Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Re⦠(NCT03258853) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
United States22 participantsStarted 2021-08-26
Plain-language 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.
Who can participate
Age range10 Years
SexALL
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Inclusion criteria
* Age \>/= 10 years and have had a diagnosis of cystic fibrosis related diabetes (CFRD) managed using either an insulin pump or multiple daily injections (MDI).
* Mean continuous glucose monitoring (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)ā¦
What they're measuring
1
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14