A Study of t:Slim X2 With Control-IQ Technology

The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.

Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be somewhat dangerous due to the possibility of unconsciousness and death at low blood sugar values. Thus, less time spent below 70mg/dL is considered a positive outcome.

GM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.

CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16 week visit at the end of the main study up through the 28th week visit. If a participant drops out before completing the 28-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Smaller percentages of CGM-measured percentages of time above 180 mg/dL is considered a positive outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.

Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be undesirable. Thus, less time spent below 70mg/dL is considered a positive outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, time below 54 mg/dL suggests that the person may have been close to danger.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values above 250 mg/dL are considered to be undesireable. Thus, less time spent above 250mg/dL is considered a positive outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week trial extension period starting from 16 week visit to week 28 visit. If a participant drops out before completing the 32-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the study group. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM-Measured percent of time in blood sugar range 70-140 mg/dL. Larger percentages of time spent in this range is considered to be a desirable outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Standard Deviation represents how much glucose levels fluctuate over time from a given average.

CGM measured blood sugar values below 60 mg/dL are considered to be undesirable. Thus, less time spent below 60mg/dL is considered a positive outcome

Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar.

A Hypoglycemic event was defined as at least 15 consecutive minutes where the CGM was lower than 70mg/dL. Fewer hypoglycemia events are considered better.

CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome

Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit (end of study). If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar.

This is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 5% in the percentage of time they were in the safe blood sugar range of 70-180 mg/dL. More participants (a greater percentage of participants) improving by this much is considered positive.

This is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 10% in the percentage of time they were in the ideal blood sugar range of 70-140 mg/dL. More participants (a greater percentage of participants) improving this much is considered positive

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 0.5% or greater are considered clinically significant improvements.

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements.

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements, HbA1c values less than 7.0 are considered better for long-term health.

The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly.

The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia. Parents and children took the questionnaire independently.

The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11.

The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon >200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems.

This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems

Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability

Total Daily Insulin (Units/kg/day) over 16 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days.

Insulin metrics were calculated at randomization and 16 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day.

Participant Weight in kg measured at 16 weeks

The primary outcome for the extension phase is improving the percent of time in the blood sugar range 70-180 mg/dL over the 12 weeks of the extension phase of the study

CGM-Measured percent of time in blood sugar range 70-140 mg/dL over the 12 week extension study. Larger percentages of time spent in this range is considered to be a desireable outcome.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.

Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.

Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar.

CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16th week of the main trial through the 12th week of the extension. If a participant drops out before completing the 12-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value below 54 mg/dL. Fewer glycemic events per week is considered a better outcome.

CGM measured blood sugar values above 300 mg/dL are considered to be undesireable. Thus, less time spent above 300mg/dL is considered a positive outcome

Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar.

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome.

HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome.

The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly.

The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia.

The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11.

The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon >200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems.

This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems.

Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability.

Total Daily Insulin (Units/kg/day) over 12 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days.

Insulin metrics were calculated at 16 weeks and 28 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day.

Body Mass Index (BMI) is a calculation of participant body weight in kilograms and height in centimeters. The z-score was calculated from values taken at the end of the 28 weeks of the study. Z-score of zero represents the US population mean for their age and sex group. Positive Z scores indicate higher body mass index values than the population mean, which is generally considered undesirable