Trial Outcomes & Findings for In Clinic Evaluation of the PLGM Feature (NCT NCT02130284)

NCT ID: NCT02130284

Last Updated: 2017-09-28

Results Overview

Evaluation of incidence of SAE during in-clinic procedures

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures
• Results posted on: 2017-09-28

Participant Flow

Participant milestones

Measure	Predictive Low Glucose Management (PLGM) To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
Overall Study STARTED	80
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Predictive Low Glucose Management (PLGM) To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
Overall Study Withdrawal by Subject	3
Overall Study Subject Withdrew Consent	1
Overall Study Subject's sensor failed at Visit 2, Day	1
Overall Study Subject was screened as backup for study	3
Overall Study Screen Failure	1

Baseline Characteristics

In Clinic Evaluation of the PLGM Feature

Baseline characteristics by cohort

Measure	Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	35.0 years STANDARD_DEVIATION 16.90 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Evaluation of incidence of SAE during in-clinic procedures

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Serious Adverse Events (SAE)

0 Participants

PRIMARY outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Evaluation of incidence of UADE during in-clinic procedures

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Unanticipated Device Effect (UADE)

0 Participants

PRIMARY outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Evaluation of incidence of severe hypoglycemia during in-clinic procedures

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Severe Hypoglycemia

0 Participants

PRIMARY outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Evaluation of DKA during in-clinic procedures

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Diabetic Ketoacidosis

0 Participants

PRIMARY outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Rescue Events During In-clinic Procedues

7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Population: Two subjects were excluded from analysis because the site staff did not set the pump up correctly prior to YSI and the PLGM feature was never set to activate.

Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures.

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=69 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.

39.13 percentage of total subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Population: Total of 71 subjects completed the study. However, two subjects who withdrew also had YSI and Sensor glucose values. Therefore, total of 73 subjects contributed to sensor accuracy analysis

MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=73 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Sensor Performance: Accuracy

12.56 percentage Standard Deviation 10.06

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures

Outcome measures

Measure

Predictive Low Glucose Management (PLGM) n=80 Participants To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

Device Metric/Performance - All Device Deficiencies

13 device performance issues

Adverse Events

Predictive Low Glucose Management (PLGM)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Predictive Low Glucose Management (PLGM) n=80 participants at risk To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
Infections and infestations Upper respiratory infection	1.2% 1/80 • Number of events 1
Injury, poisoning and procedural complications Mild back strain	1.2% 1/80 • Number of events 1
Gastrointestinal disorders emesis	1.2% 1/80 • Number of events 1
Nervous system disorders headache	1.2% 1/80 • Number of events 1
General disorders pain	1.2% 1/80 • Number of events 1

Additional Information

Suiying Huang, Statistician

Medtronic Minimed

Phone: 818-576-3319

Email: suiying.huang@medtronic.com

Results disclosure agreements

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

Restriction type: GT60