Type 1 DiabetesE3NCT02246582

Adult Accuracy Study of the Enlite 3 Glucose Sensor

A study testing Enlite 3, Guardian Mobile App and 640G Insulin Pump in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes. Read more about this study

Who is it for?: Ages 14 to 75 years
Conditions the study is for: Type 1 Diabetes, Type 2 Diabetes
What is being tested?: Enlite 3, Guardian Mobile App and 640G Insulin Pump
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 6 sitesUnited States
Study dates: Sep 2014to Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject is 14-75 years of age at time of screening
A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 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.

Who cannot join

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 the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
Subject is actively participating in 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 the investigator
Subject is female and plans to become pregnant during the course of the study

Show all 14Show fewer

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Barbara Davis Center
Aurora, Colorado, 80045
AMCR Institute
Escondido, California, 92026
Rainier Clinical Research Center
Renton, Washington, 98057
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use

Read the detailed description

This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year.

Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.

Conditions: Type 1 Diabetes, Type 2 Diabetes
Being tested: Enlite 3, Guardian Mobile App, 640G Insulin Pump
Keywords: Type 1 Diabetes, Type 2 Diabetes, Enlite 3
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enlite 3Device
Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen \& arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile AppDevice
640G Insulin PumpDevice

Study groups in NCT02246582
Study group	Role	What they receive
Group A	Other	Subjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR Receives: Device: Enlite 3; Device: Guardian Mobile App; Device: 640G Insulin Pump
Group B	Other	Subjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR Receives: Device: Enlite 3; Device: Guardian Mobile App; Device: 640G Insulin Pump

What is being measured

The primary outcome is the main question the study is designed to answer.

Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Measured: 7 Days

Secondary outcomes (2)

Retrospective Re-Analysis (MARD With 1 Additional Calibration)
Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Measured: 7 Days
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Aug 2015

First posted23 Sep 2014 (estimated)
Study startSep 2014
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02246582
Sponsor's protocol ID: CEP292
Acronym: E3
Status last verified: Oct 2016
First submitted: 11 Sep 2014
Last updated: 2 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther. 2017 Aug;19(8):446-456. doi: 10.1089/dia.2017.0087. Epub 2017 Jul 12.
PubMed 28700272

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use
ClinicalTrials.gov ID: NCT02246582
Acronym / sponsor ID: E3 / CEP292
Conditions: Type 1 Diabetes, Type 2 Diabetes
Keywords: Type 1 Diabetes, Type 2 Diabetes, Enlite 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 23 Sep 2014 (estimated)
Results: Posted 2 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Other	Device: Enlite 3, Device: Guardian Mobile App, Device: 640G Insulin PumpSubjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group B	Other	Device: Enlite 3, Device: Guardian Mobile App, Device: 640G Insulin PumpSubjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR

Who may qualify

Ages: 14 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Subject is 14-75 years of age at time of screening
A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 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.

Key exclusion criteria (14 listed)

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 the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
Subject is actively participating in 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 the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enlite 3Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen \& arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.	Device	Group A, Group B
Guardian Mobile App	Device	Group A, Group B
640G Insulin Pump	Device	Group A, Group B

Primary outcome

Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
Time frame: 7 Days
Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.

2 secondary outcomes

Retrospective Re-Analysis (MARD With 1 Additional Calibration)
Time frame: 7 Days
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
Time frame: 7 Days

Results and safety

Results posted to the registry on 2 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (FST 30 Mins After Sensor Insertion)	44	41
Group B (FST 14 Hrs After Sensor Insertion)	45	41

Primary outcome: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)

Time frame: 7 Days. Mean (Standard Deviation). Unit: percentage

Measure	Group n = 89
640G Pump	10.55 (9.62)
Guardian Mobile	10.35 (10.39)

Population analysed: Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group	0 of 89 (0%)	5 of 89 (5.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28700272Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther. 2017 Aug;19(8):446-456. doi: 10.1089/dia.2017.0087. Epub 2017 Jul 12.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald Brazg, M.D principal investigator

Rainier Clinical Research Center

Mark Christiansen, M.D principal investigator

Diablo Clinical Research

Timothy Bailey, M.D principal investigator

AMCR Institute

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enlite 3, Guardian Mobile App and 640G Insulin Pump in people with Type 1 Diabetes and Type 2 Diabetes, run by Medtronic MiniMed, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) (time frame: 7 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02246582, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.