Closed loop with a meal anticipation module and without announced carbohydrate

Closed loop without a meal anticipation module with announced carbohydrate

Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following lunch. Higher TIR is a positive outcome.

Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.

Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.

Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.

Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.

Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.

Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.

Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.

Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.

Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.

Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.

Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.

Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.

Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.

Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.

Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.

Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch

Number of hypoglycemia events in the 5 hours following breakfast. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Metrics are number of hypoglycemia events per participant.

Number of hypoglycemia events during the 24hr study admission. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.

Number of hypoglycemia events in the 5 hours following dinner. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.

Number of hypoglycemia events in the 5 hours following lunch. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one).

Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation

Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.

Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation

Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order.

The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken).

At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes.

Participants in this group completed the three 24 hour admissions in the following order: FCL, HCL, FCL+.

Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus.

Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order.

The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken).

At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes.

Participants in this group completed the three 24 hour admissions in the following order: FCL+, FCL, HCL.

Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus.

Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order.

The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken).

At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes.

Participants in this group completed the three 24 hour admissions in the following order: FCL+, HCL, FCL.

Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus.

Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order.

The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken).

At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes.

Participants in this group completed the three 24 hour admissions in the following order: HCL, FCL, FCL+.

Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus.

Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order.

The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken).

At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes.

Participants in this group completed the three 24 hour admissions in the following order: HCL, FCL+, FCL.

Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus.