Type 1 Diabetes
Conditions
Keywords
Artificial Pancreas
Brief summary
The purpose of this study is to see if an automated insulin management system (study system) can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time. The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not. At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.
Detailed description
The study phases are as follows: * Screening visit to see if you are eligible for the study and to determine how long you will need to use the study CGM (visit 1) * Up to 3 weeks using the study CGM (depends on your current CGM use), followed by an office visit (visit 2) * 2 weeks using the study insulin pump and study CGM together * Full day visit in clinic or hotel for training using the system (visit 3) * 1 week using the system without automated insulin delivery or suspension * 2-day hotel or clinic visit for closed-loop training (visit 4), * 16-19 days using the system in the evening and overnight only followed by an office visit (visit 5) * 16-19 days using the system for the full 24 hours * Final study clinic visit (visit 6) * Option 5 month extension phase of day-and-night closed-loop home use
Interventions
This investigational device system included the following components: * DiAs - a smart-phone medical platform; * Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; * Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; * Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network * Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
This commercial device system included the following components: * Dexcom G4 Platinum CGM system; * Roche Accu-Chek insulin pump
Sponsors
Jaeb Center for Health Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months. 2. Age \>=18 to \<70 years. 3. HbA1c \<10.0%; if HbA1c \<6.0% then total daily insulin must be \>=0.5 U/kg 4. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. 5. Demonstration of proper mental status and cognition for the study. 6. Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes 7. Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Awareness score of 2 or lower 8. Access to internet and cell phone service at home, and a computer for downloading device data. 9. Living with significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and available to provide assistance when system is being used at night. 10. Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration of each two-week period using the closed-loop system. 11. An understanding of and willingness to follow the protocol and sign the informed consent.
Exclusion criteria
1. Admission for diabetic ketoacidosis in the 12 months prior to enrollment. 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment. 3. History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist. 4. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist. 5. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted) 6. Cystic fibrosis. 7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) * Presence of a known adrenal disorder * Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function * Abnormal renal function test results (calculated GFR \<60); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty * Active gastroparesis * If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study * Uncontrolled thyroid disease (TSH undetectable or \>10); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise * Abuse of alcohol or recreational drugs * Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis) 7\. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol 8. Current use of the following drugs and supplements: * Acetaminophen * Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, GLP-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose * Beta blockers * Oral or injectable glucocorticoids * Any other medication that the investigator believes is a contraindication to the subject's participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent <70 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, night only (23:00 to 07:00) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent >250 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values \>250 mg/dl during study Main Phase |
| HBGI - Main Phase, Day and Night | 2 weeks | High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. |
| HBGI - Main Phase, Night Only | 2 weeks | High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. |
| HBGI - Main Phase, Day Only | 2 weeks | High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events. |
| ADRR - Main Phase, Day and Night | 2 weeks | Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above. |
| AUC 180 mg/dL - Main Phase, Day and Night | 2 weeks | Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)\*days for Patient A and 56 (mg/dl)\*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). |
| AUC 180 mg/dL - Main Phase, Night Only | 2 weeks | Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)\*days for Patient A and 56 (mg/dl)\*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). |
| AUC 180 mg/dL - Main Phase, Day Only | 2 weeks | Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)\*days for Patient A and 56 (mg/dl)\*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0). |
| Time Spent >250 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values \>250 mg/dl during study Main Phase, night only (23:00 to 07:00) |
| Time Spent >250 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values \>250 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Time Spent >300 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values \>300 mg/dl during study Main Phase |
