Trial Outcomes & Findings for Fuzzy Logic Automated Insulin Regulation (NCT NCT03040414)

NCT ID: NCT03040414

Last Updated: 2021-04-20

Results Overview

Glucose levels based on sensor glucose data

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 126 participants
• Primary outcome timeframe: 12 weeks for each arm of the crossover
• Results posted on: 2021-04-20

Participant Flow

13 participants were not randomized from the 126 enrolled due to ineligibility or lost to follow up.

Participant milestones

Measure	PID Algorithm First, Then PID + Fuzzy Logic Algorithm Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm First, Then PID Algorithm Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Overall Study STARTED	57	56
Overall Study Completed Period 1	56	55
Overall Study Started Period 2	56	55
Overall Study COMPLETED	56	55
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fuzzy Logic Automated Insulin Regulation

Baseline characteristics by cohort

Measure	PID Algorithm First, Then PID + Fuzzy Logic Algorithm n=57 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm First, Then PID Algorithm n=56 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).	Total n=113 Participants Total of all reporting groups
Age, Continuous	20 years STANDARD_DEVIATION 4 • n=5 Participants	19 years STANDARD_DEVIATION 4 • n=7 Participants	19 years STANDARD_DEVIATION 4 • n=5 Participants
Sex/Gender, Customized Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex/Gender, Customized Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized White	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Race/Ethnicity, Customized Black/ African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized More than One Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Glucose levels based on sensor glucose data

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Percentage of Time Glucose Levels Were > 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM	37 percentage of time Standard Deviation 9	34 percentage of time Standard Deviation 9

PRIMARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Glucose levels based on sensor glucose data

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Non-inferiority for Percent of Time <54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period.	.50 percentage of time Standard Deviation .35	.46 percentage of time Standard Deviation .33

SECONDARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Continuous Glucose Monitoring derived indices over the first 84 days of each treatment period for 24 hours (excluding time before auto mode is turned on). Glucose levels based on sensor glucose data for Mean glucose.

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Efficacy: CGM Derived Indices: Mean Glucose Only	166 mg/dL Standard Deviation 13	159 mg/dL Standard Deviation 13

SECONDARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

CGM derived indices over the first 84 days of each treatment period for 24 hours. Glucose levels based on sensor glucose data for coefficient of variation; percentage of sensor glucose readings in the range of 70 to 180 mg/dL (3.9-10.0 mmol/L) and 70 to 140 mg/dL (3.9 to 7.8 mmol/L); percentage of sensor glucose readings >180 mg/dL (daytime is a co-primary outcome) and >250 mg/dL (10.0 and 13.9 mmol/L, respectively)

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Efficacy: CGM Derived Indices Percentage of Sensor Glucose Readings in the Range of 70-180 mg/dL (3·9-10·0 mmol/L)	63 percentage of sensor glucose readings Standard Deviation 8	67 percentage of sensor glucose readings Standard Deviation 8
Efficacy: CGM Derived Indices Percentage of Sensor Glucose Readings in the Range of 70 to 140 mg/dL (3.9 to 7.8 mmol/L)	40 percentage of sensor glucose readings Standard Deviation 7	44 percentage of sensor glucose readings Standard Deviation 7
Efficacy: CGM Derived Indices Percentage of Sensor Glucose Readings >180 mg/dL (10.0 mmol/L)	34 percentage of sensor glucose readings Standard Deviation 8	31 percentage of sensor glucose readings Standard Deviation 8
Efficacy: CGM Derived Indices Percentage of Sensor Glucose Readings >250 mg/dL (13.9 mmol/L)	10 percentage of sensor glucose readings Standard Deviation 6	9 percentage of sensor glucose readings Standard Deviation 5

SECONDARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Amount of total, basal, and bolus daily insulin over the first 84 days of each treatment period (excluding time before auto mode is turned on) for 24 hours. Glucose levels based on sensor glucose data. Sum of daytime and nighttime values may not equal total daily values due to rounding.

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Insulin Units for 24 Hours	50 insulin units Standard Deviation 21	55 insulin units Standard Deviation 22
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Insulin Units for Daytime	42 insulin units Standard Deviation 18	47 insulin units Standard Deviation 18
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Insulin Units for Nighttime	8 insulin units Standard Deviation 4	10 insulin units Standard Deviation 4
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Basal Insulin Units for 24 Hours	25 insulin units Standard Deviation 11	20 insulin units Standard Deviation 8
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Basal Insulin Units for Daytime	19 insulin units Standard Deviation 9	14 insulin units Standard Deviation 6
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Basal Insulin Units for Nighttime	7 insulin units Standard Deviation 3	6 insulin units Standard Deviation 2
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Bolus Insulin Units for 24 Hours	25 insulin units Standard Deviation 12	36 insulin units Standard Deviation 15
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Bolus Insulin Units for Daytime	24 insulin units Standard Deviation 11	32 insulin units Standard Deviation 13
Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period Total Bolus Insulin Units for Nighttime	1 insulin units Standard Deviation 2	4 insulin units Standard Deviation 3

SECONDARY outcome

Timeframe: Time Frame: End of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Glycated hemoglobin (HbA1c) was measured at a central laboratory (Advanced Research and Diagnostic Laboratory University of Minnesota, MN, USA) at randomization and at the end of each period by use of an International Federation of Clinical Chemistry and Laboratory Medicine aligned method (Tosoh HPLC Glycohemoglobin Analyzer, Tosoh Medics, San Francisco, CA, USA; coefficient of variation range 1.4 1.9%).

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Efficacy: HbA1c	7.6 percentage of HbA1c Standard Deviation 0.6	7.4 percentage of HbA1c Standard Deviation 0.8

SECONDARY outcome

Timeframe: Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both were included in the analysis for the partial period they completed. An additional two participants from the PID Algorithm group and an additional three participants from the PID + Fuzzy Logic Algorithm group were not included in this outcome due to missing data. Separate BMI outcomes were reported for participants age ≥18 years and age \<18 years due to differing units of measure.

Height and weight. Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.

Outcome measures

Measure	PID Algorithm n=66 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=66 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Efficacy: BMI for Participants Age ≥18 Years Body Mass Index (Age ≥18 years) End of Period 1	26 kg/m^2 Standard Deviation 5	27 kg/m^2 Standard Deviation 5
Efficacy: BMI for Participants Age ≥18 Years Body Mass Index (Age ≥18 years) End of Period 2	27 kg/m^2 Standard Deviation 5	26 kg/m^2 Standard Deviation 5

SECONDARY outcome

Timeframe: Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both were included in the analysis for the partial period they completed. An additional two participants from the PID Algorithm group and an additional three participants from the PID + Fuzzy Logic Algorithm group were not included in this outcome due to missing data. Separate BMI outcomes were reported for participants age ≥18 years and age \<18 years due to differing units of measure.

Height and weight based on CDC standards of measurement. Age and gender adjusted.

Outcome measures

Measure	PID Algorithm n=44 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=43 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Efficacy: BMI Percentile for Participants Age <18 Years Body Mass Index Percentile (Age <18 years) End of Period 1	73 BMI percentile Standard Deviation 19	73 BMI percentile Standard Deviation 21
Efficacy: BMI Percentile for Participants Age <18 Years Body Mass Index Percentile (Age <18 years) End of Period 2	71 BMI percentile Standard Deviation 22	74 BMI percentile Standard Deviation 21

SECONDARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Glucose levels based on sensor glucose data

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were <54 mg/dL and <70 mg/dL (3.0 and 3.9 mmol/L, Respectively Percentage of Time <54 mg/dL	.50 percentage of time Standard Deviation .35	.46 percentage of time Standard Deviation .33
Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were <54 mg/dL and <70 mg/dL (3.0 and 3.9 mmol/L, Respectively Percentage of Time <70 mg/dL	2.1 percentage of time Standard Deviation 1.4	2.1 percentage of time Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

DKA as defined by the Diabetes Control and Complications Trial (DCCT) and described below:

• Symptoms such as polyuria, polydipsia, nausea, or vomiting;
• Serum ketones >1.5 mmol/L or large/moderate urine ketones;
• Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and
• Treatment provided in a health care facility

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Key Safety Outcome 2) Number of DKA Events	0 Events	0 Events

SECONDARY outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Severe hypoglycemia event as defined by the Diabetes Control and Complications Trial (DCCT) and described below:

The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or loss of consciousness.

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Key Safety Outcome 3) Number of Severe Hypoglycemia Events	0 Events	1 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks for each arm of the crossover

Population: All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Based on sensor glucose data

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Amount of Total Insulin at Daytime, Nighttime and Post-meal Post-Meal Total Insulin Delivery	29 insulin units Standard Deviation 12	29 insulin units Standard Deviation 12
Amount of Total Insulin at Daytime, Nighttime and Post-meal Daytime Total Insulin Delivery	42 insulin units Standard Deviation 18	47 insulin units Standard Deviation 18
Amount of Total Insulin at Daytime, Nighttime and Post-meal Nighttime Total Insulin Delivery	8 insulin units Standard Deviation 4	10 insulin units Standard Deviation 4

OTHER_PRE_SPECIFIED outcome

Timeframe: Time Frame: Screening visit, at initiation (Day 0); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)

Population: One participant in the PID Algorithm group and two participants in the PID + Fuzzy Logic Algorithm group did not complete the questionnaires. Questionnaire scores were calculated based on the ends of crossover periods 1 and 2.

