Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes (T1D), Continuous Glucose Monitor (CGM), Insulin Pump, Fully Automated Closed Loop (FCL), Hybrid Closed Loop (HCL)
Brief summary
The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.
Detailed description
This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order; 1. without the meal anticipation module and without carbohydrate announcement (FCL) 2. with the meal anticipation module and without carbohydrate announcement (FCL+) 3. without the meal anticipation module and with carbohydrate announcement (HCL), This study will target completion of up to 36 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order.
Interventions
DEVICEFully Closed Loop (FCL)
Closed loop without a meal anticipation module without announced carbohydrate
DEVICEFully Closed Loop with meal anticipation module (FCL+)
Closed loop with a meal anticipation module and without announced carbohydrate
DEVICEHybrid Closed Loop (HCL)
Closed loop without a meal anticipation module with announced carbohydrate
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18.0 and ≤70 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin for at least six months 4. Currently using insulin pump for at least three months 5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 6. Access to internet and willingness to upload data during the study as needed 7. For females, not currently known to be pregnant or breastfeeding 8. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 9. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 10. Willingness to use the University of Virginia (UVa) closed-loop system throughout study admission 11. Willingness to use the insulin supplied by the study for the hotel stay, if not already using that preparation. Study insulin will be lispro (Humalog) or aspart (Novolog) 12. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals) 13. Willingness to eat at least 1g/kg of carbohydrate per day during the hotel admission 14. Willingness to reschedule if placed on oral steroids 15. An understanding and willingness to follow the protocol and signed informed consent 16. Willingness to commit to self-quarantine for at least 5 days before COVID-19 testing (If participant has received a full course of COVID-19 vaccine and data emerge suggesting significantly reduced transmissibility among those receiving that vaccine, this self-quarantine requirement can be waived.)
Exclusion criteria
1. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 3. Pregnancy or intent to become pregnant during the trial 4. Currently being treated for a seizure disorder 5. Planned surgery during study duration 6. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals) 7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 8. Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team 9. Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours | The 5 hour period following breakfast during the study admission | Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemia Events Overall | The 24 hour study admission from 4pm to 4pm | 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. |
| Time in Range (TIR) 70-180 mg/dL Overall | The 24 hour study admission from 4pm to 4pm | Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome. |
| Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours | The 5 hour period following dinner during the study admission | Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following dinner. Higher TIR is a positive outcome. |
| Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours | The 5 hour period following lunch during the study admission | 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. |
| Time Below Range (TBR) From Breakfast Time + 5 Hours | The 5 hour period following breakfast during the study admission | Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast. |
| Time Below Range (TBR) Overall | The 24 hour study admission from 4pm to 4pm | Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission. |
| Time Below Range (TBR) From Dinner Time + 5 Hours | The 5 hour period following dinner during the study admission | Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner. |
| Time Below Range (TBR) From Lunch Time + 5 Hours | The 5 hour period following lunch during the study admission | Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch. |
| Time Above Range (TAR) From Breakfast Time + 5 Hours | The 5 hour period following breakfast during the study admission | Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast. |
| Time Above Range (TAR) Overall | The 24 hour study admission from 4pm to 4pm | Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission. |
| Time Above Range (TAR) From Dinner Time + 5 Hours | The 5 hour period following dinner during the study admission | Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner. |
| Time Above Range (TAR) From Lunch Time + 5 Hours | The 5 hour period following lunch during the study admission | Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch. |
| Number of Hypoglycemia Events From Breakfast Time + 5 Hours | The 5 hour period following breakfast during the study admission | 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. |
| Time in Significant Hyperglycemia Overall | The 24 hour study admission from 4pm to 4pm | Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission. |
| Time in Significant Hyperglycemia From Dinner Time + 5 Hours | The 5 hour period following dinner during the study admission | Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner. |
| Time in Significant Hyperglycemia From Lunch Time + 5 Hours | The 5 hour period following lunch during the study admission | Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch. |
| Time in Significant Hypoglycemia From Breakfast Time +5 Hours | The 5 hour period following breakfast during the study admission | Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast. |
| Time in Significant Hypoglycemia Overall | The 24 hour study admission from 4pm to 4pm | Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission. |
| Time in Significant Hypoglycemia Dinner Time + 5 Hours | The 5 hour period following dinner during the study admission | Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner. |
| Time in Significant Hypoglycemia Lunch Time + 5 Hours | The 5 hour period following lunch during the study admission | Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch |
| Number of Hypoglycemia Events Dinner Time + 5 Hours | The 5 hour period following dinner during the study admission | 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 Lunch Time + 5 Hours | The 5 hour period following lunch during the study admission | 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). |
| Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast | The 7 hour period including the two hours before and the 5 hours after breakfast | Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation |
| Units of Insulin Injected (Units/kg) Overall | The 24 hour study admission from 4pm to 4pm | Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission. |
| Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner | The 7 hour period including the 2 hours before and 5 hours after dinner | Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation |
| Time in Significant Hyperglycemia From Breakfast Time + 5 Hours | The 5 hour period following breakfast during the study admission | Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast. |
Countries
United States
Participant flow
Recruitment details
50 participants signed informed consent between May 2021 and March 2022. Four did not pass screening and ten participants withdrew prior to randomization. Thirty-six were randomized and the trial was completed by 35 (97%) participants; one participant was excluded after randomization.
Pre-assignment details
A minimum of 14 days of CGM and pump information were required for analysis of baseline glycemic control, meal patterns, and insulin use. For participants already using a Dexcom G6, retrospective data prior to enrollment could be used. Participants not using a Dexcom G6 CGM were trained and sent equipment for a minimum 30 days of data prior to study admission. Participants were asked to keep daily meal records to determine the expected timing of breakfast and dinner for the admission.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Baseline characteristics of all study participants regardless of randomization. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 15.4 |
| Body mass index (BMI) | 28.6 kg/m^2 STANDARD_DEVIATION 5.3 |
| Diabetes duration (years) | 26 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HbA1c | 6.7 percentage of glycated hemoglobin STANDARD_DEVIATION 0.9 |
| Previous CGM users | 34 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 1 / 36 | 0 / 35 | 1 / 35 |
| serious Total, serious adverse events | 0 / 36 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.
Time frame: The 5 hour period following breakfast during the study admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours | 58 percentage of time | Standard Deviation 21 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours | 63 percentage of time | Standard Deviation 19 |
| HCL (Hybrid Closed Loop) | Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours | 75 percentage of time | Standard Deviation 23 |
Secondary
Number of Hypoglycemia Events Dinner Time + 5 Hours
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.
Time frame: The 5 hour period following dinner during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Number of Hypoglycemia Events Dinner Time + 5 Hours | 0 events per participant |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Number of Hypoglycemia Events Dinner Time + 5 Hours | 0 events per participant |
| HCL (Hybrid Closed Loop) | Number of Hypoglycemia Events Dinner Time + 5 Hours | 0 events per participant |
Secondary
Number of Hypoglycemia Events From Breakfast Time + 5 Hours
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.
Time frame: The 5 hour period following breakfast during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Number of Hypoglycemia Events From Breakfast Time + 5 Hours | 0 events per participant |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Number of Hypoglycemia Events From Breakfast Time + 5 Hours | 0 events per participant |
| HCL (Hybrid Closed Loop) | Number of Hypoglycemia Events From Breakfast Time + 5 Hours | 0 events per participant |
Secondary
Number of Hypoglycemia Events Lunch Time + 5 Hours
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).
Time frame: The 5 hour period following lunch during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Number of Hypoglycemia Events Lunch Time + 5 Hours | 0 events per participant |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Number of Hypoglycemia Events Lunch Time + 5 Hours | 0 events per participant |
| HCL (Hybrid Closed Loop) | Number of Hypoglycemia Events Lunch Time + 5 Hours | 0 events per participant |
Secondary
Number of Hypoglycemia Events Overall
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.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Number of Hypoglycemia Events Overall | 0 events per participant |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Number of Hypoglycemia Events Overall | 0 events per participant |
| HCL (Hybrid Closed Loop) | Number of Hypoglycemia Events Overall | 0 events per participant |
Secondary
Time Above Range (TAR) From Breakfast Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.
