N/A
N=22
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
Cystic Fibrosis-related Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03258853 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14 — 63; 75 percentage of time spent in target range — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bionic Pancreas (Device); Usual Care (Other)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14 |
63; 75 | 0.001 sig |
| SECONDARY Percentage of Time Spent With CGM Glucose: < 54 mg/dl |
0.36; 0.27 | 1.0 |
| SECONDARY Mean CGM Glucose |
171; 150 | 0.04 sig |
| SECONDARY Percentage of Time Spent With CGM Glucose < 70 mg/dl |
1.5; 1.7 | 1.0 |
| SECONDARY Percentage of Time Spent With CGM Glucose >180 mg/dL |
31; 18 | 0.014 sig |
| SECONDARY Percentage of Time Spent With CGM Glucose > 250mg/dL |
10; 3.9 | 0.014 sig |
| SECONDARY Standard Deviation |
60; 54 | 0.14 |
| SECONDARY Coefficient of Variation |
35; 35 | 1.0 |
| SECONDARY Number of Episodes of Self-reported Symptomatic Hypoglycemia |
0.4; 0.7 | 0.01 sig |
| SECONDARY Number of Subjects With Mean CGMG <154 mg/dl |
9; 12 | 0.08 |
| SECONDARY Number of Subjects With Percentage of Time < 54 mg/dl < 1% |
17; 16 | 0.56 |
| SECONDARY Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl |
7; 8 | 0.56 |
| SECONDARY Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater |
9; 11 | 0.15 |
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.
Eligibility Criteria
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 /=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 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
Data sourced from ClinicalTrials.gov (NCT03258853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.