| Time Spent >300 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values \>300 mg/dl during study Main Phase, night only (23:00 to 07:00) |
| Time Spent >300 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values \>300 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Time Spent <70 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase |
| Time Spent <70 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Time in Range 70-180 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase |
| Time in Range 70-180 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00) |
| Time in Range 70-180 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Mean Sensor Glucose - Main Phase, Day and Night | 2 weeks | Mean CGM sensor glucose during study Main Phase |
| Mean Sensor Glucose - Main Phase, Night Only | 2 weeks | Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00) |
| Mean Sensor Glucose - Main Phase, Day Only | 2 weeks | Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00) |
| Glucose Coefficient of Variation - Main Phase, Day and Night | 2 weeks | CGM Glucose Coefficient of Variation (CV) during study Main Phase |
| Glucose Coefficient of Variation - Main Phase, Night Only | 2 weeks | CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00) |
| Glucose Coefficient of Variation - Main Phase, Day Only | 2 weeks | CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00) |
| Glucose Standard Deviation - Main Phase, Day and Night | 2 weeks | CGM Glucose Standard Deviation (SD) during study Main Phase |
| Glucose Standard Deviation - Main Phase, Night Only | 2 weeks | CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00) |
| Glucose Standard Deviation - Main Phase, Day Only | 2 weeks | CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00) |
| Time Spent >180 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values \>180 mg/dl during study Main Phase |
| Time Spent >180 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values \>180 mg/dl during study Main Phase, night only (23:00 to 07:00) |
| Time Spent >180 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values \>180 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Time Spent <50 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values \<50 mg/dl during study Main Phase |
| Time Spent <50 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values \<50 mg/dl during study Main Phase, night only (23:00 to 07:00) |
| Time Spent <50 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values \<50 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| Time Spent <60 mg/dL - Main Phase, Day and Night | 2 weeks | Percentage of CGM Measured Glucose Values \<60 mg/dl during study Main Phase |
| Time Spent <60 mg/dL - Main Phase, Night Only | 2 weeks | Percentage of CGM Measured Glucose Values \<60 mg/dl during study Main Phase, night only (23:00 - 07:00) |
| Time Spent <60 mg/dL - Main Phase, Day Only | 2 weeks | Percentage of CGM Measured Glucose Values \<60 mg/dl during study Main Phase, day only (07:00 - 23:00) |
| LBGI - Main Phase, Day and Night | 2 weeks | Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. |
| LBGI - Main Phase, Night Only | 2 weeks | Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. |
| LBGI - Main Phase, Day Only | 2 weeks | Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events. |
| AOC 70 mg/dL - Main Phase, Day and Night | 2 weeks | Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold \* 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold \* 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. |
| AOC 70 mg/dL - Main Phase, Night Only | 2 weeks | Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold \* 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold \* 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. |
| AOC 70 mg/dL - Main Phase, Day Only | 2 weeks | Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold \* 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold \* 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values \<3.9 mmol/L (70 mg/dL) during study Extension Phase |
| Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values \<3.3 mmol/L (60 mg/dL) during study Extension Phase |
| Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values \<2.8 mmol/L (50 mg/dL) during study Extension Phase |
| Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL) |
| Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values \>10.0 mmol/L (180 mg/dL) during study Extension Phase |
| Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values \>13.9 mmol/L (250 mg/dL) during study Extension Phase |
| Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase | 3 months | Percentage of CGM Measured Glucose Values \>16.7 mmol/L (300 mg/dL) during study Extension Phase |
| Episodes of Severe Hypoglycemia Events - Extension Phase | 5 months | Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. |
| Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase | 5 months | Episodes of DKA events that occurred during the 5-month extension phase |
| Reported Serious Adverse Events - Extension Phase | 5 months | Reported serious adverse events during the 5-month extension phase |
| Mean Sensor Glucose - Extension Phase | 3 months | Mean CGM sensor glucose during Extension Phase |
| Change in HbA1c - Extension Phase | 5 months | Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase |
Countries
France, Israel, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Closed-Loop Control System A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.
Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:
* DiAs - a smart-phone medical platform;
* Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
* Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
* Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and
* Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Closed-Loop Control System |
|---|---|
| Age, Continuous | 44 years |
| Body-mass index (BMI) | 25 kg/m^2 |
| Daily basal insulin | 0.27 U/kg/day |
| Daily total insulin dose | 0.57 U/kg/day |
| Diabetes duration | 19 years |
| Hemoglobin A1c (HbA1c) | 7.3 percent |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment France | 5 participants |
| Region of Enrollment Israel | 5 participants |
| Region of Enrollment Italy | 5 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Time Spent <70 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <70 mg/dL - Main Phase, Night Only | 3.0 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <70 mg/dL - Main Phase, Night Only | 1.1 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <70 mg/dL - Main Phase, Night Only | 0.4 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.31t-test, 2 sided
Secondary
ADRR - Main Phase, Day and Night
Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | ADRR - Main Phase, Day and Night | 27 range scores |
| 2-Week Overnight-Only Closed-Loop | ADRR - Main Phase, Day and Night | 24 range scores |
| 2-Week 24/7 Closed-Loop | ADRR - Main Phase, Day and Night | 24 range scores |
p-value: 0.003t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.71t-test, 2 sided
Secondary
AOC 70 mg/dL - Main Phase, Day and Night
Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold \* 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold \* 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | AOC 70 mg/dL - Main Phase, Day and Night | 0.5 mg/dL |
| 2-Week Overnight-Only Closed-Loop | AOC 70 mg/dL - Main Phase, Day and Night | 0.3 mg/dL |
| 2-Week 24/7 Closed-Loop | AOC 70 mg/dL - Main Phase, Day and Night | 0.2 mg/dL |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
AOC 70 mg/dL - Main Phase, Day Only
Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold \* 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold \* 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | AOC 70 mg/dL - Main Phase, Day Only | 0.6 mg/dL |
| 2-Week Overnight-Only Closed-Loop | AOC 70 mg/dL - Main Phase, Day Only | 0.3 mg/dL |
| 2-Week 24/7 Closed-Loop | AOC 70 mg/dL - Main Phase, Day Only | 0.2 mg/dL |
p-value: 0.03t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
AOC 70 mg/dL - Main Phase, Night Only
Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold \* 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold \* 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | AOC 70 mg/dL - Main Phase, Night Only | 0.3 mg/dL |
| 2-Week Overnight-Only Closed-Loop | AOC 70 mg/dL - Main Phase, Night Only | 0.1 mg/dL |
| 2-Week 24/7 Closed-Loop | AOC 70 mg/dL - Main Phase, Night Only | 0.0 mg/dL |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.22t-test, 2 sided
Secondary
AUC 180 mg/dL - Main Phase, Day and Night
Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)\*days for Patient A and 56 (mg/dl)\*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | AUC 180 mg/dL - Main Phase, Day and Night | 15.0 mg/dL |
| 2-Week Overnight-Only Closed-Loop | AUC 180 mg/dL - Main Phase, Day and Night | 9.2 mg/dL |
| 2-Week 24/7 Closed-Loop | AUC 180 mg/dL - Main Phase, Day and Night | 11.3 mg/dL |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.39t-test, 2 sided
Secondary
AUC 180 mg/dL - Main Phase, Day Only
Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)\*days for Patient A and 56 (mg/dl)\*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | AUC 180 mg/dL - Main Phase, Day Only | 13.6 mg/dL |
| 2-Week Overnight-Only Closed-Loop | AUC 180 mg/dL - Main Phase, Day Only | 10.0 mg/dL |
| 2-Week 24/7 Closed-Loop | AUC 180 mg/dL - Main Phase, Day Only | 9.8 mg/dL |
p-value: 0.02t-test, 2 sided
p-value: 0.003t-test, 2 sided
p-value: 0.86t-test, 2 sided
Secondary
AUC 180 mg/dL - Main Phase, Night Only
Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)\*days for Patient A and 56 (mg/dl)\*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | AUC 180 mg/dL - Main Phase, Night Only | 17.7 mg/dL |
| 2-Week Overnight-Only Closed-Loop | AUC 180 mg/dL - Main Phase, Night Only | 8.4 mg/dL |
| 2-Week 24/7 Closed-Loop | AUC 180 mg/dL - Main Phase, Night Only | 9.1 mg/dL |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.06t-test, 2 sided
Secondary
Glucose Coefficient of Variation - Main Phase, Day and Night
CGM Glucose Coefficient of Variation (CV) during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Glucose Coefficient of Variation - Main Phase, Day and Night | 38 percentage |
| 2-Week Overnight-Only Closed-Loop | Glucose Coefficient of Variation - Main Phase, Day and Night | 35 percentage |
| 2-Week 24/7 Closed-Loop | Glucose Coefficient of Variation - Main Phase, Day and Night | 34 percentage |
p-value: 0.005t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.02t-test, 2 sided
Secondary
Glucose Coefficient of Variation - Main Phase, Day Only
CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Glucose Coefficient of Variation - Main Phase, Day Only | 38 percentage |
| 2-Week Overnight-Only Closed-Loop | Glucose Coefficient of Variation - Main Phase, Day Only | 37 percentage |
| 2-Week 24/7 Closed-Loop | Glucose Coefficient of Variation - Main Phase, Day Only | 35 percentage |
p-value: <0.001t-test, 2 sided
p-value: 0.13t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Glucose Coefficient of Variation - Main Phase, Night Only
CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Glucose Coefficient of Variation - Main Phase, Night Only | 36 percentage |
| 2-Week Overnight-Only Closed-Loop | Glucose Coefficient of Variation - Main Phase, Night Only | 30 percentage |
| 2-Week 24/7 Closed-Loop | Glucose Coefficient of Variation - Main Phase, Night Only | 32 percentage |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.52t-test, 2 sided
Secondary
Glucose Standard Deviation - Main Phase, Day and Night
CGM Glucose Standard Deviation (SD) during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Glucose Standard Deviation - Main Phase, Day and Night | 61 mg/dL |
| 2-Week Overnight-Only Closed-Loop | Glucose Standard Deviation - Main Phase, Day and Night | 52 mg/dL |
| 2-Week 24/7 Closed-Loop | Glucose Standard Deviation - Main Phase, Day and Night | 51 mg/dL |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.41t-test, 2 sided
Secondary
Glucose Standard Deviation - Main Phase, Day Only
CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Glucose Standard Deviation - Main Phase, Day Only | 58 mg/dL |
| 2-Week Overnight-Only Closed-Loop | Glucose Standard Deviation - Main Phase, Day Only | 55 mg/dL |
| 2-Week 24/7 Closed-Loop | Glucose Standard Deviation - Main Phase, Day Only | 53 mg/dL |
p-value: 0.02t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.06t-test, 2 sided
Secondary
Glucose Standard Deviation - Main Phase, Night Only
CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Glucose Standard Deviation - Main Phase, Night Only | 61 mg/dL |
| 2-Week Overnight-Only Closed-Loop | Glucose Standard Deviation - Main Phase, Night Only | 47 mg/dL |
| 2-Week 24/7 Closed-Loop | Glucose Standard Deviation - Main Phase, Night Only | 48 mg/dL |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.12t-test, 2 sided
Secondary
HBGI - Main Phase, Day and Night
High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | HBGI - Main Phase, Day and Night | 6.8 index scores |
| 2-Week Overnight-Only Closed-Loop | HBGI - Main Phase, Day and Night | 5.0 index scores |
| 2-Week 24/7 Closed-Loop | HBGI - Main Phase, Day and Night | 5.5 index scores |
p-value: <0.001t-test, 2 sided
p-value: 0.001t-test, 2 sided
p-value: 0.26t-test, 2 sided
Secondary
HBGI - Main Phase, Day Only
High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | HBGI - Main Phase, Day Only | 6.4 index scores |
| 2-Week Overnight-Only Closed-Loop | HBGI - Main Phase, Day Only | 5.1 index scores |
| 2-Week 24/7 Closed-Loop | HBGI - Main Phase, Day Only | 5.5 index scores |
p-value: 0.03t-test, 2 sided
p-value: 0.02t-test, 2 sided
p-value: 0.52t-test, 2 sided
Secondary
HBGI - Main Phase, Night Only
High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | HBGI - Main Phase, Night Only | 7.5 index scores |
| 2-Week Overnight-Only Closed-Loop | HBGI - Main Phase, Night Only | 5.1 index scores |
| 2-Week 24/7 Closed-Loop | HBGI - Main Phase, Night Only | 5.4 index scores |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.05t-test, 2 sided
Secondary
LBGI - Main Phase, Day and Night
Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | LBGI - Main Phase, Day and Night | 1.1 index scores |
| 2-Week Overnight-Only Closed-Loop | LBGI - Main Phase, Day and Night | 0.8 index scores |
| 2-Week 24/7 Closed-Loop | LBGI - Main Phase, Day and Night | 0.6 index scores |
p-value: 0.006t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
LBGI - Main Phase, Day Only
Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | LBGI - Main Phase, Day Only | 1.2 index scores |
| 2-Week Overnight-Only Closed-Loop | LBGI - Main Phase, Day Only | 0.9 index scores |
| 2-Week 24/7 Closed-Loop | LBGI - Main Phase, Day Only | 0.7 index scores |
p-value: 0.05t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
LBGI - Main Phase, Night Only
Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | LBGI - Main Phase, Night Only | 0.7 index scores |
| 2-Week Overnight-Only Closed-Loop | LBGI - Main Phase, Night Only | 0.4 index scores |
| 2-Week 24/7 Closed-Loop | LBGI - Main Phase, Night Only | 0.3 index scores |
p-value: <0.001t-test, 1 sided
p-value: <0.001t-test, 2 sided
p-value: 0.53t-test, 2 sided
Secondary
Mean Sensor Glucose - Main Phase, Day and Night
Mean CGM sensor glucose during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Mean Sensor Glucose - Main Phase, Day and Night | 157 mg/dL | Standard Deviation 18 |
| 2-Week Overnight-Only Closed-Loop | Mean Sensor Glucose - Main Phase, Day and Night | 149 mg/dL | Standard Deviation 12 |
| 2-Week 24/7 Closed-Loop | Mean Sensor Glucose - Main Phase, Day and Night | 153 mg/dL | Standard Deviation 12 |
p-value: 0.009t-test, 2 sided
p-value: 0.14t-test, 2 sided
p-value: 0.06t-test, 2 sided
Secondary
Mean Sensor Glucose - Main Phase, Day Only
Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Mean Sensor Glucose - Main Phase, Day Only | 154 mg/dL | Standard Deviation 19 |
| 2-Week Overnight-Only Closed-Loop | Mean Sensor Glucose - Main Phase, Day Only | 148 mg/dL | Standard Deviation 15 |
| 2-Week 24/7 Closed-Loop | Mean Sensor Glucose - Main Phase, Day Only | 152 mg/dL | Standard Deviation 14 |
p-value: 0.07t-test, 2 sided
p-value: 0.54t-test, 2 sided
p-value: 0.07t-test, 2 sided
Secondary
Mean Sensor Glucose - Main Phase, Night Only
Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Mean Sensor Glucose - Main Phase, Night Only | 163 mg/dL | Standard Deviation 23 |
| 2-Week Overnight-Only Closed-Loop | Mean Sensor Glucose - Main Phase, Night Only | 150 mg/dL | Standard Deviation 12 |
| 2-Week 24/7 Closed-Loop | Mean Sensor Glucose - Main Phase, Night Only | 154 mg/dL | Standard Deviation 13 |
p-value: 0.002t-test, 2 sided
p-value: 0.03t-test, 2 sided
p-value: 0.18t-test, 2 sided
Secondary
Time in Range 70-180 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time in Range 70-180 mg/dL - Main Phase, Day and Night | 65 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time in Range 70-180 mg/dL - Main Phase, Day and Night | 73 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time in Range 70-180 mg/dL - Main Phase, Day and Night | 73 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.91t-test, 2 sided
Secondary
Time in Range 70-180 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time in Range 70-180 mg/dL - Main Phase, Day Only | 65 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time in Range 70-180 mg/dL - Main Phase, Day Only | 70 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time in Range 70-180 mg/dL - Main Phase, Day Only | 72 percentage of CGM values |
p-value: 0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.49t-test, 2 sided
Secondary
Time in Range 70-180 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time in Range 70-180 mg/dL - Main Phase, Night Only | 61 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time in Range 70-180 mg/dL - Main Phase, Night Only | 75 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time in Range 70-180 mg/dL - Main Phase, Night Only | 72 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.2t-test, 2 sided
Secondary
Time Spent >180 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values \>180 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >180 mg/dL - Main Phase, Day and Night | 32 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >180 mg/dL - Main Phase, Day and Night | 24 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >180 mg/dL - Main Phase, Day and Night | 25 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: 0.001t-test, 2 sided
p-value: 0.26t-test, 2 sided
Secondary
Time Spent >180 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values \>180 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >180 mg/dL - Main Phase, Day Only | 31 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >180 mg/dL - Main Phase, Day Only | 23 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >180 mg/dL - Main Phase, Day Only | 25 percentage of CGM values |
p-value: 0.02t-test, 2 sided
p-value: 0.02t-test, 2 sided
p-value: 0.61t-test, 2 sided
Secondary
Time Spent >180 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values \>180 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >180 mg/dL - Main Phase, Night Only | 37 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >180 mg/dL - Main Phase, Night Only | 24 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >180 mg/dL - Main Phase, Night Only | 27 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.11t-test, 2 sided
Secondary
Time Spent >250 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values \>250 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >250 mg/dL - Main Phase, Day and Night | 7 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >250 mg/dL - Main Phase, Day and Night | 4 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >250 mg/dL - Main Phase, Day and Night | 5 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.74t-test, 2 sided
Secondary
Time Spent >250 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values \>250 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >250 mg/dL - Main Phase, Day Only | 6 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >250 mg/dL - Main Phase, Day Only | 5 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >250 mg/dL - Main Phase, Day Only | 5 percentage of CGM values |
p-value: 0.07t-test, 2 sided
p-value: 0.006t-test, 2 sided
p-value: 0.68t-test, 2 sided
Secondary
Time Spent >250 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values \>250 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >250 mg/dL - Main Phase, Night Only | 8 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >250 mg/dL - Main Phase, Night Only | 3 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >250 mg/dL - Main Phase, Night Only | 4 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.09t-test, 2 sided
Secondary
Time Spent >300 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values \>300 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >300 mg/dL - Main Phase, Day and Night | 2 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >300 mg/dL - Main Phase, Day and Night | 1 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >300 mg/dL - Main Phase, Day and Night | 1 percentage of CGM values |
p-value: 0.006t-test, 2 sided
p-value: 0.005t-test, 2 sided
p-value: 0.62t-test, 2 sided
Secondary
Time Spent >300 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values \>300 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >300 mg/dL - Main Phase, Day Only | 2 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >300 mg/dL - Main Phase, Day Only | 1 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >300 mg/dL - Main Phase, Day Only | 1 percentage of CGM values |
p-value: 0.67t-test, 2 sided
p-value: 0.09t-test, 2 sided
p-value: 0.22t-test, 2 sided
Secondary
Time Spent >300 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values \>300 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >300 mg/dL - Main Phase, Night Only | 2 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent >300 mg/dL - Main Phase, Night Only | 0 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent >300 mg/dL - Main Phase, Night Only | 0 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: 0.006t-test, 2 sided
p-value: 0.23t-test, 2 sided
Secondary
Time Spent <50 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values \<50 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <50 mg/dL - Main Phase, Day and Night | 0.8 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <50 mg/dL - Main Phase, Day and Night | 0.2 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <50 mg/dL - Main Phase, Day and Night | 0.2 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.29t-test, 2 sided
Secondary
Time Spent <50 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values \<50 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <50 mg/dL - Main Phase, Day Only | 0.9 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <50 mg/dL - Main Phase, Day Only | 0.2 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <50 mg/dL - Main Phase, Day Only | 0.2 percentage of CGM values |
p-value: 0.006t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.09t-test, 2 sided
Secondary
Time Spent <50 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values \<50 mg/dl during study Main Phase, night only (23:00 to 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <50 mg/dL - Main Phase, Night Only | 0.3 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <50 mg/dL - Main Phase, Night Only | 0.0 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <50 mg/dL - Main Phase, Night Only | 0.0 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: 0.005t-test, 2 sided
p-value: >0.99t-test, 2 sided
Secondary
Time Spent <60 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values \<60 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <60 mg/dL - Main Phase, Day and Night | 2.2 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <60 mg/dL - Main Phase, Day and Night | 1.1 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <60 mg/dL - Main Phase, Day and Night | 0.7 percentage of CGM values |
p-value: 0.002t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Time Spent <60 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values \<60 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <60 mg/dL - Main Phase, Day Only | 2.4 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <60 mg/dL - Main Phase, Day Only | 1.4 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <60 mg/dL - Main Phase, Day Only | 0.7 percentage of CGM values |
p-value: 0.04t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Time Spent <60 mg/dL - Main Phase, Night Only
Percentage of CGM Measured Glucose Values \<60 mg/dl during study Main Phase, night only (23:00 - 07:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <60 mg/dL - Main Phase, Night Only | 1.4 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <60 mg/dL - Main Phase, Night Only | 0.2 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <60 mg/dL - Main Phase, Night Only | 0.1 percentage of CGM values |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.26t-test, 2 sided
Secondary
Time Spent <70 mg/dL - Main Phase, Day and Night
Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <70 mg/dL - Main Phase, Day and Night | 4.1 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <70 mg/dL - Main Phase, Day and Night | 2.6 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <70 mg/dL - Main Phase, Day and Night | 1.7 percentage of CGM values |
p-value: 0.002t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Time Spent <70 mg/dL - Main Phase, Day Only
Percentage of CGM Measured Glucose Values \<70 mg/dl during study Main Phase, day only (07:00 - 23:00)
Time frame: 2 weeks
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <70 mg/dL - Main Phase, Day Only | 4.6 percentage of CGM values |
| 2-Week Overnight-Only Closed-Loop | Time Spent <70 mg/dL - Main Phase, Day Only | 3.2 percentage of CGM values |
| 2-Week 24/7 Closed-Loop | Time Spent <70 mg/dL - Main Phase, Day Only | 2.3 percentage of CGM values |
p-value: 0.1t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Other Pre-specified
Change in HbA1c - Extension Phase
Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase
Time frame: 5 months
Population: One participant was excluded due to missing baseline CGM data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Change in HbA1c - Extension Phase | 7.2 percentage | Standard Deviation 0.6 |
| 2-Week Overnight-Only Closed-Loop | Change in HbA1c - Extension Phase | 7.0 percentage | Standard Deviation 0.6 |
p-value: 0.23t-test, 2 sided
Other Pre-specified
Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase
Episodes of DKA events that occurred during the 5-month extension phase
Time frame: 5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase | 0 events |
Other Pre-specified
Episodes of Severe Hypoglycemia Events - Extension Phase
Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Time frame: 5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Episodes of Severe Hypoglycemia Events - Extension Phase | 0 events |
Other Pre-specified
Mean Sensor Glucose - Extension Phase
Mean CGM sensor glucose during Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Mean Sensor Glucose - Extension Phase | 8.6 mmol/L | Standard Deviation 1.1 |
| 2-Week Overnight-Only Closed-Loop | Mean Sensor Glucose - Extension Phase | 8.3 mmol/L | Standard Deviation 0.6 |
p-value: 0.25t-test, 2 sided
Other Pre-specified
Reported Serious Adverse Events - Extension Phase
Reported serious adverse events during the 5-month extension phase
Time frame: 5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Reported Serious Adverse Events - Extension Phase | 0 events |
Other Pre-specified
Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL)
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase | 66 percentage of CGM values in range |
| 2-Week Overnight-Only Closed-Loop | Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase | 77 percentage of CGM values in range |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values \>10.0 mmol/L (180 mg/dL) during study Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase | 31 percentage of CGM values >10.0 mmol/L |
| 2-Week Overnight-Only Closed-Loop | Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase | 22 percentage of CGM values >10.0 mmol/L |
p-value: 0.01t-test, 2 sided
Other Pre-specified
Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values \>13.9 mmol/L (250 mg/dL) during study Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase | 6 percentage of CGM values in range |
| 2-Week Overnight-Only Closed-Loop | Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase | 3 percentage of CGM values in range |
p-value: 0.006t-test, 2 sided
Other Pre-specified
Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values \>16.7 mmol/L (300 mg/dL) during study Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase | 2 percentage of CGM values in range |
| 2-Week Overnight-Only Closed-Loop | Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase | 0 percentage of CGM values in range |
p-value: 0.14t-test, 2 sided
Other Pre-specified
Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values \<2.8 mmol/L (50 mg/dL) during study Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase | 1.0 mmol/L |
| 2-Week Overnight-Only Closed-Loop | Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase | 0.1 mmol/L |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values \<3.3 mmol/L (60 mg/dL) during study Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase | 2.2 mmol/L |
| 2-Week Overnight-Only Closed-Loop | Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase | 0.3 mmol/L |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase
Percentage of CGM Measured Glucose Values \<3.9 mmol/L (70 mg/dL) during study Extension Phase
Time frame: 3 months
Population: One subject had missing CGM data at baseline and was not included in this analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2-Week Baseline Sensor-Augmented Pump | Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase | 4.1 mmol/L |
| 2-Week Overnight-Only Closed-Loop | Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase | 1.3 mmol/L |
p-value: <0.001t-test, 2 sided