Type 1 Diabetes
Conditions
Keywords
Artificial Pancreas, Automated Insulin Delivery, Closed Loop Control, Continuous Glucose Monitor (CGM), interoperable Artificial Pancreas System (iAPS)
Brief summary
The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.
Detailed description
A randomized crossover trial will compare the efficacy and safety of an automated insulin delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for 10-14 days will be conducted prior to the crossover trial.
Interventions
DEVICEinteroperable Artificial Pancreas System (iAPS)
Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
OTHERSensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
Use of personal pump with study CGM & glucometer at home for 13 weeks.
Sponsors
Harvard University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Sansum Diabetes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year * Using an insulin pump for at least 3 months (which may include use of automated features) * Familiarity and use of a carbohydrate ratio for meal boluses * Age ≥18.0 years old * 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 serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. * If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study * Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only * Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study * Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial * Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol
Exclusion criteria
* Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial. * Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months * Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months * Hemophilia or any other bleeding disorder * A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk. History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment * Participation in another pharmaceutical or device trial at the time of enrollment or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent CGM Time in Range 70-180 mg/dL | 13 weeks | This results shown is mean percent time in range 70-180 mg/dL. |
| Non-inferiority for CGM Time <54 mg/dL | 13 weeks | Superiority for time in range 70-180 mg/dL and non-inferiority for time \<54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Time < 54 (Superiority) | 13 weeks | CGM time \< 54 mg/dL (Superiority) |
| CGM Time in Range 70-140 mg/dL | 13 weeks | CGM-measured % in range 70-140 mg/dL |
| Standard Deviation | 13 weeks | CGM measured glucose variability measured with the standard deviation (SD) |
| CGM Time < 60 | 13 weeks | CGM time \< 60 mg/dL |
| LBGI | 13 weeks | Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 \< LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 \< LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI \> 5.0 is associated with high risk of hypoglycemia. |
| CGM Time > 300 | 13 weeks | CGM time \> 300 mg/dL |
| HBGI | 13 weeks | High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia |
| HbA1c at 13 Weeks | 13 weeks | Hemiglobin A1c measured after completing each study arm |
| Number of Participants With HbA1c <7.0% at 13 Weeks | 13 weeks | Number of participants HbA1c \<7.0% after completing each study arm |
| Number of Participants With HbA1c <7.5% at 13 Weeks | 3 months | Number of participants HbA1c \<7.5% after completing each study arm |
| Diabetes Distress Scale at 13 Weeks - Total Score | 13 weeks | Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress. |
| Glucose Monitoring Satisfaction Survey (Total Scale) | 13 weeks | The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5) |
| Hypoglycemia Confidence Scale | 13 weeks | Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4. |
| INSPIRE Survey Scores - Following Study System Period Only | 13 weeks | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items. |
| SUS Survey Scores - Following Study System Period | 13 weeks | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability |
| Total Daily Insulin | 13 weeks | Total Daily Insulin (units) |
| Basal: Bolus Insulin Ratio | 13 weeks | Basal: bolus insulin ratio |
| CGM Mean Glucose | 13 weeks | CGM-measured mean glucose (mg/dL) |
| CGM Time > 180 | 13 weeks | CGM time \> 180 mg/dL |
| CGM Time > 250 | 13 weeks | CGM time \> 250 mg/dL |
| CGM Time < 70 | 13 weeks | CGM time \< 70 mg/dL |
| Coefficient of Variation | 13 weeks | CGM measured glucose variability measured with the coefficient of variation (CV) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | 13 weeks | Ketone events defined as day with ketone level \>1.0 mmol/L |
| CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | 3 months | CGM-measured hypoglycemic events (\>15 minutes with glucose concentration \<54 mg/dL) in each arm. |
| CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | 3 months | CGM-measured hyperglycemic events (\>15 minutes with glucose concentration \>300 mg/dL) in each arm. |
| BG-measured Hypoglycemic Events (One BG Record <54 mg/dL | 13 weeks | BG-measured Hypoglycemic Events (One BG Record \<54 mg/dL |
| Worsening of HbA1c From Baseline to 26 Weeks by >0.5% | 13 weeks | Worsening of HbA1c from baseline to 26 weeks by \>0.5% |
| Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) | 13 weeks | Other serious adverse events (SAE) and serious adverse device events (SADE) |
| Adverse Device Effects (ADE) | 13 weeks | Adverse device effects (ADE) |
| Unanticipated Adverse Device Effects (UADE) | 13 weeks | Unanticipated adverse device effects (UADE) |
| Number of Participants With SH Events | 13 weeks | For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group |
| SH Event Rate Per 100 Person-years | 13 weeks | For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate. |
| Number of Participants With DKA Events | 13 weeks | For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated. |
| DKA Event Rate Per 100 Person-years | 13 weeks | For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate. |
| Any Adverse Event Rate Per 100 Person-years | 13 weeks | For this outcome, the adverse event rate per 100 person-years calculated as a rate. |
| Number of Participants With Diabetic Ketoacidosis (Per Protocol) | 13 weeks | Diabetic ketoacidosis (per protocol) |
| CGM Metrics by Time of Day | 13 weeks | Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM). |
| Number of Participants With Severe Hypoglycemia (Per Protocol) | 13 weeks | Severe hypoglycemia (per protocol) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Artificial Pancreas First, Then Sensor-Augmented Pump/Predictive Low Glucose Suspend Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.
interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
After 13 weeks, participants then crossed over to the other arm. | 19 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM & glucometer at home for 13 weeks.
After 13 weeks, participants then crossed over to the other arm. | 16 |
| Total | 35 |
Baseline characteristics
| Characteristic | Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas | Total | Artificial Pancreas First, Then Sensor-Augmented Pump/Predictive Low Glucose Suspend |
|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 15 | 39 years STANDARD_DEVIATION 16 | 41 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 31 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 29 Participants | 19 Participants |
| Region of Enrollment United States | 16 participants | 35 participants | 19 participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 19 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 4 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 1 / 35 |
Outcome results
Primary
Non-inferiority for CGM Time <54 mg/dL
Superiority for time in range 70-180 mg/dL and non-inferiority for time \<54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Non-inferiority for CGM Time <54 mg/dL | 0.41 percentage of time | Standard Deviation 0.39 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Non-inferiority for CGM Time <54 mg/dL | 0.71 percentage of time | Standard Deviation 0.82 |
Primary
Percent CGM Time in Range 70-180 mg/dL
This results shown is mean percent time in range 70-180 mg/dL.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Percent CGM Time in Range 70-180 mg/dL | 69 percentage of time | Standard Deviation 14 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Percent CGM Time in Range 70-180 mg/dL | 66 percentage of time | Standard Deviation 14 |
Secondary
Basal: Bolus Insulin Ratio
Basal: bolus insulin ratio
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Artificial Pancreas | Basal: Bolus Insulin Ratio | 0.99 ratio |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Basal: Bolus Insulin Ratio | 1.13 ratio |
Secondary
CGM Mean Glucose
CGM-measured mean glucose (mg/dL)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Mean Glucose | 158 mg/dL | Standard Deviation 22 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Mean Glucose | 156 mg/dL | Standard Deviation 27 |
Secondary
CGM Time > 180
CGM time \> 180 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time > 180 | 29 percentage of time | Standard Deviation 15 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time > 180 | 30 percentage of time | Standard Deviation 16 |
Secondary
CGM Time > 250
CGM time \> 250 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time > 250 | 9 percentage of time | Standard Deviation 8 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time > 250 | 8 percentage of time | Standard Deviation 8 |
Secondary
CGM Time > 300
CGM time \> 300 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time > 300 | 3 percentage of time | Standard Deviation 4 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time > 300 | 3 percentage of time | Standard Deviation 4 |
Secondary
CGM Time < 54 (Superiority)
CGM time \< 54 mg/dL (Superiority)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time < 54 (Superiority) | 0.41 percentage of time | Standard Deviation 0.39 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time < 54 (Superiority) | 0.71 percentage of time | Standard Deviation 0.82 |
Secondary
CGM Time < 60
CGM time \< 60 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time < 60 | 0.81 percentage of time | Standard Deviation 0.73 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time < 60 | 1.39 percentage of time | Standard Deviation 1.45 |
Secondary
CGM Time < 70
CGM time \< 70 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time < 70 | 2.1 percentage of time | Standard Deviation 1.7 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time < 70 | 3.5 percentage of time | Standard Deviation 3.1 |
Secondary
CGM Time in Range 70-140 mg/dL
CGM-measured % in range 70-140 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | CGM Time in Range 70-140 mg/dL | 44 percentage of time | Standard Deviation 14 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | CGM Time in Range 70-140 mg/dL | 43 percentage of time | Standard Deviation 17 |
Secondary
Coefficient of Variation
CGM measured glucose variability measured with the coefficient of variation (CV)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Coefficient of Variation | 34.5 percentage SD of Mean | Standard Deviation 5.3 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Coefficient of Variation | 34.9 percentage SD of Mean | Standard Deviation 5.7 |
Secondary
Diabetes Distress Scale at 13 Weeks - Total Score
Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Diabetes Distress Scale at 13 Weeks - Total Score | 1.6 score on a scale | Standard Deviation 0.5 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Diabetes Distress Scale at 13 Weeks - Total Score | 1.6 score on a scale | Standard Deviation 0.5 |
Secondary
Glucose Monitoring Satisfaction Survey (Total Scale)
The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Glucose Monitoring Satisfaction Survey (Total Scale) | 3.9 score on a scale | Standard Deviation 0.8 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Glucose Monitoring Satisfaction Survey (Total Scale) | 4.0 score on a scale | Standard Deviation 0.6 |
Secondary
HbA1c at 13 Weeks
Hemiglobin A1c measured after completing each study arm
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | HbA1c at 13 Weeks | 6.8 percentage of glycated hemoglobin | Standard Deviation 0.8 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | HbA1c at 13 Weeks | 6.8 percentage of glycated hemoglobin | Standard Deviation 0.9 |
Secondary
HBGI
High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | HBGI | 6.8 index score | Standard Deviation 3.6 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | HBGI | 6.8 index score | Standard Deviation 4.1 |
Secondary
Hypoglycemia Confidence Scale
Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Hypoglycemia Confidence Scale | 3.4 score on a scale | Standard Deviation 0.5 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Hypoglycemia Confidence Scale | 3.5 score on a scale | Standard Deviation 0.5 |
Secondary
INSPIRE Survey Scores - Following Study System Period Only
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.
Time frame: 13 weeks
Population: following study system period only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | INSPIRE Survey Scores - Following Study System Period Only | 67.7 score on a scale | Standard Deviation 23.9 |
Secondary
LBGI
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 \< LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 \< LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI \> 5.0 is associated with high risk of hypoglycemia.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | LBGI | 0.6 index score | Standard Deviation 0.4 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | LBGI | 1.0 index score | Standard Deviation 0.8 |
Secondary
Number of Participants With HbA1c <7.0% at 13 Weeks
Number of participants HbA1c \<7.0% after completing each study arm
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Artificial Pancreas | Number of Participants With HbA1c <7.0% at 13 Weeks | 19 Participants |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Number of Participants With HbA1c <7.0% at 13 Weeks | 22 Participants |
Secondary
Number of Participants With HbA1c <7.5% at 13 Weeks
Number of participants HbA1c \<7.5% after completing each study arm
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Artificial Pancreas | Number of Participants With HbA1c <7.5% at 13 Weeks | 26 Participants |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Number of Participants With HbA1c <7.5% at 13 Weeks | 28 Participants |
Secondary
Standard Deviation
CGM measured glucose variability measured with the standard deviation (SD)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | Standard Deviation | 34.5 mg/dL | Standard Deviation 5.3 |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Standard Deviation | 34.9 mg/dL | Standard Deviation 5.7 |
Secondary
SUS Survey Scores - Following Study System Period
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Time frame: 13 weeks
Population: following study system period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Artificial Pancreas | SUS Survey Scores - Following Study System Period | 60.7 score on a scale | Standard Deviation 25.5 |
Secondary
Total Daily Insulin
Total Daily Insulin (units)
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Artificial Pancreas | Total Daily Insulin | 0.52 units/kg |
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Total Daily Insulin | 0.52 units/kg |
Other Pre-specified
Adverse Device Effects (ADE)
Adverse device effects (ADE)
Time frame: 13 weeks
Other Pre-specified
Any Adverse Event Rate Per 100 Person-years
For this outcome, the adverse event rate per 100 person-years calculated as a rate.
Time frame: 13 weeks
Other Pre-specified
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL
BG-measured Hypoglycemic Events (One BG Record \<54 mg/dL
Time frame: 13 weeks
Other Pre-specified
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
CGM-measured hyperglycemic events (\>15 minutes with glucose concentration \>300 mg/dL) in each arm.
Time frame: 3 months
Other Pre-specified
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
CGM-measured hypoglycemic events (\>15 minutes with glucose concentration \<54 mg/dL) in each arm.
Time frame: 3 months
Other Pre-specified
CGM Metrics by Time of Day
Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM).
Time frame: 13 weeks
Other Pre-specified
DKA Event Rate Per 100 Person-years
For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.
Time frame: 13 weeks
Other Pre-specified
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Ketone events defined as day with ketone level \>1.0 mmol/L
Time frame: 13 weeks
Other Pre-specified
Number of Participants With Diabetic Ketoacidosis (Per Protocol)
Diabetic ketoacidosis (per protocol)
Time frame: 13 weeks
Other Pre-specified
Number of Participants With DKA Events
For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.
Time frame: 13 weeks
Other Pre-specified
Number of Participants With Severe Hypoglycemia (Per Protocol)
Severe hypoglycemia (per protocol)
Time frame: 13 weeks
Other Pre-specified
Number of Participants With SH Events
For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group
Time frame: 13 weeks
Other Pre-specified
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)
Other serious adverse events (SAE) and serious adverse device events (SADE)
Time frame: 13 weeks
Other Pre-specified
SH Event Rate Per 100 Person-years
For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.
Time frame: 13 weeks
Other Pre-specified
Unanticipated Adverse Device Effects (UADE)
Unanticipated adverse device effects (UADE)
Time frame: 13 weeks
Other Pre-specified
Worsening of HbA1c From Baseline to 26 Weeks by >0.5%
Worsening of HbA1c from baseline to 26 weeks by \>0.5%
Time frame: 13 weeks