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

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ClinicalTrials.gov Identifier: NCT03258853
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Beta Bionics, Inc.
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 and children with cystic fibrosis related diabetes.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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 14 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: Insulin only bionic pancreas
Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 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. Percentage of time in glucose target range (70-180 mg/dl) as determined by continuous glucose monitor (CGM) on dasy 3-14 [ Time Frame: Days 3-14 ]
    Percentage of time spent with CGM glucose values between 70 and 180 mg/dl


Secondary Outcome Measures :
  1. Percentage of time spent with CGM glucose: < 54 mg/dl, < 70 mg/dl, > 180 mg/dl, >250 mg/dl [ Time Frame: Days 3-7 ]
    Percentage of 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. Number of subjects with mean CGMG <154 mg/dl [ Time Frame: Days 3-14 ]
    Number 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)

  4. Mean CGM glucose [ Time Frame: Days 3-14 ]
    Average CGM glucose

  5. Number of subjects with percentage of time < 54 mg/dl < 1% [ Time Frame: Days 3-14 ]
    Number of subjects who have less than 1% percent of CGM glucose values < 54 mg/dl

  6. Number of subjects with percentage of time < 54 mg/dl < 1% and mean CGM glucose < or equal to 154 mg/dl [ Time Frame: Days 3-14 ]
    Number of subjects who have less than 1% percent of CGM glucose values < 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl

  7. Number of subjects with time in range (70-180 mg/dl) of 70% or greater [ Time Frame: Days 3-14 ]
    Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Age >/= 10 years and have had a diagnosis of CFRD managed using either an insulin pump or multiple daily injections (MDI).
  • Mean CGM glucose >/=125 mg/dl as determined by the participant's personal CGM 30-day download if CGM is used as part of their usual care. If the participant does not use CGM, hemoglobin A1c >/= 6% within the last 6-months from available medical records will be required.
  • Minimum insulin requirement of >/=0.1u/kg/day. To ensure that participants with a wide range of insulin requirements are included, participants whose insulin requirement is <0.3u/kg/day will be limited to approximately 1/3 of the enrolled >/=18 year old adult cohort.
  • Willing to wear iLet infusion sets and one Dexcom CGM sensor and change sets at least every other day in the iLet arm
  • Assent will be obtained for patients <18 of age

Exclusion criteria

  • Diabetes from etiologies other than CFRD
  • 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 clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
  • Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the next 3-months, or sexually active without use of contraception

    o Participants must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.

  • History of hypoglycemic seizures (grand-mal) or coma in the last year
  • 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 avoid hydroxyurea for duration of study (interferes with accuracy of Dexcom G6 CGM)
  • Unable to avoid taking higher than the maximum dose of acetaminophen from all sources for the duration of the study (interferes with accuracy of Dexcom G6 CGM)

    • Adult: 1 g every 6 hours, up to 4 g every 24 hours
    • Pediatric: 75 mg/kg/day in up to 5 doses, not to exceed 4000 mg/day
  • Have started or stopped a CFTR modulator in the past 4 weeks.
  • 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
  • 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
  • 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.
  • Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study
  • History of severe liver disease, including cirrhosis or portal hypertension
  • Presence of a medical condition or use of a medication that, in the judgment of the investigator, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:

    • 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 participant 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)
    • Renal failure requiring dialysis
    • 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 (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea) oHistory of TIA or stroke
    • Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
    • History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment

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

Locations
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United States, Massachusetts
Massachusetts General Hospital
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
Beta Bionics, Inc.
Investigators
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Principal Investigator: Steven J Russell, MD, PhD Massachusetts General Hospital
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Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03258853    
Other Study ID Numbers: 2020P003452
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De identified glucose data and microbiome data will be shared with research collaborators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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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:
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Cystic Fibrosis
Diabetes Mellitus
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
Pancrelipase
Gastrointestinal Agents