Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System

A study testing DexCom™ G4 Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by DexCom, Inc..

Completed

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

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: DexCom™ G4 Continuous Glucose Monitoring System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: Feb 2010to Apr 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older;
Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
Willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration;
Willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes);

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Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
Able to speak, read, and write English.

Who cannot join

Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
Subjects who have a known allergy to medical-grade adhesives;
Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
Have a hematocrit that is less than 30%, or greater than 55%;
Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).

About this study

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin.

Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study (PTL-900360) meeting the above criteria will be compared to the proportion of such points observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL 300012).

Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.

Read the detailed description

This will be a non-randomized, single-armed study conducted in the United States. Following screening, a minimum of 60 to a maximum of 80 subjects at up to 4 clinical sites will be enrolled. All participants will wear the G4 Sensor for one 7-day wear period (~168 hours). A subset of 20-30 subjects will wear two G4 Systems (one of which will be blinded) during the 7-day wear period for the purposes of assessing precision. During home use, subjects will be asked to use the meter provided to them to take fingersticks for calibration and diabetes management. Subjects will also be asked to confirm high and low G4 System glucose alerts/alarms by taking a comparative fingerstick immediately after receiving an alert/alarm.

All subjects will participate in one, 8-hour in-clinic session on Day 1, 4, or 7 of the study to collect accuracy information against a laboratory standard (YSI) and against SMBG. During the in-clinic session, subjects will have venous blood draws for evaluation of the YSI blood glucose measurements. Carbohydrate consumption and insulin dosing may be manipulated during the in-clinic session to ensure a wide range of glucose values. For the duration of this study, subjects will be instructed to use G4 System information as an adjunct to (and not as a replacement for) standard SMBG guidance of diabetes self-management.

Subjects will perform G4 Sensor insertions at the clinic under supervision of study staff. Sensor insertion sites will be examined after removal of the Sensor(s). Study staff will document any irritation and/or Adverse Device Effects.

Conditions: Diabetes Mellitus
Being tested: DexCom™ G4 Continuous Glucose Monitoring System
Keywords: diabetes mellitus requiring insulin
Medical subject headings: Diabetes Mellitus

What participants receive

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

DexCom™ G4 Continuous Glucose Monitoring SystemDevice
Also called Continuous Glucose Monitoring System
Continuous Glucose Monitoring System

Study groups in NCT01111370
Study group	Role	What they receive
CGM	Experimental	continuous glucose monitoring system Receives: Device: DexCom™ G4 Continuous Glucose Monitoring System

What is being measured

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

the Proportion of G4 CGM System in Agreement With the Reference Standard
The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels >80 mg/dL and (±) 20 mg/dL at YSI glucose levels <80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.
Measured: Assessment done on either Day 1, 4 or 7 of the sensor wear period

Timeline

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

Feb 2010Apr 2010

First posted27 Apr 2010 (estimated)
Study startFeb 2010
Primary completionApr 2010
Study completionApr 2010

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.
Other trials for Diabetes MellitusStudies 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
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01111370
Sponsor's protocol ID: PTL900360
Status last verified: Aug 2015
First submitted: 22 Apr 2010
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

Official record

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Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
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Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
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Pentoxifylline in Diabetic Kidney Disease
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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System
ClinicalTrials.gov ID: NCT01111370
Acronym / sponsor ID: PTL900360
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus requiring insulin
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: DexCom, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 27 Apr 2010 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

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

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CGM	Experimental	Device: DexCom™ G4 Continuous Glucose Monitoring Systemcontinuous glucose monitoring system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age 18 years or older;
Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
Willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration;

Key exclusion criteria (6 listed)

Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
Subjects who have a known allergy to medical-grade adhesives;
Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
Have a hematocrit that is less than 30%, or greater than 55%;
Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);

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
DexCom™ G4 Continuous Glucose Monitoring SystemAlso: Continuous Glucose Monitoring SystemContinuous Glucose Monitoring System	Device	CGM

Primary outcome

the Proportion of G4 CGM System in Agreement With the Reference Standard
Time frame: Assessment done on either Day 1, 4 or 7 of the sensor wear period
The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels >80 mg/dL and (±) 20 mg/dL at YSI glucose levels <80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Glucose Monitoring System	60	58

Primary outcome: the Proportion of G4 CGM System in Agreement With the Reference Standard

Time frame: Assessment done on either Day 1, 4 or 7 of the sensor wear period. Mean (95% Confidence Interval). Unit: %20/20

Measure	CGM Device n = 60
Value	80 (78 to 82)

Population analysed: Randomly enrolled

Adverse events

Time frame: 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Real Time Continuous Glucose Monitoring System	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
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Continuous Glucose Monitoring, Type 1 Diabetes

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.

Andrew Balo study chair

DexCom, Inc.

Questions about this trial

What is this clinical trial studying?

A study testing DexCom™ G4 Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by DexCom, Inc..

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 9 inclusion and 6 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

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 27 Mar 2017). 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?

the Proportion of G4 CGM System in Agreement With the Reference Standard (time frame: Assessment done on either Day 1, 4 or 7 of the sensor wear period). 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 NCT01111370.

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 27 Mar 2017.