Cystic Fibrosis-related DiabetesNCT03258853
Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes
A study testing Bionic Pancreas in people with Cystic Fibrosis-related Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis-related Diabetes
- What is being tested?
- Bionic Pancreas
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 29 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 30Show fewer
- 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 cystic fibrosis transmembrane conductance regulator (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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Feasibility of Outpatient Automated Blood Glucose Control With the iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes
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.
- Conditions
- Cystic Fibrosis-related Diabetes
- Being tested
- Bionic Pancreas, Usual Care
- Keywords
- cystic fibrosis, insulin, glucagon, continuous glucose monitor, bionic pancreas
- Medical subject headings
- Cystic Fibrosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionic PancreasDevice
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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 Receives: Other: Usual Care |
| Insulin only bionic pancreas | Experimental | 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. Receives: Device: Bionic Pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
Measured: Days 3-14
Secondary outcomes (12)
Percentage of Time Spent With CGM Glucose: < 54 mg/dl
Percentage of time spent with CGM glucose in this range
Measured: Days 3-14
Mean CGM Glucose
Average CGM glucose
Measured: Days 3-14
Percentage of Time Spent With CGM Glucose < 70 mg/dl
Percent of time the participant spent with CGM glucose in this range
Measured: Days 3-14
Percentage of Time Spent With CGM Glucose >180 mg/dL
The percent of time the participant spent with CGM glucose in this range
Measured: Days 3-14
Percentage of Time Spent With CGM Glucose > 250mg/dL
The percent of time the participant spent with CGM glucose in this range
Measured: Days 3-14
Standard Deviation
Standard deviation of participants' mean CGM glucose
Measured: Days 3-14
Coefficient of Variation
Coefficient of variation of CGM glucose values
Measured: Days 3-14
Number of Episodes of Self-reported Symptomatic Hypoglycemia
Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)
Measured: Days 3-14
Number of Subjects With Mean CGMG <154 mg/dl
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)
Measured: Days 3-14
Number of Subjects With Percentage of Time < 54 mg/dl < 1%
Number of subjects who have less than 1% percent of CGM glucose values < 54 mg/dl
Measured: Days 3-14
Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl
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
Measured: Days 3-14
Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater
Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl
Measured: Days 3-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start26 Aug 2021
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beta Bionics, Inc.
- Responsible party
- Principal investigator, Melissa Susan Putman, Massachusetts General Hospital
- Investigators
- Melissa S Putman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258853
- Sponsor's protocol ID
- 2020P003452
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2017
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De identified glucose data and microbiome data will be shared with research collaborators.
Publications
Sherwood JS, Castellanos LE, O'Connor MY, Balliro CA, Hillard MA, Gaston SG, Bartholomew R, Greaux E, Sabean A, Zheng H, Marchetti P, Uluer A, Sawicki GS, Neuringer I, El-Khatib FH, Damiano ER, Russell SJ, Putman MS. Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes. Diabetes Care. 2024 Jan 1;47(1):101-108. doi: 10.2337/dc23-1411.
PubMed 37874987
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Outpatient Automated Blood Glucose Control With the iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes
- ClinicalTrials.gov ID
- NCT03258853
- Acronym / sponsor ID
- 2020P003452
- Conditions
- Cystic Fibrosis-related Diabetes
- Keywords
- cystic fibrosis, insulin, glucagon, continuous glucose monitor, bionic pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beta Bionics, Inc.
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 20 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareUsual 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 |
| Insulin only bionic pancreas | Experimental | Device: Bionic PancreasInsulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bionic PancreasBionic 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. | Device | Insulin only bionic pancreas |
| Usual CareSubjects 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. | Other | Usual Care |
Primary outcome
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
Time frame: Days 3-14
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
12 secondary outcomes
Percentage of Time Spent With CGM Glucose: < 54 mg/dl
Time frame: Days 3-14
Mean CGM Glucose
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose < 70 mg/dl
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose >180 mg/dL
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose > 250mg/dL
Time frame: Days 3-14
Standard Deviation
Time frame: Days 3-14
Coefficient of Variation
Time frame: Days 3-14
Number of Episodes of Self-reported Symptomatic Hypoglycemia
Time frame: Days 3-14
Number of Subjects With Mean CGMG <154 mg/dl
Time frame: Days 3-14
Number of Subjects With Percentage of Time < 54 mg/dl < 1%
Time frame: Days 3-14
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 With Time in Range (70-180 mg/dl) of 70% or Greater
Time frame: Days 3-14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37874987Sherwood JS, Castellanos LE, O'Connor MY, Balliro CA, Hillard MA, Gaston SG, Bartholomew R, Greaux E, Sabean A, Zheng H, Marchetti P, Uluer A, Sawicki GS, Neuringer I, El-Khatib FH, Damiano ER, Russell SJ, Putman MS. Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes. Diabetes Care. 2024 Jan 1;47(1):101-108. doi: 10.2337/dc23-1411.
- Individual participant dataSharing planned: Yes. De identified glucose data and microbiome data will be shared with research collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa S Putman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionic Pancreas in people with Cystic Fibrosis-related Diabetes, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14 (time frame: Days 3-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.