-Only iLet

EXPERIMENTAL

Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For this sequence, participants first used the bihormonal iLet bionic pancreas for 1 week. They then used the insulin-only iLet bionic pancreas for 1 week.

Device: Bihormonal iLet Bionic Pancreas; Drug: Dasiglucagon

Insulin-Only iLet first, then Bihormonal iLet

EXPERIMENTAL

Each sequence of the study will use the iLet Bionic Pancreas. The iLet is an autonomous infusion pump controlled by the bionic pancreas control algorithm that calculates and doses insulin and/or dasiglucagon based on glucose values received by the Dexcom G5 Continuous Glucose Monitor (CGM). For this sequence, participants first used the insulin-only iLet bionic pancreas for 1 week. They then used the bihormonal iLet bionic pancreas for 1 week.

Device: Insulin-only Bionic Pancreas

Interventions

Bihormonal iLet Bionic Pancreas DEVICE

Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon

Bihormonal iLet first, then Insulin-Only iLet

Insulin-only Bionic Pancreas DEVICE

Insulin-only iLet Bionic Pancreas using just insulin

Insulin-Only iLet first, then Bihormonal iLet

Dasiglucagon DRUG

Experimental stable glucagon for use in the iLet Bionic Pancreas

Bihormonal iLet first, then Insulin-Only iLet

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
• Diabetes managed using an insulin pump for ≥ 3 months
• Prescription medication regimen stable for \> 1 month (except for medications that will not affect the safety of the participant and are not expected to affect any outcome of the study, in the judgement of the principal investigator)
• Willing to wear one Dexcom CGM sensor, and up to two steel cannula infusion sets (6 mm Contact Detach) and change infusion sets frequently (if the subject is known not to tolerate steel infusion sets then a plastic set may be used)
• Have used a CGM for at least one cumulative month over the last 24 months
• Willing to stay within a 250-mile radius of the designated base throughout the study. Air travel is not permitted.
• Informed consent obtained before any trial-related activities
• Have a designated contact (an adult ≥ 18 years of age) willing to serve as an emergency contact for them throughout the study.

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 iLet, impaired memory, unable to speak and read English)
• Current participation in another clinical trial with administration of investigational drug.
• 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
• Previous exposure to dasiglucagon (otherwise known as ZP4207)
• Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 12 months, or sexually active without use of contraception
• Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
• Acceptable contraception methods include:Oral contraceptive pills (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as Nuvaring), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
• 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)
• Renal failure on 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
• Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
• History of TIA or stroke in the last 12 months

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beta Bionics, Inc.: collaborator
• Zealand Pharma: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Castellanos LE, Balliro CA, Sherwood JS, Jafri R, Hillard MA, Greaux E, Selagamsetty R, Zheng H, El-Khatib FH, Damiano ER, Russell SJ. Performance of the Insulin-Only iLet Bionic Pancreas and the Bihormonal iLet Using Dasiglucagon in Adults With Type 1 Diabetes in a Home-Use Setting. Diabetes Care. 2021 Jun;44(6):e118-e120. doi: 10.2337/dc20-1086. Epub 2021 Apr 27. No abstract available.

  PMID: 33906916 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Courtney A Balliro, BS, RN, CDE
• Organization: Massachusetts General Hospital Diabetes Research Center

cballiro@partners.org

617-726-1242

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: The study follows a 2-treatment, 2-period crossover design, 2 and will consist of two 7-day study arms in random order: one bihormonal bionic pancreas arm using insulin lispro or insulin aspart and dasiglucagon, and one insulin-only bionic pancreas arm using insulin lispro or insulin aspart.

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: May 15, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: December 16, 2019
• Results First Posted: December 16, 2019

Record last verified: 2019-11

Locations

US (1)