In Clinic Evaluation of the PLGM Feature

In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02130284

Acronym

PLGM

Enrollment

Registered

2014-05-05

Start date

2014-10-31

Completion date

2015-09-30

Last updated

2017-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.

Detailed description

A total of up to 95 subjects with type 1 diabetes (age 14-75 years old) will be enrolled at up to 8 investigational centers in order to reach a minimum of 60 subjects who will complete the study (N=minimum 40 adult subjects, 22-75 years old) and N=minimum 15 pediatric subjects (14-21 years old). Subjects will be evaluated in an in-clinic setting with induction of hypoglycemia by increasing their basal rate using a standardized titration tool referred to in protocol as rate of change basal increase algorithm (Buckingham, Diabetes Care 5, 2010). Total duration of frequent sample testing (FST) using Yellow Springs Instrument (YSI) may be up to 19 hours. Subjects will undergo in-clinic testing on Sensor Day 1. 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. The In-Clinic part of the study consists of hypoglycemic induction and an observation period. Hypoglycemic induction ends when one of the following 3 criteria is met, whichever comes first: 1. PLGM is activated 2. YSI glucose is less than or equal to 65 mg/dL, followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples). 3. Neither condition for #1 or #2 has been met in 12 hours Observation with YSI ends when: 1. If PLGM is activated, observation with YSI frequent sample testing will include the Suspend period (30 minutes minimum to 2 hours maximum) and insulin resumption period (approximately 4 hours from the time insulin delivery resumes). This may include insulin re-suspension during this period. Maximum observation with YSI frequent sample testing should be no longer than 19 hours. 2. YSI glucose less than or equal to 65 mg/dL is followed by the next YSI sample less than or equal to 65 mg/dL (2 contiguous YSI samples). The subject will be rescued and YSI observation will end 3. Twelve hours have passed since the start of hypoglycemic induction without PLGM activation 4. See In-Clinic Stopping rules Enrollment for this study will proceed in phases. Phase 1 only allows enrollment of adult subjects (22-75 years). Subjects will wear pump system, as shown below: * One Study Pump * One GST-3C Transmitter * One Enlite 3 Sensor Progression to Phase 2 may occur after 10 adult subjects have completed Phase 1 and a Data Safety Monitoring Board (DSMB) has approved that it is safe to continue on to Phase 2. Phase 2 enrollment involves a minimum of 15 pediatric subjects (14-21). Subjects will wear the same pump system as shown for Phase 1. A total of up to 95 subjects will be enrolled at up to 10 investigational centers in order to reach a minimum of 60 subjects (N=minimum 40 adult subjects and N=minimum 15 pediatric subjects) who will complete the study. Considering around 15% screen failure rate and approximately 15% drop-out rate, a total of up to 95 subjects will be enrolled in order to have 60 subjects complete the study. 1. The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American 2. Subjects will be grouped into cohorts by Age The study is anticipated to last no longer than 12 months from investigational center initiation to completion of all data entry and monitoring procedures including final report. Subjects can expect to participate for approximately 2-3 weeks.

Interventions

DEVICEPredictive 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Subject is 14-75 years of age at time of screening 2. Subject has a clinical diagnosis of type 1 diabetes, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Inclusion Criteria that are Based on Demands of In-Clinic Study Procedures 3. On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio 4. Adequate venous access as assessed by investigator or appropriate staff

Design outcomes

Primary

Measure	Time frame	Description
Rescue Events During In-clinic Procedues	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	—
Unanticipated Device Effect (UADE)	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
Severe Hypoglycemia	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
Diabetic Ketoacidosis	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
Serious Adverse Events (SAE)	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

Other

Measure	Time frame	Description
Sensor Performance: Accuracy	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	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).
Device Metric/Performance - All Device Deficiencies	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	—
PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.	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	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	80
Total	80

Arm

Count

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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Screen Failure	1
Overall Study	Subject's sensor failed at Visit 2, Day	1
Overall Study	Subject was screened as backup for study	3
Overall Study	Subject Withdrew Consent	1
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Predictive Low Glucose Management (PLGM)
Age, Categorical <=18 years	14 Participants
Age, Categorical >=65 years	3 Participants
Age, Categorical Between 18 and 65 years	63 Participants
Age, Continuous	35.0 years STANDARD_DEVIATION 16.9
Region of Enrollment United States	80 participants
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	35 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	5 / 80
serious Total, serious adverse events	0 / 80