Surveys completed by participants. The Glucose Monitoring Satisfaction Survey is 15 items on a 1-5 scale; Total score calculated as mean of all item scores; higher scores indicate greater satisfaction. The Diabetes Distress Scale is 17 items on a 1-6 scale; Total score calculated as mean of all item scores; higher score denotes more distress. The Hypoglycemia Confidence Survey is 8 items on a 1-4 scale; Total score calculated as mean of all item scores; higher score denotes more confidence. The Diabetes Technology Attitudes Survey is 5 items on a 0-4 scale; Total score calculated as sum of all item scores; higher score denotes more satisfaction with diabetes technology. The Adult INSPIRE Survey is 22 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID. The Adolescent INSPIRE Survey is 17 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID.

Outcome measures

Measure	PID Algorithm n=112 Participants Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=111 Participants Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Glucose Monitoring Satisfaction Survey Mean Score - End of Period 1	2.63 score on a scale Standard Deviation 0.58	2.89 score on a scale Standard Deviation 0.54
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Glucose Monitoring Satisfaction Survey Mean Score - End of Period 2	2.67 score on a scale Standard Deviation 0.69	2.70 score on a scale Standard Deviation 0.54
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Diabetes Distress Scale Total Score - End of Period 1	1.62 score on a scale Standard Deviation 0.71	1.65 score on a scale Standard Deviation 0.68
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Diabetes Distress Scale Total Score - End of Period 2	1.55 score on a scale Standard Deviation 0.56	1.63 score on a scale Standard Deviation 0.82
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Hypoglycemia Confidence Survey Mean Score - End of Period 1	3.52 score on a scale Standard Deviation 0.56	3.51 score on a scale Standard Deviation 0.39
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Hypoglycemia Confidence Survey Mean Score - End of Period 2	3.53 score on a scale Standard Deviation 0.39	3.57 score on a scale Standard Deviation 0.45
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Diabetes Technology Attitudes Survey - End of Period 1	22.33 score on a scale Standard Deviation 3.00	22.40 score on a scale Standard Deviation 3.10
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires Diabetes Technology Attitudes Survey - End of Period 2	22.11 score on a scale Standard Deviation 3.68	22.71 score on a scale Standard Deviation 2.77
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires INSPIRE Survey Adult Version Total Score - End of Period 1	3.81 score on a scale Standard Deviation 1.19	3.79 score on a scale Standard Deviation 1.21
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires INSPIRE Survey Adult Version Total Score - End of Period 2	3.79 score on a scale Standard Deviation 1.29	3.98 score on a scale Standard Deviation 1.27
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires INSPIRE Survey Adolescent Version Total Score - End of Period 1	4.03 score on a scale Standard Deviation 0.94	4.38 score on a scale Standard Deviation 0.60
Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires INSPIRE Survey Adolescent Version Total Score - End of Period 2	4.45 score on a scale Standard Deviation 0.55	4.27 score on a scale Standard Deviation 0.60

Adverse Events

PID Algorithm

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

PID + Fuzzy Logic Algorithm

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	PID Algorithm n=112 participants at risk Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 participants at risk Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Metabolism and nutrition disorders Severe Hypoglycemia	0.00% 0/112 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	0.89% 1/112 • Number of events 1 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.
Gastrointestinal disorders Ruptured Appendix	0.89% 1/112 • Number of events 1 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	0.00% 0/112 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.
Psychiatric disorders Suicidal Tendencies	0.89% 1/112 • Number of events 1 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	0.00% 0/112 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Other adverse events

Measure	PID Algorithm n=112 participants at risk Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor. MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).	PID + Fuzzy Logic Algorithm n=112 participants at risk Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor. Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
Metabolism and nutrition disorders Hyperglycemia or Ketosis Related to Insulin Pump Problem (without diabetic ketoacidosis)	2.7% 3/112 • Number of events 3 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	1.8% 2/112 • Number of events 2 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.
Metabolism and nutrition disorders Hyperglycemia or Ketosis Events not Related to Insulin Pump Problem (without diabetic ketoacidosis)	0.89% 1/112 • Number of events 1 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	0.00% 0/112 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.
Skin and subcutaneous tissue disorders Skin reactions	0.89% 1/112 • Number of events 1 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	1.8% 2/112 • Number of events 2 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.
Gastrointestinal disorders Gastroenteritis	0.00% 0/112 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.	0.89% 1/112 • Number of events 1 • Post-randomization through study completion, an average of 26-weeks All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.

Additional Information

Amy Becker LaFrance, Sr. Manager, Research Project Management Office

HealthPartners Institute

Phone: 952.967.5079

Email: Amy.B.LaFrance@healthpartners.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place