Time frame: The 5 hour period following breakfast during the study admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time Above Range (TAR) From Breakfast Time + 5 Hours | 39 percentage of time | Standard Deviation 21 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Above Range (TAR) From Breakfast Time + 5 Hours | 34 percentage of time | Standard Deviation 20 |
| HCL (Hybrid Closed Loop) | Time Above Range (TAR) From Breakfast Time + 5 Hours | 22 percentage of time | Standard Deviation 24 |
Secondary
Time Above Range (TAR) From Dinner Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.
Time frame: The 5 hour period following dinner during the study admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time Above Range (TAR) From Dinner Time + 5 Hours | 26 percentage of time | Standard Deviation 29 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Above Range (TAR) From Dinner Time + 5 Hours | 29 percentage of time | Standard Deviation 34 |
| HCL (Hybrid Closed Loop) | Time Above Range (TAR) From Dinner Time + 5 Hours | 9.6 percentage of time | Standard Deviation 20 |
Secondary
Time Above Range (TAR) From Lunch Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.
Time frame: The 5 hour period following lunch during the study admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time Above Range (TAR) From Lunch Time + 5 Hours | 33 percentage of time | Standard Deviation 28 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Above Range (TAR) From Lunch Time + 5 Hours | 38 percentage of time | Standard Deviation 29 |
| HCL (Hybrid Closed Loop) | Time Above Range (TAR) From Lunch Time + 5 Hours | 15 percentage of time | Standard Deviation 21 |
Secondary
Time Above Range (TAR) Overall
Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time Above Range (TAR) Overall | 20 percentage of time | Standard Deviation 11 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Above Range (TAR) Overall | 21 percentage of time | Standard Deviation 12 |
| HCL (Hybrid Closed Loop) | Time Above Range (TAR) Overall | 12 percentage of time | Standard Deviation 10 |
Secondary
Time Below Range (TBR) From Breakfast Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.
Time frame: The 5 hour period following breakfast during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time Below Range (TBR) From Breakfast Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Below Range (TBR) From Breakfast Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time Below Range (TBR) From Breakfast Time + 5 Hours | 0 percentage of time |
Secondary
Time Below Range (TBR) From Dinner Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.
Time frame: The 5 hour period following dinner during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time Below Range (TBR) From Dinner Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Below Range (TBR) From Dinner Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time Below Range (TBR) From Dinner Time + 5 Hours | 0 percentage of time |
Secondary
Time Below Range (TBR) From Lunch Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.
Time frame: The 5 hour period following lunch during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time Below Range (TBR) From Lunch Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Below Range (TBR) From Lunch Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time Below Range (TBR) From Lunch Time + 5 Hours | 0 percentage of time |
Secondary
Time Below Range (TBR) Overall
Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time Below Range (TBR) Overall | 1.4 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time Below Range (TBR) Overall | 0.3 percentage of time |
| HCL (Hybrid Closed Loop) | Time Below Range (TBR) Overall | 1.0 percentage of time |
Secondary
Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following dinner. Higher TIR is a positive outcome.
Time frame: The 5 hour period following dinner during the study admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours | 72 percentage of time | Standard Deviation 29 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours | 71 percentage of time | Standard Deviation 34 |
| HCL (Hybrid Closed Loop) | Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours | 88 percentage of time | Standard Deviation 20 |
Secondary
Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours
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.
Time frame: The 5 hour period following lunch during the study admission
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours | 65 percentage of time | Standard Deviation 28 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours | 61 percentage of time | Standard Deviation 29 |
| HCL (Hybrid Closed Loop) | Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours | 84 percentage of time | Standard Deviation 22 |
Secondary
Time in Range (TIR) 70-180 mg/dL Overall
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Time in Range (TIR) 70-180 mg/dL Overall | 77 percentage of time | Standard Deviation 11 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Range (TIR) 70-180 mg/dL Overall | 77 percentage of time | Standard Deviation 12 |
| HCL (Hybrid Closed Loop) | Time in Range (TIR) 70-180 mg/dL Overall | 86 percentage of time | Standard Deviation 10 |
Secondary
Time in Significant Hyperglycemia From Breakfast Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.
Time frame: The 5 hour period following breakfast during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hyperglycemia From Breakfast Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hyperglycemia From Breakfast Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hyperglycemia From Breakfast Time + 5 Hours | 0 percentage of time |
Secondary
Time in Significant Hyperglycemia From Dinner Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.
Time frame: The 5 hour period following dinner during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hyperglycemia From Dinner Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hyperglycemia From Dinner Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hyperglycemia From Dinner Time + 5 Hours | 0 percentage of time |
Secondary
Time in Significant Hyperglycemia From Lunch Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.
Time frame: The 5 hour period following lunch during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hyperglycemia From Lunch Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hyperglycemia From Lunch Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hyperglycemia From Lunch Time + 5 Hours | 0 percentage of time |
Secondary
Time in Significant Hyperglycemia Overall
Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hyperglycemia Overall | 1 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hyperglycemia Overall | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hyperglycemia Overall | 0 percentage of time |
Secondary
Time in Significant Hypoglycemia Dinner Time + 5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.
Time frame: The 5 hour period following dinner during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hypoglycemia Dinner Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hypoglycemia Dinner Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hypoglycemia Dinner Time + 5 Hours | 0 percentage of time |
Secondary
Time in Significant Hypoglycemia From Breakfast Time +5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.
Time frame: The 5 hour period following breakfast during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hypoglycemia From Breakfast Time +5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hypoglycemia From Breakfast Time +5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hypoglycemia From Breakfast Time +5 Hours | 0 percentage of time |
Secondary
Time in Significant Hypoglycemia Lunch Time + 5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch
Time frame: The 5 hour period following lunch during the study admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hypoglycemia Lunch Time + 5 Hours | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hypoglycemia Lunch Time + 5 Hours | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hypoglycemia Lunch Time + 5 Hours | 0 percentage of time |
Secondary
Time in Significant Hypoglycemia Overall
Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FCL (Fully Closed Loop) | Time in Significant Hypoglycemia Overall | 0 percentage of time |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Time in Significant Hypoglycemia Overall | 0 percentage of time |
| HCL (Hybrid Closed Loop) | Time in Significant Hypoglycemia Overall | 0 percentage of time |
Secondary
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast
Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation
Time frame: The 7 hour period including the two hours before and the 5 hours after breakfast
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast | 0.14 units of insulin / kg | Standard Deviation 0.05 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast | 0.14 units of insulin / kg | Standard Deviation 0.06 |
| HCL (Hybrid Closed Loop) | Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast | 0.18 units of insulin / kg | Standard Deviation 0.1 |
Secondary
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner
Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation
Time frame: The 7 hour period including the 2 hours before and 5 hours after dinner
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner | 0.02 units of insulin / kg | Standard Deviation 0.03 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner | 0.03 units of insulin / kg | Standard Deviation 0.02 |
| HCL (Hybrid Closed Loop) | Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner | 0.02 units of insulin / kg | Standard Deviation 0.02 |
Secondary
Units of Insulin Injected (Units/kg) Overall
Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.
Time frame: The 24 hour study admission from 4pm to 4pm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FCL (Fully Closed Loop) | Units of Insulin Injected (Units/kg) Overall | 0.5 units of insulin / kg | Standard Deviation 0.2 |
| FCL+ (Fully Closed Loop With Meal Anticipation) | Units of Insulin Injected (Units/kg) Overall | 0.5 units of insulin / kg | Standard Deviation 0.2 |
| HCL (Hybrid Closed Loop) | Units of Insulin Injected (Units/kg) Overall | 0.6 units of insulin / kg | Standard Deviation 0.25 |