Diabetes Mellitus Type 1
Conditions
Keywords
Bionic Pancreas, Insulin, Glucagon, Continuous Glucose Monitor
Brief summary
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.
Interventions
DEVICEBionic Pancreas
DEVICEInsulin pump with or without CGM
Sponsors
Boston University
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years and have had clinical type 1 diabetes for at least one year * Diabetes managed using an insulin pump for ≥ 6 months * Prescription medication regimen stable for \> 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgement of the site principal investigator). * Employee or student working or studying during most of the week at one of the participating 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) * Lives within a 30 minute drive-time radius of the central monitoring location for one of the study sites * Willing to remain within a 60 minute drive-time radius of the central monitoring location for one of the study sites during each of the 11-day study arms * Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time) * Willing to wear two infusion sets and continuous glucose monitor (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)
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: * episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension * paroxysms of tachycardia, pallor, or headache * personal or family history of multiple endocrine neoplasia type 2A (MEN 2A), multiple endocrine neoplasia type 2B (MEN 2B), neurofibromatosis, or von Hippel-Lindau disease * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 | Days 2 to 11 of each period | Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged. |
| Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11 | Days 2 to 11 of each period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Insulin and Anti-Glucagon Antibodies on Day 12 | Day 12 of each period | — |
| Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly | 11 days | 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. |
| Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period | 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. |
| Change From Baseline in Body Weight | Baseline and Day 12 of each period | 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. |
| Change From Baseline in Hemoglobin | Baseline and Day 12 of each period | 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. |
| Number of Participants With Skin Rash | 11 days of each period | — |
| Mean CGMG Values | Day 1 and Days 1 to 11 in each period | Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged. |
| Percentage of Time With CGMG Concentration by Ranges During Day 1 | Day 1 of each period | 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) |
| Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | Days 1 to 11 of each period | 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) |
| Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | Days 2 to 11 of each period | 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) |
| Percentage of Participants With Mean CGMG < 154 mg/dl | Day 1, Days 2 to11, Days 1 to11 of each period | 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%. |
| Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | Days 1-11 | 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. |
| Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care | Days 1-11 of each period | The percentage of days that participants reported the CGM device was being worn and working properly is reported. |
| Glycated Albumin on Day 12 | Day 12 of each period | — |
| 1,5-anhydroglucitol on Day 12 | Day 12 of each period | — |
| Number of Participants With Severe Hypoglycemic Events | 11 days of each period | A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person. |
| Number of Episodes of Symptomatic Hypoglycemia | Day 1, Days 1 to 11 and Days 2 to 11 of each period | 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. |
| Number of Reported Carbohydrate Interventions for Hypoglycemia | Day 1, Days 1 to 11 and Days 2 to 11 of each period | The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported. |
| Total Grams of Carbohydrate Taken for Hypoglycemia | Day 1, Days 1 to 11 and Days 2 to 11 of each period | 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. |
| Insulin Total Daily Dose | Day 1, Days 1 to 11, Days 2 to 11 of each period | Insulin total daily dose is reported in units per kilogram per day (U/kg/day). |
| Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Day 1, Days 2 to 11, Days 1 to 11 of each period | Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day). |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Daily Bolus Insulin Dose | Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period | Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day). |
| CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads | 11 days | 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. |
| Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM | 11 days | — |
| Mean Daily Basal Insulin Dose | Day 1, Days 2 to 11, each individual day 2 to 11 of each period | Daily basal insulin dose reported in Units per kilogram per day (U/kg/day). |
| Number of Unscheduled Infusion Set Replacements | 11 days | — |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants who completed both periods of the study. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Unrelated Illness | 0 | 2 |
| Period 2 | Nausea, Anxiety, Inconvenience | 0 | 1 |
| Period 2 | Severe Hypoglycaemia | 1 | 0 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 33.3 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 41 / 41 | 41 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
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.
Time frame: Days 2 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 | 141.2 milligrams/deciliter (mg/dL) | Standard Deviation 9.9 |
| Usual Care | Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 | 161.5 milligrams/deciliter (mg/dL) | Standard Deviation 28.7 |
p-value: <0.000195% CI: [-28, -12.56]t-test, 2 sided
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.
Time frame: Days 2 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11 | 0.6 percentage of time | Standard Deviation 0.6 |
| Usual Care | Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11 | 1.9 percentage of time | Standard Deviation 1.7 |
p-value: <0.000195% CI: [0.8, 1.8]t-test, 2 sided
Secondary
1,5-anhydroglucitol on Day 12
Time frame: Day 12 of each period
Population: No data was collected for 1,5-anhydroglucitol.
Secondary
Anti-Insulin and Anti-Glucagon Antibodies on Day 12
Time frame: Day 12 of each period
Population: No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.
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.
Time frame: Baseline and Day 12 of each period
Population: All participants who completed both periods of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Change From Baseline in Body Weight | 0.4 kilograms | Standard Deviation 0.95 |
| Usual Care | Change From Baseline in Body Weight | 0.1 kilograms | Standard Deviation 1.1 |
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.
Time frame: Baseline and Day 12 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Change From Baseline in Hemoglobin | -0.16 grams/deciliter (mg/dL) | Standard Deviation 0.68 |
| Usual Care | Change From Baseline in Hemoglobin | 0.14 grams/deciliter (mg/dL) | Standard Deviation 0.68 |
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).
Time frame: Day 1, Days 2 to 11, Days 1 to 11 of each period
Population: All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Day 1 | 7.8 µg/kg/day | Standard Deviation 3.84 |
| Bionic Pancreas | Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Days 1 to 11 | 6.9 µg/kg/day | Standard Deviation 2.34 |
| Bionic Pancreas | Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Days 2 to 11 | 6.8 µg/kg/day | Standard Deviation 2.4 |
Secondary
Glycated Albumin on Day 12
Time frame: Day 12 of each period
Population: No data was collected for Glycated Albumin.
Secondary
Insulin Total Daily Dose
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time frame: Day 1, Days 1 to 11, Days 2 to 11 of each period
Population: All participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Insulin Total Daily Dose | Day 1 | 0.64 U/kg/day | Standard Deviation 0.2 |
| Bionic Pancreas | Insulin Total Daily Dose | Days 1 to 11 | 0.66 U/kg/day | Standard Deviation 0.15 |
| Bionic Pancreas | Insulin Total Daily Dose | Days 2 to 11 | 0.66 U/kg/day | Standard Deviation 0.15 |
| Usual Care | Insulin Total Daily Dose | Day 1 | 0.64 U/kg/day | Standard Deviation 0.21 |
| Usual Care | Insulin Total Daily Dose | Days 1 to 11 | 0.63 U/kg/day | Standard Deviation 0.18 |
| Usual Care | Insulin Total Daily Dose | Days 2 to 11 | 0.62 U/kg/day | Standard Deviation 0.18 |
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.
Time frame: Day 1 and Days 1 to 11 in each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Mean CGMG Values | Day 1 | 145.3 mg/dL | Standard Deviation 17.6 |
| Bionic Pancreas | Mean CGMG Values | Days 1 to 11 | 141.5 mg/dL | Standard Deviation 10 |
| Usual Care | Mean CGMG Values | Day 1 | 161.9 mg/dL | Standard Deviation 45.2 |
| Usual Care | Mean CGMG Values | Days 1 to 11 | 161.7 mg/dL | Standard Deviation 29.3 |
Secondary
Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Time frame: Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1, Overall | 101.2 mg/dL | Standard Deviation 2 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1, Daytime | 101.3 mg/dL | Standard Deviation 1.6 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1, Nighttime | 101.0 mg/dL | Standard Deviation 3.9 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 2 to 11, Overall | 101.9 mg/dL | Standard Deviation 5 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 2 to 11, Daytime | 102.0 mg/dL | Standard Deviation 5.1 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 2 to 11, Nighttime | 101.7 mg/dL | Standard Deviation 4.9 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1 to 11, Overall | 101.8 mg/dL | Standard Deviation 4.6 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1 to 11, Daytime | 101.9 mg/dL | Standard Deviation 4.7 |
| Bionic Pancreas | Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm | Day 1 to 11, Nighttime | 101.6 mg/dL | Standard Deviation 4.5 |
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.
