A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas

NCT02092220 | Completed Results DMC

• 1 other identifier: Multicenter Study
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes. Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.

Conditions

Diabetes Mellitus Type 1

Keywords

Bionic Pancreas; Insulin; Glucagon; Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (2)

• Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11

  Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.

  Days 2 to 11 of each period

• Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11

  Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL \[3.3 millimoles/liter (mmol/L)\] during Days 2 to 11 was calculated.

  Days 2 to 11 of each period

Secondary Outcomes (22)

• Mean CGMG Values

  Day 1 and Days 1 to 11 in each period

• Percentage of Time With CGMG Concentration by Ranges During Day 1

  Day 1 of each period

• Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11

  Days 1 to 11 of each period

• Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11

  Days 2 to 11 of each period

• Percentage of Participants With Mean CGMG < 154 mg/dl

  Day 1, Days 2 to11, Days 1 to11 of each period

Other Outcomes (5)

• Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM

  11 days

• Number of Unscheduled Infusion Set Replacements

  11 days

• Mean Daily Basal Insulin Dose

  Day 1, Days 2 to 11, each individual day 2 to 11 of each period

Study Arms (2)

Bionic Pancreas

EXPERIMENTAL

Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.

Device: Bionic Pancreas

Usual Care

ACTIVE COMPARATOR

Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.

Device: Insulin pump with or without CGM

Interventions

Bionic Pancreas DEVICE

Bionic Pancreas

Insulin pump with or without CGM DEVICE

Usual Care

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 ≥ 6 months
• Prescription medication regimen stable for \> 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgement of the site principal investigator).
• Employee or student working or studying during most of the week at one of the participating campuses (Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA)
• Lives within a 30 minute drive-time radius of the central monitoring location for one of the study sites
• Willing to remain within a 60 minute drive-time radius of the central monitoring location for one of the study sites during each of the 11-day study arms
• Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)
• Willing to wear two infusion sets and continuous glucose monitor (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)

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 bionic pancreas, impaired memory, unable to speak and read English)
• 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 subject
• Pregnancy \[positive urine human chorionic gonadotropin (HCG)\] breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
• Need to go outside of the designated geographic boundaries during either arm of the study
• Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
• Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
• 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 beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
• History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.
• Renal failure on dialysis
• Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes
• Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)
• Congestive heart failure (CHF) \[established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea\]
• History of transient ischaemic attack (TIA) or stroke
• Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Massachusetts General Hospital (MGH) Diabetes Research Center

Boston, Massachusetts, 02114, United States

Location

UMass Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, Mondesir D, Esmaeili A, Hartigan C, Thompson MJ, Malkani S, Lock JP, Harlan DM, Clinton P, Frank E, Wilson DM, DeSalvo D, Norlander L, Ly T, Buckingham BA, Diner J, Dezube M, Young LA, Goley A, Kirkman MS, Buse JB, Zheng H, Selagamsetty RR, Damiano ER, Russell SJ. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017 Jan 28;389(10067):369-380. doi: 10.1016/S0140-6736(16)32567-3. Epub 2016 Dec 20.

  PMID: 28007348 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Dr Steven J Russell
• Organization: Massachusetts General Hospital

sjrussell@partners.org

617-726-1848

Study Officials

• Steven J Russell, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: November 22, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-10

Locations

US (4)