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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic Diabetes
- Enrollment
- 80
- Locations
- 16
- Primary Endpoint
- Unanticipated Device Effect (UADE)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is 14-75 years of age at time of screening
- •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
- •On pump therapy at the time of screening with insulin sensitivity and insulin carbohydrate ratio
- •Adequate venous access as assessed by investigator or appropriate staff
Exclusion Criteria
- •Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures
- •Subject is unable to tolerate tape adhesive in the area of sensor placement
- •Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- •Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
- •Subject has a positive urine or serum pregnancy screening test
- •Subject is female, sexually active without use of contraception and plans to become pregnant during the course of the study
- •Subject has had a hypoglycemic induced seizure within the past 6 months prior to screening visit
- •Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- •Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
- •Subject has a history of a seizure disorder
- •Subject has central nervous system or cardiac disorder resulting in syncope
- •Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- •Subjects with hematocrit (Hct) lower than the normal reference range for age per local lab testing
- •Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
- •Subjects with a history of adrenal insufficiency
- •Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment
Arms & Interventions
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
Intervention: Predictive Low Glucose Management Feature in Insulin pump (Device)
Outcomes
Primary Outcomes
Unanticipated Device Effect (UADE)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Rescue Events During In-clinic Procedues
Time Frame: 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
Serious Adverse Events (SAE)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported