Type 1 Diabetes
Conditions
Keywords
Control-IQ, type 1 diabetes, t:slim X2
Brief summary
A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate \> 3 units/hr.
Detailed description
The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate \> 3 units/hr. Up to 60 participants may be recruited.
Interventions
t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.
Sponsors
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of type 1 diabetes for at least 1 year * Currently using an insulin pump (of any brand) for at least 3 months, and will plan to use at least one basal rate above 3 units/hr with the study pump * HbA1c \< 10.5% * Weight ≤ 200 kg * Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation. * Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF); and has agreed to follow all study procedures, including suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use. * Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin with the study pump. * Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) * Willing and able to perform the study exercise and meal challenges. * Have a care partner, trained in hypoglycemia and hyperglycemia treatment guidelines, present during the challenges and until the next day. * Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.
Exclusion criteria
* More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months * More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months * Inpatient psychiatric treatment in the past 6 months * History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study. * For Female: Currently pregnant or planning to become pregnant during the time period of study participation * Use of sulfonylureas, meglitinides or other medications specifically listed in protocol or determined by investigator to interfere with the study * Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or DPP-4 inhibitor as listed in the protocol, or starting a new non-insulin glucose lowering or weight loss agent during the trial * Hemophilia or any other bleeding disorder * History of heart, liver, lung or kidney disease determined by investigator to interfere with the study * History of allergic reaction to Humalog or Novolog * Use of glucocorticoids or other medications determined by investigator to interfere with study * Abnormal screening electrocardiogram consistent with increased risk during study exercise activities, such as arrhythmia, ischemia, or prolonged QTc interval. Investigator will review all electrocardiograms * Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis * History of adrenal insufficiency * History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated * History of gastroparesis * A condition, which in the opinion of the investigator or designee, would put the participant or study at risk * Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation * Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe Hypoglycemic Events | 3 months | Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period |
| Number of Diabetic Ketoacidosis Events | 3 months | Number of diabetic ketoacidosis events during the entire study period |
| Unanticipated Adverse Device Effects | 3 months | Number of unanticipated adverse device effects during the entire study period |
| Other Serious Adverse Events | 3 months | Number of serious adverse events during the entire study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Time <70 mg/dL Daytime Only | 3 months | Percent time CGM glucose \<70 mg/dL daytime only (06:00 - 24:00) |
| CGM Time <54 mg/dL Overall | 3 months | Percent time CGM glucose \<54 mg/dL overall |
| CGM Time <70 mg/dL Nighttime Only | 3 months | Percent time CGM glucose \<70 mg/dL nighttime only (00:00 - 06:00) |
| CGM Time <54 mg/dL Daytime Only | 3 months | Percent time CGM glucose \<54 mg/dL daytime only (06:00 - 24:00) |
| CGM Time <54 mg/dL Nighttime Only | 3 months | Percent time CGM glucose \<54 mg/dL nighttime only (00:00 - 06:00) |
| CGM Time <70 mg/dL Overall | 3 months | Percent time CGM glucose \<70 mg/dL overall |
Other
| Measure | Time frame | Description |
|---|---|---|
| CGM Time in Range 70-140 mg/dL Overall | 3 months | Percent time CGM glucose in range 70-140 mg/dl overall |
| CGM Time in Range 70-140 mg/dL Daytime Only | 3 months | Percent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00) |
| CGM Time in Range 70-140 mg/dL Nighttime Only | 3 months | Percent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00) |
| CGM Mean Glucose mg/dL Overall | 3 months | CGM-measured mean glucose (mg/dL) overall |
| CGM Mean Glucose mg/dL Daytime Only | 3 months | CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00) |
| CGM Mean Glucose mg/dL Nighttime Only | 3 months | CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00) |
| Hemoglobin A1c | 3 months | Change in Hemoglobin A1c from baseline |
| Coefficient of Variation Daytime Only | 3 months | CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00) |
| Coefficient of Variation Nighttime Only | 3 months | CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00) |
| Standard Deviation of Glucose, Overall | 3 months | CGM measured standard deviation of glucose (mg/dL) overall |
| Standard Deviation of Glucose, Daytime | 3 months | CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00) |
