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Feasibility of Outpatient Closed Loop Control With the Bionic Pancreas in Cystic Fibrosis Related Diabetes

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ClinicalTrials.gov Identifier: NCT03258853
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Brief Summary:
The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with cystic fibrosis related diabetes.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis-related Diabetes Device: Bionic Pancreas Other: Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Outpatient Automated Blood Glucose Control With the Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Active Comparator: Usual Care
Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 7 days. Patients will wear a continuous glucose monitor (CGM) during this arm
Other: Usual Care
Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.

Experimental: Bi-hormonal bionic pancreas (insulin + glucagon)
Bi-hormonal Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 7 days.
Device: Bionic Pancreas
Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.

Experimental: Insulin only bionic pancreas
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin only using a continuous glucose monitoring (CGM) device, for 7 days.
Device: Bionic Pancreas
Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.




Primary Outcome Measures :
  1. Average continuous glucose monitor (CGM) glucose values [ Time Frame: Days 3-7 ]
    Average blood glucose measured by continuous glucose monitor

  2. Time with CGM glucose < 54 mg/dl [ Time Frame: Days 3-7 ]
    Time spent with CGM glucose reading < 54 mg/dl


Secondary Outcome Measures :
  1. Fraction of time spent with blood sugar: < 50 mg/dl, < 60 mg/dl, < 70 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl [ Time Frame: Days 3-7 ]
    Time spent with CGM glucose in each of these ranges

  2. Number of episodes of symptomatic hypoglycemia [ Time Frame: Days 3-7 ]
    Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)

  3. Percentage of subjects with mean CGMG <154 mg/dl [ Time Frame: Days 3-7 ]
    Percentage of subjects who achieve a mean CGM glucose < 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age ≥ 18 years and have had a diagnosis of CFRD managed using either an insulin pump or multiple daily injections (insulin dose must be ≥0.1u/kg/day)
  • Live within a 120 minute drive-time radius of the central monitoring location
  • Willing to remain within a 250 mile radius of the central monitoring location throughout the study. No air travel will be allowed due to the inability to remotely monitor patients while they are flying.
  • Willing to wear one or two infusion sets and one Dexcom CGM sensor and change sets frequently (at least one new glucagon infusion set daily during bi-hormonal arms, and insulin infusion set every other day throughout the study)
  • Have a mobile phone they will have access to at all times throughout the study for making contact with study staff
  • 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)

No subjects will be excluded on the basis of gender or race.

Exclusion Criteria

  • 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 HCG), breast feeding, plan to become pregnant in the immediate future, 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 pill (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

  • Need to go outside of the designated geographic boundaries during the study
  • Current alcohol abuse (intake averaging >3 drinks daily in last 30 days) 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 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 severe 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 (eGFR<30)
  • 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)
  • Abnormal EKG consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal LAD critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.
  • Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea)
  • History of TIA or stroke
  • Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
  • History of hypoglycemic seizures (grand-mal) or coma in the last year
  • History of pheochromocytoma: fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:

    • Episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension
    • Paroxysms of tachycardia, pallor, or headache
    • Personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
  • History of adrenal disease or tumor
  • Hypertension with systolic BP ≥160 mm Hg or diastolic BP ≥100 despite treatment
  • Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.
  • Unable to completely avoid acetaminophen for duration of study
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
  • Established history of allergy or severe reaction to adhesive or tape that must be used in the study
  • History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
  • History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
  • Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, DPP-4 inhibitors, SGLT-2 inhibitors) or non-insulin injectable (GLP-1 agonists, amylin) anti-diabetic medications
  • Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)
  • Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study
  • Currently receiving (or likely to need during the study period): immunosuppressant therapy, chemotherapy, anticoagulant/antithrombotic therapy (excluding aspirin).
  • History of lung or liver transplant
  • Anticipated lung transplant (on transplant list)
  • No acute pulmonary exacerbation or hospitalizations within the past 4 weeks or treatment with IV antibiotics in the past 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258853


Contacts
Contact: Courtney A Balliro, BS, RN, CDE 617-726-1242 cballiro@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Courtney Balliro, RN, CDE    617-726-1242    CBALLIRO@PARTNERS.ORG   
Principal Investigator: Steven J Russell, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Boston University
Investigators
Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital

Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03258853     History of Changes
Other Study ID Numbers: 2017P001839
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Steven J. Russell, MD, PhD, Massachusetts General Hospital:
cystic fibrosis
insulin
glucagon
continuous glucose monitor
bionic pancreas

Additional relevant MeSH terms:
Diabetes Mellitus
Fibrosis
Cystic Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Insulin, Globin Zinc
Insulin
Pancrelipase
Pancreatin
Glucagon
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins