Type 1 Diabetes
Conditions
Keywords
bionic pancreas, artificial pancreas, insulin, glucagon, continuous glucose monitoring (CGM), outpatient, insulin pump, pediatrics, children, camp, summer camp
Brief summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improve glycemic control vs. usual care for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.
Interventions
DEVICEBionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
OTHERUsual Care
As a comparator control, usual diabetes camp care with the participant's own insulin pump.
Sponsors
Boston University
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Age 6-11 years with type 1 diabetes for at least one year * Diabetes managed using an insulin infusion pump for ≥ three months * Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily) * Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion)
Exclusion criteria
* Unable to provide informed consent, informed assent or parental consent * Unable to comply with study procedures * 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 * End stage renal disease on dialysis (hemodialysis or peritoneal dialysis) * Pregnancy (positive urine human chorionic gonadotropin \[HCG\]) * 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 * Personal history of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma * History of prolonged QT or arrhythmia, congenital heart disease or current known cardiac disease * Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes (T1D) at the time of the study * Seizure disorder, history of any seizure within the last two years, or ongoing treatment with anticonvulsants * 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 second generation anti-psychotic medications, which are known to affect glucose regulation. * Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio-frequency (RF) interference * Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2 (SGLT-2) inhibitors) anti-diabetic medications * History of adverse reaction to glucagon (including allergy) besides nausea and vomiting. * Unwilling or unable to completely avoid acetaminophen during the comparator and bionic pancreas arms of 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 * Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5 | Days 2 to 5 of each period | Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged. |
| Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5 | Days 2 to 5 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 through 5 was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | Days 1 to 5 of each period | Glucose readings 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), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L). |
| Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | Days 2 to 5 of each period | Glucose readings 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), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L). |
| Percentage of Participants With Mean CGMG Glucose <154 mg/dL | Day 1, Days 1-5, and Days 2-5 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 Hemoglobin A1C of 7.0%. |
| Percentage of Participants With Mean CGMG Glucose <169 mg/dL | Day 1, Days 1-5, and Days 2-5 of each period | Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%. |
| Percentage of Participants With Mean CGMG Glucose <183 mg/dL | Day 1, Days 1-5, and Days 2-5 of each period | Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%. |
| Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | Days 1-5 | 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. |
| Mean Plasma Glucose Values | Day 1, Days 1 to 5, and Days 2 to 5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged. |
| Percentage of Time With Plasma Glucose Values by Ranges on Day 1 | Day 1 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L). |
| Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 | Days 1 to 5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dL (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dL (2.8 mmol/L). |
| Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 | Days 2 to 5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L). |
| Percentage of Participants With Mean Plasma Glucose <154 mg/dL | Day 1, Days 1 to 5, and Days 2 to 5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%. |
| Percentage of Participants With Mean Plasma Glucose <169 mg/dL | Day 1, Days 1 to 5, and Days 2 to 5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%. |
| Percentage of Participants With Mean Plasma Glucose <183 mg/dL | Day 1, Days 1 to 5, and Days 2 to 5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%. |
| Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | Days 1-5 | 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 Data Was Used by Participants as Part of Their Usual Care | Day 1, Days 1-5, and Days 2-5 of the Usual Care Period | The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management. |
| Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Day 1, Days 1-5, and Days 2-5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported. |
| Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Day 1, Days 1-5, and Days 2-5 of each period | Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. |
| Mean CGMG Values | Day 1 and Days 1-5 in each period | Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged. |
| Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Day 1, Days 1-5, and Days 2-5 of each period | Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day). |
| Daily Basal Insulin Dose in the Bionic Pancreas Period | Day 1 through Day 5 | The bionic pancreas automatically adapted insulin dosing to each individual's needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg). |
| Daily Bolus Insulin Dose in the Bionic Pancreas Period | Day 1 through Day 5 | The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg). |
| Carbohydrate Intake | Day 1, Days 1-5 and Days 2-5 | Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was \<80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day). |
| Number of Unscheduled Infusion Set Changes | Day 1 | Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin. |
| Number of Bionic Pancreas Local Infusion Site Reactions | Day 1, Days 1-5 and Days 2-5 | Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present. |
| Mean Nausea Index Score Using a Visual Analogue Scale (VAS) | Day 1, Days 1-5, and Days 2-5 in 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 from Day 1 to Day 5 were calculated |
| Number of Severe Hypoglycemic Events | Day 1, Days 1-5 and Days 2-5 | A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person. |
| Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period | 5 days | Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity. |
| Percentage of Time Without CGM Monitoring Data | 5 days | Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal. |
| Change From Baseline in Body Weight | 5 days | The change in body weight collected at Day 5 of each period 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. |
| Reliability Index | Day 1, Days 1-5, and Days 2-5 in each period | Reliability index was calculated as the percentage of time values were actually recorded by CGM. |
| List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution | 5 days | — |
| Number of Unscheduled CGM Sensor Changes | 5 days | The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value. |
| Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period | 5 days | The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period. |
| Percentage of Participants Using Pramlintide During the Usual Care Period | 5 days | The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period. |
| Insulin Total Daily Dose | 11 days | Insulin total daily dose is reported in units per kilogram per day (U/kg/day). |
| Percentage of Time With CGMG Concentration by Ranges During Day 1 | Day 1 of each period | Glucose readings 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), 70-180 mg/dL (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants who completed both periods of the study. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Categorical <=18 years | 19 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.8 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 19 | 13 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.
Time frame: Days 2 to 5 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 5 | 136.8 milligrams/deciliter (mg/dL) | Standard Deviation 10.8 |
| Usual Care | Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5 | 167.4 milligrams/deciliter (mg/dL) | Standard Deviation 30.6 |
Primary
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
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 through 5 was calculated.
Time frame: Days 2 to 5 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 5 | 1.2 percentage of time | Standard Deviation 1.1 |
| Usual Care | Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5 | 2.8 percentage of time | Standard Deviation 1.2 |
Secondary
Carbohydrate Intake
Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was \<80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).
Time frame: Day 1, Days 1-5 and Days 2-5
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Carbohydrate Intake | Day 1 | 5.51 g/kg/day | Standard Deviation 1.46 |
| Bionic Pancreas | Carbohydrate Intake | Days 1 to 5 | 6.09 g/kg/day | Standard Deviation 1.53 |
| Bionic Pancreas | Carbohydrate Intake | Days 2 to 5 | 6.24 g/kg/day | Standard Deviation 1.62 |
| Usual Care | Carbohydrate Intake | Day 1 | 6.09 g/kg/day | Standard Deviation 2.08 |
| Usual Care | Carbohydrate Intake | Days 1 to 5 | 6.66 g/kg/day | Standard Deviation 1.72 |
| Usual Care | Carbohydrate Intake | Days 2 to 5 | 6.80 g/kg/day | Standard Deviation 1.7 |
Secondary
Change From Baseline in Body Weight
The change in body weight collected at Day 5 of each period 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: 5 days
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Change From Baseline in Body Weight | 0.07 kg | Standard Deviation 0.63 |
| Usual Care | Change From Baseline in Body Weight | 0.28 kg | Standard Deviation 0.81 |
Secondary
Daily Basal Insulin Dose in the Bionic Pancreas Period
The bionic pancreas automatically adapted insulin dosing to each individual's needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).
Time frame: Day 1 through Day 5
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 | Daily Basal Insulin Dose in the Bionic Pancreas Period | Day 1 | 0.2 U/kg/day | Standard Deviation 0 |
| Bionic Pancreas | Daily Basal Insulin Dose in the Bionic Pancreas Period | Day 2 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Daily Basal Insulin Dose in the Bionic Pancreas Period | Day 3 | 0.3 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Daily Basal Insulin Dose in the Bionic Pancreas Period | Day 4 | 0.3 U/kg/day | Standard Deviation 0 |
| Bionic Pancreas | Daily Basal Insulin Dose in the Bionic Pancreas Period | Day 5 | 0.3 U/kg/day | Standard Deviation 0.1 |
Secondary
Daily Bolus Insulin Dose in the Bionic Pancreas Period
The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).
Time frame: Day 1 through Day 5
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 | Daily Bolus Insulin Dose in the Bionic Pancreas Period | Day 1 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Daily Bolus Insulin Dose in the Bionic Pancreas Period | Day 2 | 0.4 U/kg/day | Standard Deviation 0.2 |
| Bionic Pancreas | Daily Bolus Insulin Dose in the Bionic Pancreas Period | Day 3 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Daily Bolus Insulin Dose in the Bionic Pancreas Period | Day 4 | 0.4 U/kg/day | Standard Deviation 0.1 |
| Bionic Pancreas | Daily Bolus Insulin Dose in the Bionic Pancreas Period | Day 5 | 0.4 U/kg/day | Standard Deviation 0.1 |
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 1-5, and Days 2-5 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 | 11.9 µg/kg/day | Standard Deviation 5.2 |
| Bionic Pancreas | Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Days 1 to 5 | 11.1 µg/kg/day | Standard Deviation 3.8 |
| Bionic Pancreas | Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm | Days 2 to 5 | 10.9 µg/kg/day | Standard Deviation 4 |
Secondary
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.