| Standard Deviation of Glucose, Nighttime Only | 3 months | CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00) |
| Coefficient of Variation Overall | 3 months | CGM measured glucose variability measured with the coefficient of variation overall |
| CGM Time in Range 70-180 mg/dL Overall | 3 months | Percent time CGM glucose in range 70-180 mg/dl overall |
| CGM Time in Range 70-180 mg/dL Daytime Only | 3 months | Percent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00) |
| CGM Time in Range 70-180 mg/dL Nighttime Only | 3 months | Percent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00) |
| CGM Time >180 mg/dL Overall | 3 months | Percent time CGM glucose\> 180 mg/dL overall |
| CGM Time >180 mg/dL Daytime Only | 3 months | Percent time CGM glucose\> 180 mg/dL daytime only (06:00 - 24:00) |
| CGM Time >180 mg/dL Nighttime Only | 3 months | Percent time CGM glucose\> 180 mg/dL nighttime only (00:00 - 06:00) |
| CGM Time >250 mg/dL Overall | 3 months | Percent time CGM glucose \>250 mg/dL overall |
| CGM Time >250 mg/dL Daytime Only | 3 months | Percent time CGM glucose \>250 mg/dL daytime only (06:00 - 24:00) |
| CGM Time >250 mg/dL Nighttime Only | 3 months | Percent time CGM glucose \>250 mg/dL nighttime only (00:00 - 06:00) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
t:slim X2 insulin pump with Control-IQ technology 1.5: t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | t:Slim X2 Insulin Pump With Control-IQ Technology |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 39.9 years |
| BMI | 37.6 kg/m^2 STANDARD_DEVIATION 5.2 |
| Duration of Diabetes | 21.8 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HbA1c at Control-IQ Start | 7.7 percentage of glycated hemoglobin STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 20 Participants |
| Socio-economic factors (education) Associate degree (AA) | 3 participants |
| Socio-economic factors (education) Bachelor's degree (BA, BS, AB) | 13 participants |
| Socio-economic factors (education) Doctorate degree (PhD, EdD) | 0 participants |
| Socio-economic factors (education) Does not wish to provide | 0 participants |
| Socio-economic factors (education) High school graduate / diploma / GED | 4 participants |
| Socio-economic factors (education) Less than high school | 1 participants |
| Socio-economic factors (education) Master's degree (MA, MS, MSW, MBA, MPH) | 5 participants |
| Socio-economic factors (education) Professional degree (MD, DDS, DVM, LLB, JD) | 0 participants |
| Socio-economic factors (education) Some college but no degree | 8 participants |
| Socio-economic factors (education) Unknown | 0 participants |
| Socio-economic factors (income) $100,000 to less than $200,000 | 11 participants |
| Socio-economic factors (income) $200,000 or more | 3 participants |
| Socio-economic factors (income) $25,000 to less than $35,000 | 0 participants |
| Socio-economic factors (income) $35,000 to less than $50,000 | 3 participants |
| Socio-economic factors (income) $50,000 to less than $75,000 | 1 participants |
| Socio-economic factors (income) $75,000 to less than $100,000 | 8 participants |
| Socio-economic factors (income) Less than $25,000 | 3 participants |
| Socio-economic factors (income) Unknown | 5 participants |
| Total daily insulin | 1.2 units/kg/day STANDARD_DEVIATION 0.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 19 / 34 |
| serious Total, serious adverse events | 1 / 34 |
Outcome results
Primary
Number of Diabetic Ketoacidosis Events
Number of diabetic ketoacidosis events during the entire study period
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Number of Diabetic Ketoacidosis Events | 0 events |
Primary
Number of Severe Hypoglycemic Events
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Number of Severe Hypoglycemic Events | 0 events |
Primary
Other Serious Adverse Events
Number of serious adverse events during the entire study period
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Other Serious Adverse Events | 1 events |
Primary
Unanticipated Adverse Device Effects
Number of unanticipated adverse device effects during the entire study period
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Unanticipated Adverse Device Effects | 0 events |
Secondary
CGM Time <54 mg/dL Daytime Only
Percent time CGM glucose \<54 mg/dL daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time <54 mg/dL Daytime Only | 0.2 percentage of time | Standard Deviation 0.2 |
Secondary
CGM Time <54 mg/dL Nighttime Only
Percent time CGM glucose \<54 mg/dL nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time <54 mg/dL Nighttime Only | 0.4 percentage of time | Standard Deviation 0.4 |
Secondary
CGM Time <54 mg/dL Overall
Percent time CGM glucose \<54 mg/dL overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time <54 mg/dL Overall | 0.2 percentage of time | Standard Deviation 0.2 |
Secondary
CGM Time <70 mg/dL Daytime Only
Percent time CGM glucose \<70 mg/dL daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time <70 mg/dL Daytime Only | 0.9 percentage of time | Standard Deviation 0.9 |
Secondary
CGM Time <70 mg/dL Nighttime Only
Percent time CGM glucose \<70 mg/dL nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time <70 mg/dL Nighttime Only | 1.4 percentage of time | Standard Deviation 1.5 |
