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| Name | Class |
|---|---|
| Boston University | OTHER |
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This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes.
Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bionic Pancreas | Experimental | Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days. |
|
| Usual Care | Active Comparator | Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bionic Pancreas | Device |
| ||
| Insulin pump with or without CGM |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 | Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged. | Days 2 to 11 of each period |
| Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated. | Days 2 to 11 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CGMG Values | Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged. | Day 1 and Days 1 to 11 in each period |
| Percentage of Time With CGMG Concentration by Ranges During Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM | 11 days | |
| Number of Unscheduled Infusion Set Replacements | 11 days | |
| Mean Daily Basal Insulin Dose |
Inclusion Criteria:
Exclusion Criteria:
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 diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject
Pregnancy [positive urine human chorionic gonadotropin (HCG)] breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
Need to go outside of the designated geographic boundaries during either arm of the study
Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, 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 or use of marijuana 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 subject 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)
History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.
Renal failure on dialysis
Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes
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)
Abnormal electrocardiogram (EKG) consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal left anterior descending coronary artery (LAD) critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.
Congestive heart failure (CHF) [established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea]
History of transient ischaemic attack (TIA) or stroke
Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants
History of hypoglycemic seizures or coma in the last year
History of pheochromocytoma: fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:
History of adrenal disease or tumor
Hypertension with systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 despite treatment
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.
Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio-frequency (RF) interference
Unable to completely avoid acetaminophen for duration of study
History of adverse reaction to glucagon (including allergy) besides nausea and vomiting
Established history of allergy or severe reaction to adhesive or tape that must be used in the study
History of eating disorder 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 oral [e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter 2 (SGLT-2) inhibitors] anti-diabetic medications
Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)
Any factors that, in the opinion of the site principal investigator or overall principal investigator, would interfere with the safe completion of the study
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Massachusetts General Hospital (MGH) Diabetes Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28007348 | Result | El-Khatib FH, Balliro C, Hillard MA, Magyar KL, Ekhlaspour L, Sinha M, Mondesir D, Esmaeili A, Hartigan C, Thompson MJ, Malkani S, Lock JP, Harlan DM, Clinton P, Frank E, Wilson DM, DeSalvo D, Norlander L, Ly T, Buckingham BA, Diner J, Dezube M, Young LA, Goley A, Kirkman MS, Buse JB, Zheng H, Selagamsetty RR, Damiano ER, Russell SJ. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017 Jan 28;389(10067):369-380. doi: 10.1016/S0140-6736(16)32567-3. Epub 2016 Dec 20. |
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48 participants were enrolled in the trial, but only 43 participants actually participated. 2 participants were not eligible and 3 participants were not randomized because target enrollment was already met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bionic Pancreas Then Usual Care | Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 1 followed by Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 2. There was a 3 to 10-day washout period between periods. |
| FG001 | Usual Care Then Bionic Pancreas | Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 1 followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 2. There was a 3 to 10-day washout period between periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants who completed both periods of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 | Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged. | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | milligrams/deciliter (mg/dL) | Days 2 to 11 of each period |
|
Days 1 to 11
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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 | Bionic Pancreas | Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Steven J Russell | Massachusetts General Hospital | 617-726-1848 | sjrussell@partners.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:
< 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
| Day 1 of each period |
| Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L) | Days 1 to 11 of each period |
| Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L) | Days 2 to 11 of each period |
| Percentage of Participants With Mean CGMG < 154 mg/dl | Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%. | Day 1, Days 2 to11, Days 1 to11 of each period |
| Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL. | Days 1-11 |
| Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care | The percentage of days that participants reported the CGM device was being worn and working properly is reported. | Days 1-11 of each period |
| Glycated Albumin on Day 12 | Day 12 of each period |
| 1,5-anhydroglucitol on Day 12 | Day 12 of each period |
| Anti-Insulin and Anti-Glucagon Antibodies on Day 12 | Day 12 of each period |
| Number of Participants With Severe Hypoglycemic Events | A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person. | 11 days of each period |
| Number of Episodes of Symptomatic Hypoglycemia | The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated. | Day 1, Days 1 to 11 and Days 2 to 11 of each period |
| Number of Reported Carbohydrate Interventions for Hypoglycemia | The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported. | Day 1, Days 1 to 11 and Days 2 to 11 of each period |
| Total Grams of Carbohydrate Taken for Hypoglycemia | The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged. The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported. | Day 1, Days 1 to 11 and Days 2 to 11 of each period |
| Insulin Total Daily Dose | Insulin total daily dose is reported in units per kilogram per day (U/kg/day). | Day 1, Days 1 to 11, Days 2 to 11 of each period |
| Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day). | Day 1, Days 2 to 11, Days 1 to 11 of each period |
| Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period |
| Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly | Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction. | 11 days |
| Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated. | Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period |
| Change From Baseline in Body Weight | The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight. | Baseline and Day 12 of each period |
| Change From Baseline in Hemoglobin | The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin. | Baseline and Day 12 of each period |
| Number of Participants With Skin Rash | 11 days of each period |
Daily basal insulin dose reported in Units per kilogram per day (U/kg/day). |
| Day 1, Days 2 to 11, each individual day 2 to 11 of each period |
| Mean Daily Bolus Insulin Dose | Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day). | Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period |
| CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads | This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM. | 11 days |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| UMass Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| NOT COMPLETED |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
|
| Primary | Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated. | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | percentage of time | Days 2 to 11 of each period |
|
|
|
|
| Secondary | Mean CGMG Values | Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged. | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | mg/dL | Day 1 and Days 1 to 11 in each period |
|
|
|
| Secondary | Percentage of Time With CGMG Concentration by Ranges During Day 1 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L) | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | percentage of time | Day 1 of each period |
|
|
|
| Secondary | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L) | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | percentage of time | Days 1 to 11 of each period |
|
|
|
| Secondary | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L) | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | percentage of time | Days 2 to 11 of each period |
|
|
|
| Secondary | Percentage of Participants With Mean CGMG < 154 mg/dl | Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%. | All randomized participants who completed both periods of the study. | Posted | Number | percentage of participants | Day 1, Days 2 to11, Days 1 to11 of each period |
|
|
|
| Secondary | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL. | Posted | Mean | Standard Deviation | hypoglycemic events | Days 1-11 |
|
|
|
| Secondary | Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care | The percentage of days that participants reported the CGM device was being worn and working properly is reported. | All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm. | Posted | Number | percentage of days | Days 1-11 of each period |
|
|
|
| Secondary | Glycated Albumin on Day 12 | No data was collected for Glycated Albumin. | Posted | Day 12 of each period |
|
|
| Secondary | 1,5-anhydroglucitol on Day 12 | No data was collected for 1,5-anhydroglucitol. | Posted | Day 12 of each period |
|
|
| Secondary | Anti-Insulin and Anti-Glucagon Antibodies on Day 12 | No data was collected for Anti-Insulin and Anti-Glucagon Antibodies. | Posted | Day 12 of each period |
|
|
| Secondary | Number of Participants With Severe Hypoglycemic Events | A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person. | All participants who completed both periods of the study. | Posted | Count of Participants | Participants | 11 days of each period |