Time frame: Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Days 2 to 11 | 0.48 cm | Standard Deviation 0.82 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 5 | 0.33 cm | Standard Deviation 1.11 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 8 | 0.67 cm | Standard Deviation 1.49 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 6 | 0.56 cm | Standard Deviation 1.25 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 2 | 0.46 cm | Standard Deviation 1.55 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 7 | 0.49 cm | Standard Deviation 1.47 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Days 1 to 11 | 0.51 cm | Standard Deviation 0.79 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 3 | 0.56 cm | Standard Deviation 1.47 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 9 | 0.44 cm | Standard Deviation 1.23 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 10 | 0.59 cm | Standard Deviation 1.62 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 1 | 0.79 cm | Standard Deviation 1.54 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 11 | 0.28 cm | Standard Deviation 1.45 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 4 | 0.41 cm | Standard Deviation 1.19 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 11 | 0.03 cm | Standard Deviation 0.16 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 1 | 0.00 cm | Standard Deviation 0 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Days 1 to 11 | 0.05 cm | Standard Deviation 0.17 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Days 2 to 11 | 0.05 cm | Standard Deviation 0.18 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 2 | 0.08 cm | Standard Deviation 0.48 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 3 | 0.03 cm | Standard Deviation 0.16 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 4 | 0.13 cm | Standard Deviation 0.47 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 5 | 0.00 cm | Standard Deviation 0 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 6 | 0.00 cm | Standard Deviation 0 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 7 | 0.03 cm | Standard Deviation 0.16 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 8 | 0.08 cm | Standard Deviation 0.35 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 10 | 0.08 cm | Standard Deviation 0.35 |
| Usual Care | Mean Nausea Index Score Using a Visual Analog Scale (VAS) | Day 9 | 0.10 cm | Standard Deviation 0.5 |
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.
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Population: All participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Number of Episodes of Symptomatic Hypoglycemia | Day 1 | 0.74 episodes per day | Standard Deviation 1.04 |
| Bionic Pancreas | Number of Episodes of Symptomatic Hypoglycemia | Days 1 to 11 | 0.59 episodes per day | Standard Deviation 0.56 |
| Bionic Pancreas | Number of Episodes of Symptomatic Hypoglycemia | Days 2 to 11 | 0.57 episodes per day | Standard Deviation 0.54 |
| Usual Care | Number of Episodes of Symptomatic Hypoglycemia | Day 1 | 1.13 episodes per day | Standard Deviation 1.12 |
| Usual Care | Number of Episodes of Symptomatic Hypoglycemia | Days 1 to 11 | 0.90 episodes per day | Standard Deviation 0.64 |
| Usual Care | Number of Episodes of Symptomatic Hypoglycemia | Days 2 to 11 | 0.88 episodes per day | Standard Deviation 0.64 |
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.
Time frame: Days 1-11
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <50 mg/dl | 0.58 hypoglycemic events | Standard Deviation 0.87 |
| Bionic Pancreas | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <60 mg/dl | 1.33 hypoglycemic events | Standard Deviation 1.31 |
| Bionic Pancreas | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <70 mg/dl | 2.68 hypoglycemic events | Standard Deviation 2.4 |
| Usual Care | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <50 mg/dl | 1.0 hypoglycemic events | Standard Deviation 1.06 |
| Usual Care | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <60 mg/dl | 2.88 hypoglycemic events | Standard Deviation 2.67 |
| Usual Care | Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <70 mg/dl | 5.28 hypoglycemic events | Standard Deviation 4.14 |
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.
Time frame: 11 days of each period
Population: All participants who completed both periods of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bionic Pancreas | Number of Participants With Severe Hypoglycemic Events | 0 Participants |
| Usual Care | Number of Participants With Severe Hypoglycemic Events | 1 Participants |
Secondary
Number of Participants With Skin Rash
Time frame: 11 days of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bionic Pancreas | Number of Participants With Skin Rash | 0 Participants |
| Usual Care | Number of Participants With Skin Rash | 0 Participants |
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.
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Population: All participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Number of Reported Carbohydrate Interventions for Hypoglycemia | Day 1 | 0.36 interventions per day | Standard Deviation 0.63 |
| Bionic Pancreas | Number of Reported Carbohydrate Interventions for Hypoglycemia | Days 1 to 11 | 0.39 interventions per day | Standard Deviation 0.34 |
| Bionic Pancreas | Number of Reported Carbohydrate Interventions for Hypoglycemia | Days 2 to 11 | 0.40 interventions per day | Standard Deviation 0.34 |
| Usual Care | Number of Reported Carbohydrate Interventions for Hypoglycemia | Day 1 | 1.29 interventions per day | Standard Deviation 1.25 |
| Usual Care | Number of Reported Carbohydrate Interventions for Hypoglycemia | Days 1 to 11 | 0.96 interventions per day | Standard Deviation 0.72 |
| Usual Care | Number of Reported Carbohydrate Interventions for Hypoglycemia | Days 2 to 11 | 0.93 interventions per day | Standard Deviation 0.72 |
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.
Time frame: Days 1-11 of each period
Population: All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bionic Pancreas | Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care | 49 percentage of days |
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%.