Time frame: Day 1, Days 1-5, and Days 2-5 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bionic Pancreas | Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Day 1 | 1.6 grams of carbohydrate |
| Bionic Pancreas | Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 1 to 5 | 7.3 grams of carbohydrate |
| Bionic Pancreas | Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 2 to 5 | 5.7 grams of carbohydrate |
| Usual Care | Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Day 1 | 2.2 grams of carbohydrate |
| Usual Care | Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 1 to 5 | 12.7 grams of carbohydrate |
| Usual Care | Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 2 to 5 | 9.6 grams of carbohydrate |
Secondary
Insulin Total Daily Dose
Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time frame: 11 days
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Insulin Total Daily Dose | Day 1 | 0.7 U/kg/day | Standard Deviation 0.2 |
| Bionic Pancreas | Insulin Total Daily Dose | Days 1 to 5 | 0.68 U/kg/day | Standard Deviation 0.14 |
| Bionic Pancreas | Insulin Total Daily Dose | Days 2 to 5 | 0.68 U/kg/day | Standard Deviation 0.15 |
| Usual Care | Insulin Total Daily Dose | Day 1 | 0.66 U/kg/day | Standard Deviation 0.15 |
| Usual Care | Insulin Total Daily Dose | Days 1 to 5 | 0.68 U/kg/day | Standard Deviation 0.13 |
| Usual Care | Insulin Total Daily Dose | Days 2 to 5 | 0.68 U/kg/day | Standard Deviation 0.13 |
Secondary
List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution
Time frame: 5 days
Population: Data was not collected and analyzed to this level of detail.
Secondary
Mean CGMG Values
Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.
Time frame: Day 1 and Days 1-5 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 | 153.6 mg/dL | Standard Deviation 19.7 |
| Bionic Pancreas | Mean CGMG Values | Days 1 to 5 | 140.6 mg/dL | Standard Deviation 12 |
| Usual Care | Mean CGMG Values | Days 1 to 5 | 169.9 mg/dL | Standard Deviation 27.6 |
| Usual Care | Mean CGMG Values | Day 1 | 179.2 mg/dL | Standard Deviation 37.8 |
Secondary
Mean Nausea Index Score Using a Visual Analogue 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 from Day 1 to Day 5 were calculated
Time frame: Day 1, Days 1-5, and Days 2-5 in 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 Analogue Scale (VAS) | Day 1 | 1.1 cm | Standard Deviation 2.2 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analogue Scale (VAS) | Days 1 to 5 | 1.3 cm | Standard Deviation 2 |
| Bionic Pancreas | Mean Nausea Index Score Using a Visual Analogue Scale (VAS) | Days 2 to 5 | 1.4 cm | Standard Deviation 2.3 |
| Usual Care | Mean Nausea Index Score Using a Visual Analogue Scale (VAS) | Day 1 | 0.9 cm | Standard Deviation 2.2 |
| Usual Care | Mean Nausea Index Score Using a Visual Analogue Scale (VAS) | Days 1 to 5 | 1.4 cm | Standard Deviation 1.8 |
| Usual Care | Mean Nausea Index Score Using a Visual Analogue Scale (VAS) | Days 2 to 5 | 1.5 cm | Standard Deviation 1.8 |
Secondary
Mean Plasma Glucose Values
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.
Time frame: Day 1, Days 1 to 5, and Days 2 to 5 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Mean Plasma Glucose Values | Day 1 | 137.2 mg/dL | Standard Deviation 20.1 |
| Bionic Pancreas | Mean Plasma Glucose Values | Days 1 to 5 | 136.8 mg/dL | Standard Deviation 7.2 |
| Bionic Pancreas | Mean Plasma Glucose Values | Days 2 to 5 | 135.8 mg/dL | Standard Deviation 5.4 |
| Usual Care | Mean Plasma Glucose Values | Day 1 | 169.7 mg/dL | Standard Deviation 32.2 |
| Usual Care | Mean Plasma Glucose Values | Days 1 to 5 | 176.4 mg/dL | Standard Deviation 25.2 |
| Usual Care | Mean Plasma Glucose Values | Days 2 to 5 | 178.8 mg/dL | Standard Deviation 27.4 |
Secondary
Number of Bionic Pancreas Local Infusion Site Reactions
Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.
