The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)

The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.

CGM-measured % above 180 mg/dL

CGM-measured mean glucose

CGM-measured % below 70 mg/dL

CGM-measured % below 54 mg/dL

CGM-measured % in range 70-140 mg/dL

CGM measured glucose variability measured with the coefficient of variation (CV)

CGM measured glucose variability measured with the standard deviation (SD)

CGM-measured % below 60 mg/dL

Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)

CGM-measured events of at least 15 consecutive minutes <70 mg/dL

CGM-measured % >250 mg/dL

CGM-measured % >300 mg/dL

High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)

HbA1c at 13 weeks.

HbA1c <7.0% at 13 weeks.

HbA1c <7.5% at 13 weeks.

HbA1c change from baseline to 13 weeks >0.5%.

HbA1c change from baseline to 13 weeks >1.0%.

HbA1c relative change from baseline to 13 weeks >10%.

HbA1c change from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks.

Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia.

Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses.The teen survey has a total of 25 items and the range of Total scores is 0 to 100.

Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.

Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.

Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.

Hypoglycemia Confidence Scale has 9 items which are self-rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.

Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)

The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.

The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Teens/Adolescents survey has 17 items.

The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Parent survey has 21 items.

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

Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.

Total Daily Insulin (units/kg)

Basal:Bolus Insulin Ratio.

Weight (kg)

Body Mass Index (BMI) kg/m2

Ketone events defined as day with ketone level > 1.0 mmol/L

CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL).

CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL).

Worsening of HbA1c from randomization to 13 weeks by >0.5%.

Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects).

Adverse device effects (ADE) that do not meet criteria for SAE.

Other serious adverse events not related to a study device.

Number of Severe Hypoglycemic events over initial 13 weeks of trial

Number of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial

Number of DKA events over initial 13 weeks of trial

Number of DKA events per 100 person-years over initial 13 weeks

Number of adverse events per 100 person-years over initial 13 weeks

CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12.

CGM-measured % above 180mg/dL from Months 4-12

CGM-measured mean glucose from Months 4-12

CGM-measured % below 70 mg/dL from Months 4-12

CGM-measured % time below 54mg/dL from Months 4-12

CGM-measured % time in range 70-140mg/dL from Months 4-12

CGM measured glucose variability measured with the coefficient of variation from Months 4-12

CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12

CGM-measured % below 60mg/dL from Months 4-12

LBGI from Months 4-12. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)

HBGI from Months 4-12. High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)

CGM-measured events of at least 15 consecutive minutes <70mg/dL from Months 4-12

CGM-measured % time >250 mg/dL from Months 4-12

CGM-measured % time >300 mg/dL from Months 4-12

HbA1c measured at Month 6 of this extension study

HbA1c measured at month 9 of this extension study

HbA1c measured at Month 12 of this extension study

Ketone Events Defined as Number of Days with at least one Ketone Level >1.0 mmol/L from Months 4-12

CGM-measured Hypoglycemia Events (>15 minutes with glucose concentration <54mg/dL) from Months 4-12 measured as a rate per week.

CGM-measured Hyperglycemic Events (>15 consecutive minutes with CGM glucose >300mg/dL) from Months 4-12

Number of Severe Hypoglycemic Events from Months 4-12.

Number of Diabetic Ketoacidosis (DKA) events from Months 4-12.

Other Serious Adverse Events Not Related to a Study Device from Months 4-12.

Any Adverse Event Rate per 100 person-years from Months 4-12.