Time frame: Day 1, Days 2 to11, Days 1 to11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Percentage of Participants With Mean CGMG < 154 mg/dl | Day 1 | 79 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG < 154 mg/dl | Days 1 to 11 | 92 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG < 154 mg/dl | Days 2 to 11 | 92 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG < 154 mg/dl | Day 1 | 59 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG < 154 mg/dl | Days 1 to 11 | 41 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG < 154 mg/dl | Days 2 to 11 | 41 percentage of participants |
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.
Time frame: 11 days
Population: All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly | Insulin pump Lost Wireless Connectivity | 3.9 percentage of time | Standard Deviation 2.5 |
| Bionic Pancreas | Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly | Glucagon Pump Lost Wireless Connectivity | 4.1 percentage of time | Standard Deviation 2.4 |
| Bionic Pancreas | Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly | CGM Signal Unavailable | 3.4 percentage of time | Standard Deviation 1.3 |
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)
Time frame: Day 1 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 70 mg/dl (3.9 mmol/L) | 1.5 percentage of time | Standard Deviation 2.3 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 76.8 percentage of time | Standard Deviation 11.5 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 60 mg/dL (3.3 mmol/L) | 0.5 percentage of time | Standard Deviation 0.9 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | > 180 mg/dL (10.0 mmol/L) | 21.7 percentage of time | Standard Deviation 11.2 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | 70 to 120 mg/dL (3.9 to 6.7 mmol/L) | 39.4 percentage of time | Standard Deviation 13.6 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | > 250 mg/dL (13.9 mmol/L) | 6.0 percentage of time | Standard Deviation 7.4 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 50 mg/dl (2.8 mmol/L) | 0.1 percentage of time | Standard Deviation 0.3 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | > 250 mg/dL (13.9 mmol/L) | 12.3 percentage of time | Standard Deviation 17.7 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 50 mg/dl (2.8 mmol/L) | 0.9 percentage of time | Standard Deviation 1.5 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 60 mg/dL (3.3 mmol/L) | 2.3 percentage of time | Standard Deviation 3.4 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 70 mg/dl (3.9 mmol/L) | 5.0 percentage of time | Standard Deviation 6.5 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | 70 to 120 mg/dL (3.9 to 6.7 mmol/L) | 28.5 percentage of time | Standard Deviation 18.6 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 62.1 percentage of time | Standard Deviation 22.2 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | > 180 mg/dL (10.0 mmol/L) | 32.9 percentage of time | Standard Deviation 24 |
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)
Time frame: Days 1 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | < 70 mg/dl (3.9 mmol/L) | 1.8 percentage of time | Standard Deviation 1.4 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 78.3 percentage of time | Standard Deviation 6 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | < 60 mg/dL (3.3 mmol/L) | 0.6 percentage of time | Standard Deviation 0.5 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | > 180 mg/dL (10.0 mmol/L) | 19.9 percentage of time | Standard Deviation 6 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | 70 to 120 mg/dL (3.9 to 6.7 mmol/L) | 40.6 percentage of time | Standard Deviation 8 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | > 250 mg/dL (13.9 mmol/L) | 4.4 percentage of time | Standard Deviation 2.7 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | < 50 mg/dl (2.8 mmol/L) | 0.1 percentage of time | Standard Deviation 0.1 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | > 250 mg/dL (13.9 mmol/L) | 11.0 percentage of time | Standard Deviation 10.3 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | < 50 mg/dl (2.8 mmol/L) | 0.6 percentage of time | Standard Deviation 0.6 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | < 60 mg/dL (3.3 mmol/L) | 1.9 percentage of time | Standard Deviation 1.8 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | < 70 mg/dl (3.9 mmol/L) | 4.6 percentage of time | Standard Deviation 3.9 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | 70 to 120 mg/dL (3.9 to 6.7 mmol/L) | 27.5 percentage of time | Standard Deviation 11.3 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 61.9 percentage of time | Standard Deviation 14.5 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 | > 180 mg/dL (10.0 mmol/L) | 33.5 percentage of time | Standard Deviation 16.5 |
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)
Time frame: Days 2 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | < 50 mg/dl (2.8 mmol/L) | 0.1 percentage of time | Standard Deviation 0.2 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | < 70 mg/dl (3.9 mmol/L) | 1.8 percentage of time | Standard Deviation 1.4 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | 70 to 120 mg/dL (3.9 to 6.7 mmol/L) | 40.7 percentage of time | Standard Deviation 7.8 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 78.4 percentage of time | Standard Deviation 6 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | > 180 mg/dL (10.0 mmol/L) | 19.8 percentage of time | Standard Deviation 6.1 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | > 250 mg/dL (13.9 mmol/L) | 4.2 percentage of time | Standard Deviation 2.7 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | > 180 mg/dL (10.0 mmol/L) | 33.6 percentage of time | Standard Deviation 16.4 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | < 50 mg/dl (2.8 mmol/L) | 0.6 percentage of time | Standard Deviation 0.6 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 61.9 percentage of time | Standard Deviation 14.4 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | < 70 mg/dl (3.9 mmol/L) | 4.5 percentage of time | Standard Deviation 3.8 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | > 250 mg/dL (13.9 mmol/L) | 10.9 percentage of time | Standard Deviation 10 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 | 70 to 120 mg/dL (3.9 to 6.7 mmol/L) | 27.4 percentage of time | Standard Deviation 11.4 |
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.