Secondary
CGM Time <70 mg/dL Overall
Percent time CGM glucose \<70 mg/dL overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time <70 mg/dL Overall | 1.0 percentage of time | Standard Deviation 1 |
Other Pre-specified
CGM Mean Glucose mg/dL Daytime Only
CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Mean Glucose mg/dL Daytime Only | 168.8 mg/dL | Standard Deviation 17.3 |
Other Pre-specified
CGM Mean Glucose mg/dL Nighttime Only
CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Mean Glucose mg/dL Nighttime Only | 163.1 mg/dL | Standard Deviation 25.1 |
Other Pre-specified
CGM Mean Glucose mg/dL Overall
CGM-measured mean glucose (mg/dL) overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Mean Glucose mg/dL Overall | 167.4 mg/dL | Standard Deviation 17.7 |
Other Pre-specified
CGM Time >180 mg/dL Daytime Only
Percent time CGM glucose\> 180 mg/dL daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time >180 mg/dL Daytime Only | 35.6 percentage of time | Standard Deviation 11.3 |
Other Pre-specified
CGM Time >180 mg/dL Nighttime Only
Percent time CGM glucose\> 180 mg/dL nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time >180 mg/dL Nighttime Only | 30.1 percentage of time | Standard Deviation 15.1 |
Other Pre-specified
CGM Time >180 mg/dL Overall
Percent time CGM glucose\> 180 mg/dL overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time >180 mg/dL Overall | 34.2 percentage of time | Standard Deviation 11.1 |
Other Pre-specified
CGM Time >250 mg/dL Daytime Only
Percent time CGM glucose \>250 mg/dL daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time >250 mg/dL Daytime Only | 10.7 percentage of time | Standard Deviation 6.3 |
Other Pre-specified
CGM Time >250 mg/dL Nighttime Only
Percent time CGM glucose \>250 mg/dL nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time >250 mg/dL Nighttime Only | 9.6 percentage of time | Standard Deviation 10.4 |
Other Pre-specified
CGM Time >250 mg/dL Overall
Percent time CGM glucose \>250 mg/dL overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time >250 mg/dL Overall | 10.5 percentage of time | Standard Deviation 6.8 |
Other Pre-specified
CGM Time in Range 70-140 mg/dL Daytime Only
Percent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time in Range 70-140 mg/dL Daytime Only | 37.0 percentage of time | Standard Deviation 10.8 |
Other Pre-specified
CGM Time in Range 70-140 mg/dL Nighttime Only
Percent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time in Range 70-140 mg/dL Nighttime Only | 40.6 percentage of time | Standard Deviation 14.4 |
Other Pre-specified
CGM Time in Range 70-140 mg/dL Overall
Percent time CGM glucose in range 70-140 mg/dl overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time in Range 70-140 mg/dL Overall | 37.9 percentage of time | Standard Deviation 10.8 |
Other Pre-specified
CGM Time in Range 70-180 mg/dL Daytime Only
Percent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time in Range 70-180 mg/dL Daytime Only | 63.5 percentage of time | Standard Deviation 10.9 |
Other Pre-specified
CGM Time in Range 70-180 mg/dL Nighttime Only
Percent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time in Range 70-180 mg/dL Nighttime Only | 68.5 percentage of time | Standard Deviation 14.8 |
Other Pre-specified
CGM Time in Range 70-180 mg/dL Overall
Percent time CGM glucose in range 70-180 mg/dl overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | CGM Time in Range 70-180 mg/dL Overall | 64.8 percentage of time | Standard Deviation 10.8 |
Other Pre-specified
Coefficient of Variation Daytime Only
CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Coefficient of Variation Daytime Only | 34.4 percentage of coefficient of variation | Standard Deviation 4.6 |
Other Pre-specified
Coefficient of Variation Nighttime Only
CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Coefficient of Variation Nighttime Only | 33.7 percentage of coefficient of variation | Standard Deviation 6.4 |
Other Pre-specified
Coefficient of Variation Overall
CGM measured glucose variability measured with the coefficient of variation overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Coefficient of Variation Overall | 34.7 percentage of coefficient of variation | Standard Deviation 5.1 |
Other Pre-specified
Hemoglobin A1c
Change in Hemoglobin A1c from baseline
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Hemoglobin A1c | -0.82 percentage of glycated hemoglobin | Standard Deviation 0.73 |
Comparison: End of Control-IQ Use (13 Weeks) compared to Control-IQ Startp-value: <0.001t-test, 2 sided
Other Pre-specified
Standard Deviation of Glucose, Daytime
CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Standard Deviation of Glucose, Daytime | 58.4 mg/dL | Standard Deviation 11 |
Other Pre-specified
Standard Deviation of Glucose, Nighttime Only
CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Standard Deviation of Glucose, Nighttime Only | 55.1 mg/dL | Standard Deviation 14.3 |
Other Pre-specified
Standard Deviation of Glucose, Overall
CGM measured standard deviation of glucose (mg/dL) overall
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| t:Slim X2 Insulin Pump With Control-IQ Technology | Standard Deviation of Glucose, Overall | 58.2 mg/dL | Standard Deviation 11.7 |