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

  • End date
    Dec 26, 2023
  • participants needed
  • sponsor
    Massachusetts General Hospital
Updated on 15 February 2022


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 Cystic Fibrosis-related Diabetes
Treatment Usual Care, Bionic Pancreas
Clinical Study IdentifierNCT03258853
SponsorMassachusetts General Hospital
Last Modified on15 February 2022


Yes No Not Sure

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
Participants must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study
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
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
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)
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
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
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
Congestive heart failure (established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea) oHistory of TIA or stroke
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
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
Any factors that, in the opinion of the principal investigator would interfere with the safe completion of the study
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
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