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

The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.

CGM-measured % above 180 mg/dL

CGM-measured mean glucose

Hemoglobin A1c measured at 26 weeks

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 <70mg/dL per week

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)

Number of participants HbA1c <7.0% at 26 weeks

Number of Participants with HbA1c <7.5% at 26 weeks

HbA1c improvement from baseline to 26 weeks >0.5%

HbA1c improvement from baseline to 26 weeks >1.0%

HbA1c relative improvement from baseline to 26 weeks >10%

HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks

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. The teen survey has a total of 25 items and the range of Total scores is 0 to 100. 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 20 items which are 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 Teens/Adolescents survey has 17 items and the Parent survey has 21 items.

System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate 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)

Basal:Bolus Insulin Ratio

Weight (kg)

Body Mass Index (BMI) kg/m^2

Severe hypoglycemia (per protocol)

Diabetic ketoacidosis (per protocol)

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)

BG-measured hypoglycemic events (one BG record <54 mg/dL)

BG-measured hyperglycemic events (one BG record >350 mg/dL)

Worsening of HbA1c from baseline to 26 weeks by >0.5%

Other serious adverse events (SAE) and serious adverse device events (SADE)

Adverse device effects (ADE)

Unanticipated adverse device effects (UADE)

For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.

For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.

For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.

For this outcome, the adverse event rate per 100 person-years calculated as a rate.