Time frame: Day 1, Days 1-5 and Days 2-5
Population: All randomized participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Number of Bionic Pancreas Local Infusion Site Reactions | Day 1 | 1 infusion site reactions |
| Bionic Pancreas | Number of Bionic Pancreas Local Infusion Site Reactions | Days 1 to 5 | 3 infusion site reactions |
| Bionic Pancreas | Number of Bionic Pancreas Local Infusion Site Reactions | Days 2 to 5 | 2 infusion site reactions |
Secondary
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.
Time frame: Day 1, Days 1-5, and Days 2-5 of each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bionic Pancreas | Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Day 1 | 1 carbohydrate interventions |
| Bionic Pancreas | Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 1 to 5 | 3 carbohydrate interventions |
| Bionic Pancreas | Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 2 to 5 | 2 carbohydrate interventions |
| Usual Care | Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Day 1 | 1 carbohydrate interventions |
| Usual Care | Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 1 to 5 | 5 carbohydrate interventions |
| Usual Care | Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL | Days 2 to 5 | 3 carbohydrate interventions |
Secondary
Number of CGMG Reported 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 1-5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <70 mg/dl | 9.4 times below threshold | Standard Deviation 5.8 |
| Bionic Pancreas | Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <60 mg/dl | 4.4 times below threshold | Standard Deviation 3.3 |
| Bionic Pancreas | Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <50 mg/dl | 1.9 times below threshold | Standard Deviation 1.9 |
| Usual Care | Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <70 mg/dl | 9.4 times below threshold | Standard Deviation 5.1 |
| Usual Care | Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <60 mg/dl | 6.3 times below threshold | Standard Deviation 3 |
| Usual Care | Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <50 mg/dl | 3.1 times below threshold | Standard Deviation 2.1 |
Secondary
Number of Plasma Glucose Reported 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 1-5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <70 mg/dl | 2.84 times below threshold | Standard Deviation 2.39 |
| Bionic Pancreas | Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <50 mg/dl | 0.47 times below threshold | Standard Deviation 0.61 |
| Bionic Pancreas | Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <60 mg/dl | 1.26 times below threshold | Standard Deviation 1.19 |
| Usual Care | Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <50 mg/dl | 0.53 times below threshold | Standard Deviation 0.61 |
| Usual Care | Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <60 mg/dl | 2.11 times below threshold | Standard Deviation 1.97 |
| Usual Care | Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) | <70 mg/dl | 4.79 times below threshold | Standard Deviation 3.52 |
Secondary
Number of 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: Day 1, Days 1-5 and Days 2-5
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Number of Severe Hypoglycemic Events | Day 1 | 0 severe hypoglycemic events |
| Bionic Pancreas | Number of Severe Hypoglycemic Events | Days 1 to 5 | 0 severe hypoglycemic events |
| Bionic Pancreas | Number of Severe Hypoglycemic Events | Days 2 to 5 | 0 severe hypoglycemic events |
| Usual Care | Number of Severe Hypoglycemic Events | Day 1 | 0 severe hypoglycemic events |
| Usual Care | Number of Severe Hypoglycemic Events | Days 1 to 5 | 0 severe hypoglycemic events |
| Usual Care | Number of Severe Hypoglycemic Events | Days 2 to 5 | 0 severe hypoglycemic events |
Secondary
Number of Unscheduled CGM Sensor Changes
The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
Time frame: 5 days
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bionic Pancreas | Number of Unscheduled CGM Sensor Changes | 3 CGM sensor changes |
| Usual Care | Number of Unscheduled CGM Sensor Changes | 5 CGM sensor changes |
Secondary
Number of Unscheduled Infusion Set Changes
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Time frame: Day 1
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Fell out | 1 unscheduled infusion set changes |
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Failure | 0 unscheduled infusion set changes |
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Pain | 1 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Fell out | 0 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Failure | 1 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Pain | 0 unscheduled infusion set changes |
Secondary
Number of Unscheduled Infusion Set Changes
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Time frame: Days 2-5
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Fell out | 6 unscheduled infusion set changes |
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Failure | 2 unscheduled infusion set changes |
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Pain | 2 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Fell out | 1 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Failure | 4 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Pain | 0 unscheduled infusion set changes |
Secondary
Number of Unscheduled Infusion Set Changes
Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.
Time frame: Days 1-5
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Fell out | 7 unscheduled infusion set changes |
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Failure | 2 unscheduled infusion set changes |
| Bionic Pancreas | Number of Unscheduled Infusion Set Changes | Pain | 3 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Fell out | 1 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Failure | 5 unscheduled infusion set changes |
| Usual Care | Number of Unscheduled Infusion Set Changes | Pain | 0 unscheduled infusion set changes |
Secondary
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.
Time frame: Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bionic Pancreas | Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care | Day 1 | 0 percentage of days |
| Bionic Pancreas | Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care | Days 1 to 5 | 0 percentage of days |
| Bionic Pancreas | Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care | Days 2 to 5 | 0 percentage of days |
Secondary
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
Time frame: 5 days
Population: All participants who completed both periods of the study. Results are reported for the Usual Care period only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bionic Pancreas | Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period | 0 percentage of participants |
Secondary
Percentage of Participants Using Pramlintide During the Usual Care Period
The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.
Time frame: 5 days
Population: All participants who completed both periods of the study. Results are reported for the Usual Care period only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bionic Pancreas | Percentage of Participants Using Pramlintide During the Usual Care Period | 0 percentage of participants |
Secondary
Percentage of Participants With Mean CGMG Glucose <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 Hemoglobin A1C of 7.0%.
Time frame: Day 1, Days 1-5, and Days 2-5 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 Glucose <154 mg/dL | Day 1 | 57.9 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG Glucose <154 mg/dL | Days 1 to 5 | 84.2 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG Glucose <154 mg/dL | Days 2 to 5 | 94.7 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <154 mg/dL | Day 1 | 15.8 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <154 mg/dL | Days 1 to 5 | 36.8 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <154 mg/dL | Days 2 to 5 | 42.1 percentage of participants |
Secondary
Percentage of Participants With Mean CGMG Glucose <169 mg/dL
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
Time frame: Day 1, Days 1-5, and Days 2-5 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 Glucose <169 mg/dL | Day 1 | 89.5 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG Glucose <169 mg/dL | Days 1 to 5 | 94.7 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG Glucose <169 mg/dL | Days 2 to 5 | 100 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <169 mg/dL | Day 1 | 36.8 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <169 mg/dL | Days 1 to 5 | 57.9 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <169 mg/dL | Days 2 to 5 | 68.4 percentage of participants |
Secondary
Percentage of Participants With Mean CGMG Glucose <183 mg/dL
Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
Time frame: Day 1, Days 1-5, and Days 2-5 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 Glucose <183 mg/dL | Day 1 | 89.5 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG Glucose <183 mg/dL | Days 1 to 5 | 100 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean CGMG Glucose <183 mg/dL | Days 2 to 5 | 100 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <183 mg/dL | Day 1 | 57.9 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <183 mg/dL | Days 1 to 5 | 68.4 percentage of participants |
| Usual Care | Percentage of Participants With Mean CGMG Glucose <183 mg/dL | Days 2 to 5 | 73.7 percentage of participants |
Secondary
Percentage of Participants With Mean Plasma Glucose <154 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.
Time frame: Day 1, Days 1 to 5, and Days 2 to 5 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 Plasma Glucose <154 mg/dL | Day 1 | 84 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean Plasma Glucose <154 mg/dL | Days 1 to 5 | 100 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean Plasma Glucose <154 mg/dL | Days 2 to 5 | 100 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <154 mg/dL | Day 1 | 37 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <154 mg/dL | Days 1 to 5 | 16 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <154 mg/dL | Days 2 to 5 | 11 percentage of participants |
Secondary
Percentage of Participants With Mean Plasma Glucose <169 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.
Time frame: Day 1, Days 1 to 5, and Days 2 to 5 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 Plasma Glucose <169 mg/dL | Day 1 | 95 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean Plasma Glucose <169 mg/dL | Days 1 to 5 | 100 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean Plasma Glucose <169 mg/dL | Days 2 to 5 | 100 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <169 mg/dL | Days 1 to 5 | 37 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <169 mg/dL | Day 1 | 58 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <169 mg/dL | Days 2 to 5 | 53 percentage of participants |
Secondary
Percentage of Participants With Mean Plasma Glucose <183 mg/dL
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.
Time frame: Day 1, Days 1 to 5, and Days 2 to 5 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 Plasma Glucose <183 mg/dL | Day 1 | 95 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean Plasma Glucose <183 mg/dL | Days 1 to 5 | 100 percentage of participants |
| Bionic Pancreas | Percentage of Participants With Mean Plasma Glucose <183 mg/dL | Days 2 to 5 | 100 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <183 mg/dL | Day 1 | 68 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <183 mg/dL | Days 1 to 5 | 68 percentage of participants |
| Usual Care | Percentage of Participants With Mean Plasma Glucose <183 mg/dL | Days 2 to 5 | 63 percentage of participants |
Secondary
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
Time frame: 5 days
Population: All randomized participants who completed both periods of the study. Reported for the Bionic Pancreas period only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period | Insulin Pump: Loss of Wireless Connectivity | 4.9 percentage of time | Standard Deviation 2.5 |
| Bionic Pancreas | Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period | Glucagon Pump: Loss of Wireless Connectivity | 6.1 percentage of time | Standard Deviation 3.1 |
Secondary
Percentage of Time With CGMG Concentration by Ranges During Day 1
Glucose readings 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), 70-180 mg/dL (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 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 | < 50 mg/dL (2.8 mmol/L) | 0.2 percentage of time | Standard Deviation 0.6 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 70 mg/dL (3.9 mmol/L) | 1.8 percentage of time | Standard Deviation 2 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | 70-180 mg/dL (3.9 to 10.0 mmol/L) | 71.6 percentage of time | Standard Deviation 11.7 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Day 1 | > 180 mg/dL (10.0 mmol/L) | 26.6 percentage of time | Standard Deviation 11.3 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | > 180 mg/dL (10.0 mmol/L) | 44.2 percentage of time | Standard Deviation 23.4 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 50 mg/dL (2.8 mmol/L) | 1.0 percentage of time | Standard Deviation 2.6 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | 70-180 mg/dL (3.9 to 10.0 mmol/L) | 52.1 percentage of time | Standard Deviation 21.3 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Day 1 | < 70 mg/dL (3.9 mmol/L) | 3.7 percentage of time | Standard Deviation 4.5 |
Secondary
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
Glucose readings 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), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).
Time frame: Days 1 to 5 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 5 | < 50 mg/dl (2.8 mmol/L) | 0.4 percentage of time | Standard Deviation 0.4 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | < 70 mg/dl (3.9 mmol/L) | 2.7 percentage of time | Standard Deviation 1.8 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 78.8 percentage of time | Standard Deviation 7.4 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | > 180 mg/dL (10.0 mmol/L) | 18.5 percentage of time | Standard Deviation 6.6 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | > 180 mg/dL (10.0 mmol/L) | 37.9 percentage of time | Standard Deviation 15.4 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | < 50 mg/dl (2.8 mmol/L) | 1.1 percentage of time | Standard Deviation 0.8 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 56.5 percentage of time | Standard Deviation 13.9 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 | < 70 mg/dl (3.9 mmol/L) | 5.6 percentage of time | Standard Deviation 2.5 |
Secondary
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
Glucose readings 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), 70-180 mg/dl (3.9 to 10.0 mmol/L), \> 180 mg/dL (10.0 mmol/L).