Time frame: Day 1, Days 1 to 11 and Days 2 to 11 of each period
Population: All participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Total Grams of Carbohydrate Taken for Hypoglycemia | Day 1 | 6.18 grams of carbohydrate per day | Standard Deviation 11.61 |
| Bionic Pancreas | Total Grams of Carbohydrate Taken for Hypoglycemia | Days 1 to 11 | 22.04 grams of carbohydrate per day | Standard Deviation 13.62 |
| Bionic Pancreas | Total Grams of Carbohydrate Taken for Hypoglycemia | Days 2 to 11 | 22.27 grams of carbohydrate per day | Standard Deviation 13.79 |
| Usual Care | Total Grams of Carbohydrate Taken for Hypoglycemia | Day 1 | 25.61 grams of carbohydrate per day | Standard Deviation 26.12 |
| Usual Care | Total Grams of Carbohydrate Taken for Hypoglycemia | Days 1 to 11 | 34.8 grams of carbohydrate per day | Standard Deviation 16.21 |
| Usual Care | Total Grams of Carbohydrate Taken for Hypoglycemia | Days 2 to 11 | 34.8 grams of carbohydrate per day | Standard Deviation 16.84 |
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.
Time frame: 11 days
Population: All randomized participants who completed both periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads | 19.2 percent difference | Standard Deviation 31.4 |
| Usual Care | CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads | 18.0 percent difference | Standard Deviation 28.2 |
Other Pre-specified
Mean Daily Basal Insulin Dose
Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).
Time frame: Day 1, Days 2 to 11, each individual day 2 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 2 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 3 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 4 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 5 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 1 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Days 2 to 11 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 6 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 7 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 8 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 9 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 10 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Basal Insulin Dose | Day 11 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 10 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 2 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 6 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 3 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 9 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 4 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 7 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 5 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 11 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 1 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Day 8 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Usual Care | Mean Daily Basal Insulin Dose | Days 2 to 11 | 0.3 U/kg/day | Standard Deviation 0.002 |
Other Pre-specified
Mean Daily Bolus Insulin Dose
Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).
Time frame: Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 11 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 3 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 4 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 5 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 6 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 7 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 8 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 1 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Days 1 to 11 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Days 2 to 11 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 2 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 9 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Mean Daily Bolus Insulin Dose | Day 10 | 0.4 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 8 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 2 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 1 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 3 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 10 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 4 | 0.3 U/kg/day | Standard Deviation 0.3 |
| Usual Care | Mean Daily Bolus Insulin Dose | Days 1 to 11 | 0.3 U/kg/day | Standard Deviation 0.015 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 5 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 9 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 6 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Days 2 to 11 | 0.3 U/kg/day | Standard Deviation 0.015 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 7 | 0.3 U/kg/day | Standard Deviation 0.2 |
| Usual Care | Mean Daily Bolus Insulin Dose | Day 11 | 0.3 U/kg/day | Standard Deviation 0.2 |
Other Pre-specified
Number of Unscheduled Infusion Set Replacements
Time frame: 11 days
Population: All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Number of Unscheduled Infusion Set Replacements | Glucagon Unscheduled Infusion Set Replacements | 14 Infusion Set Relacements |
| Bionic Pancreas | Number of Unscheduled Infusion Set Replacements | Insulin Unscheduled Infusion Set Replacements | 11 Infusion Set Relacements |
| Usual Care | Number of Unscheduled Infusion Set Replacements | Insulin Unscheduled Infusion Set Replacements | 15 Infusion Set Relacements |
Other Pre-specified
Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM
Time frame: 11 days
Population: All randomized participants who completed both periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM | 96.6 percentage of possible values | Standard Deviation 1.4 |
| Usual Care | Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM | 96.3 percentage of possible values | Standard Deviation 1.6 |