|
|
|
| Secondary | Number of Episodes of Symptomatic Hypoglycemia | The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated. | All participants who completed both periods of the study. | Posted | Mean | Standard Deviation | episodes per day | Day 1, Days 1 to 11 and Days 2 to 11 of each period |
|
|
|
| Secondary | Number of Reported Carbohydrate Interventions for Hypoglycemia | The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported. | All participants who completed both periods of the study. | Posted | Mean | Standard Deviation | interventions per day | Day 1, Days 1 to 11 and Days 2 to 11 of each period |
|
|
|
| Secondary | Total Grams of Carbohydrate Taken for Hypoglycemia | The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged. The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported. | All participants who completed both periods of the study. | Posted | Mean | Standard Deviation | grams of carbohydrate per day | Day 1, Days 1 to 11 and Days 2 to 11 of each period |
|
|
|
| Secondary | Insulin Total Daily Dose | Insulin total daily dose is reported in units per kilogram per day (U/kg/day). | All participants who completed both periods of the study. | Posted | Mean | Standard Deviation | U/kg/day | Day 1, Days 1 to 11, Days 2 to 11 of each period |
|
|
|
| Secondary | Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day). | All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only. | Posted | Mean | Standard Deviation | µg/kg/day | Day 1, Days 2 to 11, Days 1 to 11 of each period |
|
|
|
| Secondary | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | mg/dL | Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period |
|
|
|
| Secondary | Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly | Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction. | All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only | Posted | Mean | Standard Deviation | percentage of time | 11 days |
|
|
|
| Secondary | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated. | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | cm | Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period |
|
|
|
| Secondary | Change From Baseline in Body Weight | The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight. | All participants who completed both periods of the study. | Posted | Mean | Standard Deviation | kilograms | Baseline and Day 12 of each period |
|
|
|
| Secondary | Change From Baseline in Hemoglobin | The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin. | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | grams/deciliter (mg/dL) | Baseline and Day 12 of each period |
|
|
|
| Secondary | Number of Participants With Skin Rash | All randomized participants who completed both periods of the study. | Posted | Count of Participants | Participants | 11 days of each period |
|
|
|
| Other Pre-specified | Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM | All randomized participants who completed both periods. | Posted | Mean | Standard Deviation | percentage of possible values | 11 days |
|
|
|
| Other Pre-specified | Number of Unscheduled Infusion Set Replacements | All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm. | Posted | Number | Infusion Set Relacements | 11 days |
|
|
|
| Other Pre-specified | Mean Daily Basal Insulin Dose | Daily basal insulin dose reported in Units per kilogram per day (U/kg/day). | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | U/kg/day | Day 1, Days 2 to 11, each individual day 2 to 11 of each period |
|
|
|
| Other Pre-specified | Mean Daily Bolus Insulin Dose | Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day). | All randomized participants who completed both periods of the study. | Posted | Mean | Standard Deviation | U/kg/day | Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period |
|
|
|
| Other Pre-specified | CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads | This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM. | All randomized participants who completed both periods. | Posted | Mean | Standard Deviation | percent difference | 11 days |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 41 |
| 41 |
| EG001 | Usual Care | Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days. | 0 | 41 | 0 | 41 | 41 | 41 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| < 70 mg/dl (3.9 mmol/L) |
|
| 70 to 120 mg/dL (3.9 to 6.7 mmol/L) |
|
| 70-180 mg/dl (3.9 to 10.0 mmol/L) |
|
| > 180 mg/dL (10.0 mmol/L) |
|
| > 250 mg/dL (13.9 mmol/L) |
|
| < 70 mg/dl (3.9 mmol/L) |
|
| 70 to 120 mg/dL (3.9 to 6.7 mmol/L) |
|
| 70-180 mg/dl (3.9 to 10.0 mmol/L) |
|
| > 180 mg/dL (10.0 mmol/L) |
|
| > 250 mg/dL (13.9 mmol/L) |
|
| 70 to 120 mg/dL (3.9 to 6.7 mmol/L) |
|
| 70-180 mg/dl (3.9 to 10.0 mmol/L) |
|
| > 180 mg/dL (10.0 mmol/L) |
|
| > 250 mg/dL (13.9 mmol/L) |
|
| Days 2 to 11 |
|
| <70 mg/dl |
|
| Days 2 to 11 |
|
| Days 2 to 11 |
|
| Days 2 to 11 |
|
| Days 2 to 11 |
|
| Title | Measurements |
|---|---|
|
|
| Day 2 to 11, Overall |
|
| Day 2 to 11, Daytime |
|
| Day 2 to 11, Nighttime |
|
| Day 1 to 11, Overall |
|
| Day 1 to 11, Daytime |
|
| Day 1 to 11, Nighttime |
|
|
| Days 2 to 11 |
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|
| Insulin Unscheduled Infusion Set Replacements |
|
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|
| Days 2 to 11 |
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Day 11 |
|