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| Name | Class |
|---|---|
| Beta Bionics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bionic Pancreas | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Days 3-14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent With CGM Glucose: < 54 mg/dl | Percentage of time spent with CGM glucose in this range | Days 3-14 |
| Mean CGM Glucose | Average CGM glucose |
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Inclusion criteria
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)
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:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa S Putman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37874987 | Derived | 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. |
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De identified glucose data and microbiome data will be shared with research collaborators.
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30 adults were consented and screened for study participation. Of these, 3 did not meet inclusion criteria, 3 declined to participate, and 2 were lost to follow-up prior to randomization. The remaining 22 subjects were randomized. 2 subjects were assigned to a study arm but withdrew prior to any study procedures. No baseline or outcome data were collected in these 2 subjects, and they were excluded from all analyses. The remaining 20 subjects completed the study and are included in the analyses.
Recruitment occurred between April 2021 and June 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care First, Then Insulin Only Bionic Pancreas | 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 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. After completing 14 days of Usual Care, participants then crossed over to the insulin only bionic pancreas for another 14 days. 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. 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. |
| FG001 | Insulin Only Bionic Pancreas First, Then Usual Care | 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. 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. After completing 14 days of the insulin only bionic pancreas, participants then crossed over to Usual Care for another 14 days: 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
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| ||||||||||||||||||
| Second Intervention (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care First, Then Insulin Only Bionic Pancreas | 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 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. After 14 days of Usual Care, participants then crossed over to the Insulin only bionic pancreas arm for anther 14 days. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This was a random-order cross-over design clinical trial. Each participant completed each study arm. | Posted | Mean | Standard Deviation | percentage of time spent in target range | Days 3-14 |
|
Adverse event data were collected after screening and enrollment until the participant completed both arms of the trial, each 14 days in duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia without ketosis | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Putman | Massachusetts General Hospital | 617-726-1847 | msputman@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2022 | May 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 28, 2022 | May 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| Usual Care | Other | 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. |
|
| 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 | 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 | 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 | Days 3-14 |
| Standard Deviation | Standard deviation of participants' mean CGM glucose | Days 3-14 |
| Coefficient of Variation | Coefficient of variation of CGM glucose values | Days 3-14 |
| Number of Episodes of Self-reported Symptomatic Hypoglycemia | Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia) | 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) | 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 | 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 | 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 | Days 3-14 |
| NOT COMPLETED |
|
| BG001 | Insulin Only Bionic Pancreas First, Then Usual Care | 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. 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. After 14 days of the insulin only bionic pancreas, participants then crossed over to the usual care arm for another 14 days. 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| HbA1c | Mean | Standard Deviation | % of glycated hemoglobin |
|
| Mean CGM glucose | Mean | Standard Deviation | mg/dL |
|
| Cystic fibrosis related diabetes (CFRD) duration | Mean | Standard Deviation | years |
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| Insulin Total Daily Dose | Mean | Standard Deviation | units/kg/day |
|
| Percent predicted forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | % of predicted |
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| Pancreatic insufficiency | Count of Participants | Participants |
|
| Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Use | Count of Participants | Participants |
|
| Continuous glucose monitor (CGM) Use | Count of Participants | Participants |
|
| Multiple Daily Injection Use | Count of Participants | Participants |
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| Insulin Pump Use | Count of Participants | Participants |
|
| OG001 | 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. 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. |
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| Secondary | Percentage of Time Spent With CGM Glucose: < 54 mg/dl | Percentage of time spent with CGM glucose in this range | Posted | Median | Inter-Quartile Range | percentage of time spent <54mg/dL | Days 3-14 |
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| Secondary | Mean CGM Glucose | Average CGM glucose | Posted | Mean | Standard Deviation | mg/dL | Days 3-14 |
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| Secondary | Percentage of Time Spent With CGM Glucose < 70 mg/dl | Percent of time the participant spent with CGM glucose in this range | Posted | Median | Inter-Quartile Range | percentage of time | Days 3-14 |
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| Secondary | Percentage of Time Spent With CGM Glucose >180 mg/dL | The percent of time the participant spent with CGM glucose in this range | Posted | Median | Inter-Quartile Range | percentage of time | Days 3-14 |
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| Secondary | Percentage of Time Spent With CGM Glucose > 250mg/dL | The percent of time the participant spent with CGM glucose in this range | Posted | Median | Inter-Quartile Range | percentage of time | Days 3-14 |
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| Secondary | Standard Deviation | Standard deviation of participants' mean CGM glucose | Posted | Mean | Standard Deviation | mg/dL | Days 3-14 |
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| Secondary | Coefficient of Variation | Coefficient of variation of CGM glucose values | Posted | Mean | Standard Deviation | percentage of variability | Days 3-14 |
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| Secondary | Number of Episodes of Self-reported Symptomatic Hypoglycemia | Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia) | Posted | Median | Inter-Quartile Range | Episodes | Days 3-14 |
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| Secondary | 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) | Posted | Count of Participants | Participants | Days 3-14 |
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| Secondary | 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 | Posted | Count of Participants | Participants | Days 3-14 |
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| Secondary | 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 | Posted | Count of Participants | Participants | Days 3-14 |
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| Secondary | 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 | Posted | Count of Participants | Participants | Days 3-14 |
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| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | 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. 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. | 0 | 20 | 0 | 20 | 6 | 20 |
| Hyperglycemia with ketosis | Endocrine disorders | Systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Hypoglycemia unawareness | Endocrine disorders | Systematic Assessment |
|
| Pulmonary exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |