Type 1 Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)
Detailed description
This is a 6 month, multi-center, randomized, parallel, adaptive study in type 1 diabetes with a 6 month continuation period. The study will have three periods, per Cohort: 1. Run-in Period: The run-in period can be up to 60 days during which time a blinded CGM sensor will be worn for two weeks. 2. Study Period: There will be a 6 month randomized study period with two arms: The HCL system and Control. The primary and secondary endpoints will be evaluated during this period only. 3. Continuation Period: There will be a 6 month continuation period during which time all subjects will use the HCL system with Auto Mode. Only the safety endpoint will be evaluated during this period. Up to 1500 subjects will be enrolled in order to have 1000 subjects complete the study. Up to 70 investigational Centers in the US, Europe, Canada, Australia and New Zealand will be enrolled.
Interventions
DEVICE670G and 770G Insulin Pump
Medtronic 670G and 770G Hybrid Closed Loop Systems
DEVICESubject's Current Diabetes Therapy
Subject will use current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump).
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There will be three cohorts sequentially enrolled for the study. Cohort 1: Continuous Subcutaneous Insulin Infusion (CSII cohort): randomized to HCL (treatment arm) or CSII (Control arm) Cohort 2: Multiple Daily Injections (MDI cohort): randomized to HCL (treatment arm) or MDI (Control arm) Cohort 3: Sensor-Augmented Pump therapy (SAP cohort): randomized to HCL (treatment arm) or SAP (Control arm) Note: Subjects 2-6 years of age will automatically enter the HCL arm at the end of the run-in period
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is age 2-80 years at time of screening 1. US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study. 2. Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study. 2. Subjects who are 2-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study 3. Subject must have a minimum daily insulin requirement (Total Daily Dose) of equal to or greater than 8 units/day 4. Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study 5. Subject has been diagnosed with type 1 diabetes for at least three months Note: Determination of classification for diabetes will be based on American Diabetes Association Clinical Practice Guidelines accounting for several patient characteristics such as: age of onset, patient's weight or BMI, history of diabetic ketoacidosis, history of therapy management, if available in the medical records. 6. Subject must be on one of the following management therapies: 1. Multiple daily injections defined by use of rapid analogue with meals and approved long acting analogue (e.g. detemir or glargine) with or without CGM 2. Insulin pump therapy with or without CGM 7. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily 8. Subject is willing to perform required study procedures 9. Subject is willing to wear the system continuously throughout the study for at least 80% of the time. 10. Subject is willing to upload data at least weekly from the study pump/meter, must have Internet access and a computer system that meets the requirements for uploading the study pump/meter for data collection 11. Subject must be willing to use the study glucose meter system (i.e. along with study meter strips). 12. If subject has celiac disease, it has been adequately treated as determined by the investigator 13. Subject with the diagnosis of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease, within 1 year of screening, will be included in the study with the consent of the Investigator 14. Subject is willing to take one of the following insulins and can financially afford to use either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount) 1. Humalog® (insulin lispro injection) 2. NovoLog® (insulin aspart)
Exclusion criteria
1. Subject participated in any Closed Loop study in the past. 2. Subject is unable to tolerate tape adhesive in the area of sensor placement 3. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) or area of infusion set placement 4. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study 5. Subject is being treated for hyperthyroidism at time of screening 6. Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. TSH is not required for subjects 2-13 years of age. 7. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. 8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks 9. Subject is currently abusing illicit drugs or marijuana 10. Subject is currently abusing prescription drugs 11. Subject is currently abusing alcohol 12. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas at time of screening 13. Subject is using hydroxyurea at the time of screening or plans to use it during the study 14. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator 15. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening 16. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation 17. Subject diagnosed with current moderate to severe eating disorder such as anorexia or bulimia 18. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia 19. Subjects who are currently being actively treated for cancer. 20. Subject who is designated as a research staff member for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C) | Baseline and end of 6-month study period | CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1C \> 8% |
| CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 6 months study period | CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8% |
| MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C) | Baseline and end of 6-month study period | MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c \> 8% |
| MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 6 months study period | MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8% |
| SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C) | Baseline and end of 6-month study period | SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c \> 8% |
| SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 6 months study period | SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSII Cohort: Change in A1C for All Subjects | Baseline and end of 6-month study period | CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects |
| MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 6 months study period | MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8% |
| MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | Baseline and end of 6-month study period | MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8% |
| MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects | 6 months study period | MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects |
| MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 6 months study period | MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects |
| MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 6 months study period | MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects |
| MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 6 months study period | MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects |
| CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 6 months study period | CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8% |
| SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 6 months study period | SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8% |
| SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | Baseline and end of 6-month study period | SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8% |
| SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects | 6 months study period | SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects |
| SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 6 months study period | SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects |
| SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 6 months study period | SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects |
| SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 6 months study period | SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects |
| SAP Cohort: Change in A1C for All Subjects | Baseline and end of 6-month study period | SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects |
| MDI Cohort: Change in A1C for All Subjects | Baseline and end of 6-month study period | MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects |
| CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | Baseline and end of 6-month study period | CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8% |
| CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects | 6 months study period | CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects |
| CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 6 months study period | CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects |
| CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 6 months study period | CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects |
| CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 6 months study period | CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects |
Countries
Canada, France, Germany, Italy, New Zealand, Spain, Sweden, United Kingdom, United States
Participant flow
Recruitment details
Date of first subject enrollment: 25MAY2017, Date of last subject visit (of study period): 09MAY2023 Date of last subject visit (of continuation period): 01NOV2023
Pre-assignment details
870 (298 in CSII Cohort, 248 in MDI Cohort, 324 in SAP Cohort) subjects entered the study period.
Participants by arm
| Arm | Count |
|---|---|
| CSII Cohort: Treatment Arm In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system. | 150 |
| CSII Cohort: Control Arm In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system. | 148 |
| MDI Cohort: Treatment Arm In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system. | 126 |
| MDI Cohort: Control Arm In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system. | 122 |
| SAP Cohort: Treatment Arm In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system. | 164 |
| SAP Cohort: Control Arm In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system. | 160 |
| Total | 870 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Continuation Period | Adverse Event | 2 | 0 | 1 | 1 | 1 | 4 |
| Continuation Period | Lost to Follow-up | 0 | 2 | 1 | 0 | 1 | 0 |
| Continuation Period | Physician Decision | 0 | 1 | 2 | 0 | 2 | 1 |
| Continuation Period | Pregnancy | 1 | 2 | 0 | 0 | 0 | 0 |
| Continuation Period | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 |
| Continuation Period | Withdrawal by Subject | 3 | 5 | 3 | 9 | 11 | 1 |
| Study Period | Adverse Event | 1 | 3 | 4 | 0 | 3 | 3 |
| Study Period | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 | 1 |
| Study Period | Physician Decision | 2 | 2 | 1 | 0 | 2 | 0 |
| Study Period | Pregnancy | 0 | 1 | 0 | 0 | 1 | 0 |
| Study Period | Withdrawal by Subject | 7 | 4 | 4 | 11 | 12 | 10 |
Baseline characteristics
| Characteristic | CSII Cohort: Treatment Arm | CSII Cohort: Control Arm | MDI Cohort: Treatment Arm | MDI Cohort: Control Arm | SAP Cohort: Treatment Arm | SAP Cohort: Control Arm | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.0 Years STANDARD_DEVIATION 19.8 | 35.1 Years STANDARD_DEVIATION 18.1 | 33.6 Years STANDARD_DEVIATION 19.6 | 37.9 Years STANDARD_DEVIATION 19.2 | 36.4 Years STANDARD_DEVIATION 21.3 | 39.2 Years STANDARD_DEVIATION 21.4 | 37.1 Years STANDARD_DEVIATION 20.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 4 Participants | 6 Participants | 16 Participants | 7 Participants | 4 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 141 Participants | 144 Participants | 109 Participants | 95 Participants | 154 Participants | 156 Participants | 799 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 11 Participants | 11 Participants | 3 Participants | 0 Participants | 26 Participants |
| Sex: Female, Male Female | 71 Participants | 90 Participants | 38 Participants | 42 Participants | 90 Participants | 83 Participants | 414 Participants |
| Sex: Female, Male Male | 79 Participants | 58 Participants | 88 Participants | 80 Participants | 74 Participants | 77 Participants | 456 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 148 | 0 / 126 | 0 / 122 | 0 / 164 | 0 / 160 | 0 / 796 |
| other Total, other adverse events | 80 / 150 | 86 / 148 | 72 / 126 | 77 / 122 | 94 / 164 | 101 / 160 | 395 / 796 |
| serious Total, serious adverse events | 1 / 150 | 4 / 148 | 3 / 126 | 2 / 122 | 4 / 164 | 6 / 160 | 26 / 796 |
Outcome results
Primary
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1C \> 8%
Time frame: Baseline and end of 6-month study period
Population: Study period: 298 subjects in CSII cohort. 147 subjects have available measurements in the baseline A1C \> 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C) | -1.6 Percentage of HbA1c | Standard Deviation 1.3 |
| CSII Cohort: Control Arm | CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C) | -0.8 Percentage of HbA1c | Standard Deviation 0.9 |
Primary
CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Time frame: 6 months study period
Population: Study period: 298 subjects in CSII cohort. 129 subjects have available measurements in the baseline A1C ≤ 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 2.4 Percentage of Time | Standard Deviation 1.9 |
| CSII Cohort: Control Arm | CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 7.3 Percentage of Time | Standard Deviation 5.3 |
Primary
MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c \> 8%
Time frame: Baseline and end of 6-month study period
Population: Study period: 248 subjects in MDI cohort. 94 subjects have available measurements in the baseline A1C \> 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C) | -1.4 Percentage of HbA1c | Standard Deviation 1.1 |
| CSII Cohort: Control Arm | MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C) | -0.6 Percentage of HbA1c | Standard Deviation 0.9 |
Primary
MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Time frame: 6 months study period
Population: Study period: 248 subjects in MDI cohort. 120 subjects have available measurements in the baseline A1C ≤ 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 2.8 Percentage of Time | Standard Deviation 2.7 |
| CSII Cohort: Control Arm | MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 7.5 Percentage of Time | Standard Deviation 6.1 |
Primary
SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c \> 8%
Time frame: Baseline and end of 6-month study period
Population: Study period: 324 subjects in SAP cohort. 108 subjects have available measurements in the baseline A1C \> 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C) | -0.6 Percentage of HbA1c | Standard Deviation 0.8 |
| CSII Cohort: Control Arm | SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C) | -0.6 Percentage of HbA1c | Standard Deviation 1 |
Primary
SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Time frame: 6 months study period
Population: Study period: 324 subjects in SAP cohort. 177 subjects have available measurements in the baseline A1c ≤ 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 2.5 Percentage of Time | Standard Deviation 2.3 |
| CSII Cohort: Control Arm | SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range | 3.5 Percentage of Time | Standard Deviation 3 |
Secondary
CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Time frame: Baseline and end of 6-month study period
Population: Study period: 298 subjects in CSII cohort. 131 subjects have available measurements in the baseline A1c ≤ 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | -0.4 Percentage of HbA1c | Standard Deviation 0.5 |
| CSII Cohort: Control Arm | CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | -0.0 Percentage of HbA1c | Standard Deviation 0.6 |
Secondary
CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8%
Time frame: 6 months study period
Population: Study period: 298 subjects in CSII cohort. 136 subjects have available measurements in the baseline A1c \> 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 2.3 Percentage of Time | Standard Deviation 2.3 |
| CSII Cohort: Control Arm | CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 4.6 Percentage of Time | Standard Deviation 5.2 |
Secondary
CSII Cohort: Change in A1C for All Subjects
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Time frame: Baseline and end of 6-month study period
Population: Study period: 298 subjects in CSII cohort. 278 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Change in A1C for All Subjects | -1.0 Percentage of HbA1c | Standard Deviation 1.2 |
| CSII Cohort: Control Arm | CSII Cohort: Change in A1C for All Subjects | -0.4 Percentage of HbA1c | Standard Deviation 0.9 |
Secondary
CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Time frame: 6 months study period
Population: Study period: 298 subjects in CSII cohort. 265 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 2.4 Percentage of Time | Standard Deviation 2.1 |
| CSII Cohort: Control Arm | CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 6.0 Percentage of Time | Standard Deviation 5.4 |
Secondary
CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Time frame: 6 months study period
Population: Study period: 298 subjects in CSII cohort. 264 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects | 2.3 Percentage of Time | Standard Deviation 3.3 |
| CSII Cohort: Control Arm | CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects | 7.7 Percentage of Time | Standard Deviation 9.4 |
Secondary
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Time frame: 6 months study period
Population: Study period: 298 subjects in CSII cohort. 265 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 67.4 Percentage of Time | Standard Deviation 10.8 |
| CSII Cohort: Control Arm | CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 55.4 Percentage of Time | Standard Deviation 15 |
Secondary
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Time frame: 6 months study period
Population: Study period: 298 subjects in CSII cohort. 264 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 73.8 Percentage of Time | Standard Deviation 14.3 |
| CSII Cohort: Control Arm | CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 55.0 Percentage of Time | Standard Deviation 20.8 |
Secondary
MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Time frame: Baseline and end of 6-month study period
Population: Study period: 248 subjects in MDI cohort. 130 subjects have available measurements in the baseline A1C ≤ 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | 0.0 Percentage of HbA1c | Standard Deviation 0.6 |
| CSII Cohort: Control Arm | MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | -0.1 Percentage of HbA1c | Standard Deviation 0.5 |
Secondary
MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8%
Time frame: 6 months study period
Population: Study period: 248 subjects in MDI cohort. 88 subjects have available measurements in the baseline A1C \> 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 1.9 Percentage of Time | Standard Deviation 1.6 |
| CSII Cohort: Control Arm | MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 5.5 Percentage of Time | Standard Deviation 5.9 |
Secondary
MDI Cohort: Change in A1C for All Subjects
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Time frame: Baseline and end of 6-month study period
Population: Study period: 248 subjects in MDI cohort. 224 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Change in A1C for All Subjects | -0.6 Percentage of HbA1c | Standard Deviation 1.1 |
| CSII Cohort: Control Arm | MDI Cohort: Change in A1C for All Subjects | -0.3 Percentage of HbA1c | Standard Deviation 0.8 |
Secondary
MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Time frame: 6 months study period
Population: Study period: 248 subjects in MDI cohort. 208 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 2.4 Percentage of Time | Standard Deviation 2.3 |
| CSII Cohort: Control Arm | MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 6.7 Percentage of Time | Standard Deviation 6 |
Secondary
MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Time frame: 6 months study period
Population: Study period: 248 subjects in MDI cohort. 206 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects | 1.9 Percentage of Time | Standard Deviation 2.6 |
| CSII Cohort: Control Arm | MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects | 9.2 Percentage of Time | Standard Deviation 14.1 |
Secondary
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Time frame: 6 months study period
Population: Study period: 248 subjects in MDI cohort. 208 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 70.6 Percentage of Time | Standard Deviation 11.3 |
| CSII Cohort: Control Arm | MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 57.0 Percentage of Time | Standard Deviation 15.6 |
Secondary
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Time frame: 6 months study period
Population: Study period: 248 subjects in MDI cohort. 206 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 75.9 Percentage of Time | Standard Deviation 13.6 |
| CSII Cohort: Control Arm | MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 60.0 Percentage of Time | Standard Deviation 21 |
Secondary
SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Time frame: Baseline and end of 6-month study period
Population: Study period: 324 subjects in SAP cohort. 184 subjects have available measurements in the baseline A1c ≤ 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | 0.0 Percentage of HbA1c | Standard Deviation 0.5 |
| CSII Cohort: Control Arm | SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C) | 0.1 Percentage of HbA1c | Standard Deviation 0.5 |
Secondary
SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8%
Time frame: 6 months study period
Population: Study period: 324 subjects in SAP cohort. 106 subjects have available measurements in the A1C \> 8% group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 2.5 Percentage of Time | Standard Deviation 1.9 |
| CSII Cohort: Control Arm | SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range | 2.8 Percentage of Time | Standard Deviation 3 |
Secondary
SAP Cohort: Change in A1C for All Subjects
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Time frame: Baseline and end of 6-month study period
Population: Study period: 324 subjects in SAP cohort. 292 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Change in A1C for All Subjects | -0.2 Percentage of HbA1c | Standard Deviation 0.7 |
| CSII Cohort: Control Arm | SAP Cohort: Change in A1C for All Subjects | -0.2 Percentage of HbA1c | Standard Deviation 0.8 |
Secondary
SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Time frame: 6 months study period
Population: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 2.5 Percentage of Time | Standard Deviation 2.2 |
| CSII Cohort: Control Arm | SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects | 3.3 Percentage of Time | Standard Deviation 3 |
Secondary
SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Time frame: 6 months study period
Population: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects | 2.5 Percentage of Time | Standard Deviation 3.4 |
| CSII Cohort: Control Arm | SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects | 3.2 Percentage of Time | Standard Deviation 4.4 |
Secondary
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Time frame: 6 months study period
Population: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 65.7 Percentage of Time | Standard Deviation 12.4 |
| CSII Cohort: Control Arm | SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects | 59.4 Percentage of Time | Standard Deviation 14 |
Secondary
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Time frame: 6 months study period
Population: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CSII Cohort: Treatment Arm | SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 73.2 Percentage of Time | Standard Deviation 15.4 |
| CSII Cohort: Control Arm | SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects | 61.0 Percentage of Time | Standard Deviation 18.4 |