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A Performance Evaluation of the Enlite 3 Sensor

Primary Purpose

Type 1 Diabetes

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enlite 3 Sensor

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Type 2 Diabetes, Enlite 3 Sensor, Continuous Glucose Monitoring

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is 14 - 75 years of age at time of screening.
A clinical diagnosis of type 1 or 2 diabetes for a minimum of 9 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Adequate venous access as assessed by investigator or appropriate staff
Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.

Exclusion Criteria:

Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual.
Subject has any unresolved adverse skin condition in the area of Enlite 3 Sensors 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 is female and has a positive pregnancy screening test
Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator.
Subject is female and plans to become pregnant during the course of the study
Subject has had a hypoglycemic seizure within the past 6 months.
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.
Subject has a hematocrit(Hct) lower than the normal reference range.
Subject has a history of adrenal insufficiency

Sites / Locations

Diablo Clinical Research
Rainier Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

Outcomes

Primary Outcome Measures

Enlite 3 Sensor inserted at Arm accuracy using a real time device: (640G pump) with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated.

Glucose sensor values will be compared to Yellow Spring Instruments (YSI)plasma glucose values during Frequent Sample Testing.

Secondary Outcome Measures

Full Information

NCT ID

NCT02649010

First Posted

January 4, 2016

Last Updated

June 21, 2016

Sponsor

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT02649010

Brief Title

A Performance Evaluation of the Enlite 3 Sensor

Official Title

A Performance Evaluation of the Enlite 3 Sensor

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Business Decision

Study Start Date

January 2016 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor performance in arm in subjects age 14 - 75 years.

Detailed Description

The study is a multi-center, randomized, prospective single-sample correlational design without controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Type 1 Diabetes, Type 2 Diabetes, Enlite 3 Sensor, Continuous Glucose Monitoring

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.

Intervention Type

Device

Intervention Name(s)

Enlite 3 Sensor

Intervention Description

Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the arm and used with the 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 12 months.

Primary Outcome Measure Information:

Title

Enlite 3 Sensor inserted at Arm accuracy using a real time device: (640G pump) with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated.

Description

Glucose sensor values will be compared to Yellow Spring Instruments (YSI)plasma glucose values during Frequent Sample Testing.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is 14 - 75 years of age at time of screening. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 9 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis Adequate venous access as assessed by investigator or appropriate staff Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only. Exclusion Criteria: Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual. Subject has any unresolved adverse skin condition in the area of Enlite 3 Sensors 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 is female and has a positive pregnancy screening test Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator. Subject is female and plans to become pregnant during the course of the study Subject has had a hypoglycemic seizure within the past 6 months. 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. Subject has a hematocrit(Hct) lower than the normal reference range. Subject has a history of adrenal insufficiency

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Lee, MD

Organizational Affiliation

Medtronic Diabetes

Official's Role

Study Director

Facility Information:

Facility Name

Diablo Clinical Research

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Rainier Clinical Research Center

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Performance Evaluation of the Enlite 3 Sensor

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