Time frame: Days 2 to 5 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 5 | < 50 mg/dl (2.8 mmol/L) | 0.4 percentage of time | Standard Deviation 0.5 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | < 70 mg/dl (3.9 mmol/L) | 2.9 percentage of time | Standard Deviation 2.1 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | > 180 mg/dL (10.0 mmol/L) | 16.5 percentage of time | Standard Deviation 6.4 |
| Bionic Pancreas | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 80.6 percentage of time | Standard Deviation 7.4 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | > 180 mg/dL (10.0 mmol/L) | 36.3 percentage of time | Standard Deviation 15.7 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | < 50 mg/dl (2.8 mmol/L) | 1.1 percentage of time | Standard Deviation 0.8 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | < 70 mg/dl (3.9 mmol/L) | 6.1 percentage of time | Standard Deviation 2.8 |
| Usual Care | Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 | 70-180 mg/dl (3.9 to 10.0 mmol/L) | 57.6 percentage of time | Standard Deviation 14 |
Secondary
Percentage of Time Without CGM Monitoring Data
Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
Time frame: 5 days
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bionic Pancreas | Percentage of Time Without CGM Monitoring Data | 4.2 percentage of time | Standard Deviation 1.9 |
| Usual Care | Percentage of Time Without CGM Monitoring Data | 5.1 percentage of time | Standard Deviation 1.9 |
Secondary
Percentage of Time With Plasma Glucose Values by Ranges on Day 1
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 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 Plasma Glucose Values by Ranges on Day 1 | < 70 mg/dL (3.9 mmol/L) | 4.4 percentage of values | Standard Deviation 0.1 |
| Bionic Pancreas | Percentage of Time With Plasma Glucose Values by Ranges on Day 1 | < 60 mg/dL (3.3 mmol/L) | 0.9 percentage of values | Standard Deviation 0.4 |
| Bionic Pancreas | Percentage of Time With Plasma Glucose Values by Ranges on Day 1 | < 50 mg/dL (2.8 mmol/L) | 0 percentage of values | Standard Deviation 0 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Day 1 | < 70 mg/dL (3.9 mmol/L) | 3.7 percentage of values | Standard Deviation 0.07 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Day 1 | < 60 mg/dL (3.3 mmol/L) | 2.8 percentage of values | Standard Deviation 0.06 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Day 1 | < 50 mg/dL (2.8 mmol/L) | 0.9 percentage of values | Standard Deviation 0.04 |
Secondary
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dL (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dL (2.8 mmol/L).
Time frame: Days 1 to 5 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 Plasma Glucose Values by Ranges on Days 1 to 5 | < 70 mg/dL (3.9 mmol/L) | 2.7 percentage of values | Standard Deviation 0.03 |
| Bionic Pancreas | Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 | < 60 mg/dL (3.3 mmol/L) | 1.1 percentage of values | Standard Deviation 0.02 |
| Bionic Pancreas | Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 | < 50 mg/dL (2.8 mmol/L) | 0.4 percentage of values | Standard Deviation 0.01 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 | < 70 mg/dL (3.9 mmol/L) | 4.3 percentage of values | Standard Deviation 0.04 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 | < 60 mg/dL (3.3 mmol/L) | 2.1 percentage of values | Standard Deviation 0.02 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 | < 50 mg/dL (2.8 mmol/L) | 0.5 percentage of values | Standard Deviation 0.01 |
Secondary
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: \< 70 mg/dl (3.9 mmol/L), \< 60 mg/dL (3.3 mmol/L), \< 50 mg/dl (2.8 mmol/L).
Time frame: Days 2 to 5 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 Plasma Glucose Values by Ranges on Days 2 to 5 | < 70 mg/dl (3.9 mmol/L) | 2.2 percentage of values | Standard Deviation 0.03 |
| Bionic Pancreas | Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 | < 60 mg/dL (3.3 mmol/L) | 1.1 percentage of values | Standard Deviation 0.02 |
| Bionic Pancreas | Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 | < 50 mg/dl (2.8 mmol/L) | 0.4 percentage of values | Standard Deviation 0.013 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 | < 70 mg/dl (3.9 mmol/L) | 4.4 percentage of values | Standard Deviation 0.04 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 | < 60 mg/dL (3.3 mmol/L) | 1.9 percentage of values | Standard Deviation 0.02 |
| Usual Care | Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 | < 50 mg/dl (2.8 mmol/L) | 0.2 percentage of values | Standard Deviation 0.01 |
Secondary
Reliability Index
Reliability index was calculated as the percentage of time values were actually recorded by CGM.
Time frame: Day 1, Days 1-5, and Days 2-5 in each period
Population: All randomized participants who completed both periods of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bionic Pancreas | Reliability Index | Day 1 | 95.3 percentage of time | Standard Deviation 3.76 |
| Bionic Pancreas | Reliability Index | Days 1 to 5 | 95.4 percentage of time | Standard Deviation 2 |
| Bionic Pancreas | Reliability Index | Days 2 to 5 | 95.8 percentage of time | Standard Deviation 1.9 |
| Usual Care | Reliability Index | Day 1 | 95.1 percentage of time | Standard Deviation 2.28 |
| Usual Care | Reliability Index | Days 1 to 5 | 93.1 percentage of time | Standard Deviation 3 |
| Usual Care | Reliability Index | Days 2 to 5 | 95.0 percentage of time | Standard Deviation 1.9 |