DiabetesNCT00707434

Continuous Glucose Monitoring in Critically Ill

A study testing Guardian® blood-sugar monitoring device in people with Diabetes, run by M.D. Anderson Cancer Center at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
What is being tested?: Guardian® blood-sugar monitoring device
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 6 sitesUnited States
Study dates: Jun 2008to Sep 2016
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

Patients in any of our University of Texas collaborative intensive care units.
Critically ill patients on an insulin infusion protocol

Who cannot join

Patients or their legal representatives who do not consent
Patients with large areas of skin affected so as not to allow implantation of device.
Patients < 18 years of age

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708

Other trials in United States

About this study

Official title: Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU

The goal of this clinical research study is to learn if The Guardian® blood-sugar monitoring device can be used reliably in patients with high blood sugar who are receiving care in the ICU. Researchers will compare blood-sugar measurements from the study device with blood-sugar measurements from the standard "fingerstick" method of blood-sugar testing. This is being done to see if the new device can accurately measure blood sugar.

Read the detailed description

The Study Device:

The Guardian® blood-sugar monitoring device is designed to automatically record blood sugar levels many times per hour, without requiring multiple fingersticks. It uses a blood sugar "sensor" (an electronic measuring device) that is about the size of a beeper. The sensor is attached to a small catheter that has a small needle in it. Once the catheter is inserted in the skin, the needle is removed right away.

Use of Study Device:

If you agree to take part in this study, while you are in the ICU, the catheter and needle part of the study device will be inserted under the skin of your abdomen or thigh. The device will automatically measure your blood sugar every 10 seconds so the data can be reviewed by the research staff. The needle will be removed right away. The catheter must be changed every 3 days (+/- 3 days) by the research staff. You will have the study device in place for 15 days (or until you leave the ICU, whichever comes first).

Standard Monitoring of Blood Sugar Levels:

While you are on study, your blood sugar will also be monitored according to the standard of care. This will be in the form of having your blood sugar checked by using a small needle to prick the tip of your finger every hour or more, as necessary.

The blood sugar measurements from the study device will not be used in any way to affect any decisions about your blood sugar monitoring or care.

Length of Study Participation:

After the study device is removed from your body for the last time (after 15 days or when you leave the ICU), you will be considered off study. If intolerable side effects occur, or an infection occurs that seems to have been caused by the study device, you will be taken off study early.

This is an investigational study. The study device is commercially available and FDA approved for monitoring blood sugar levels for outpatient (outside of the hospital) use. Using the device in patients who are in the hospital is considered experimental. At this time, it is only being used in this way in research.

Up to 60 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.

Conditions: Diabetes
Being tested: Guardian® blood-sugar monitoring device
Keywords: Continuous Glucose Monitor, Medtronic Guardian, Guardian® blood-sugar monitoring device, Glucose Monitoring, Critically Ill, ICU, Intensive Care Unit, Glycemic Excursions, Glucose Control, Glucose Testing, Hyperglycemia, Hypoglycemia, Insulin Infusion
Medical subject headings: Diabetes Mellitus, Critical Illness, Hyperglycemia, Hypoglycemia

What participants receive

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

Guardian® blood-sugar monitoring deviceDevice
Also called Continuous Glucose Monitor, Medtronic Guardian
The device has a small catheter that will be inserted subcutaneous tissue of the subject's abdomen or thigh set to continuously monitor glucose throughout the ICU stay for up to 15 days.

Study groups in NCT00707434
Study group	Role	What they receive
Glucose Monitoring Device	Experimental	Continuous glucose monitoring in critically ill patients. Receives: Device: Guardian® blood-sugar monitoring device

What is being measured

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

Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing
Mean relative difference will be calculated on a patient level assuming that at least 6 paired measurements will be collected from each patient.
Outcome represents reliability of CGM device as compared with POC glucose testing where glucose values measured by POC will only be compared with the values read by the continuous glucose monitor sensor at the corresponding time points. The primary outcome for each patient is the mean relative difference defined as average of relative difference at each time point, where relative difference at each time point is calculated by taking difference in glucose values between CGM and POC and then divided by POC glucose value.
Measured: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.

Timeline

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

Jun 2008Sep 2016

First posted30 Jun 2008 (estimated)
Study startJun 2008
Primary completionSep 2016
Study completionSep 2016

Why it stopped: Research administration changes.

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 DiabetesStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00707434
Sponsor's protocol ID: 2007-0616
Other IDs: NCI-2011-01085
Status last verified: Mar 2020
First submitted: 26 Jun 2008
Last updated: 23 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU
ClinicalTrials.gov ID: NCT00707434
Acronym / sponsor ID: 2007-0616
Conditions: Diabetes
Keywords: Continuous Glucose Monitor, Medtronic Guardian, Guardian® blood-sugar monitoring device, Glucose Monitoring, Critically Ill, ICU, Intensive Care Unit, Glycemic Excursions
Study type: Interventional
Recruitment status: TerminatedReason stopped: Research administration changes.
Enrolment: 6 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: Medtronic
Study start: Jun 2008
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 30 Jun 2008 (estimated)
Results: Posted 23 Mar 2020

Clinical summary

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

Detailed description

The Study Device:

Use of Study Device:

Standard Monitoring of Blood Sugar Levels:

The blood sugar measurements from the study device will not be used in any way to affect any decisions about your blood sugar monitoring or care.

Length of Study Participation:

Up to 60 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.

Study design

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

Arm	Type	Receives
Glucose Monitoring Device	Experimental	Device: Guardian® blood-sugar monitoring deviceContinuous glucose monitoring in critically ill patients.

Who may qualify

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

Key inclusion criteria (2 listed)

Patients in any of our University of Texas collaborative intensive care units.
Critically ill patients on an insulin infusion protocol

Key exclusion criteria (3 listed)

Patients or their legal representatives who do not consent
Patients with large areas of skin affected so as not to allow implantation of device.
Patients < 18 years of age

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
Guardian® blood-sugar monitoring deviceAlso: Continuous Glucose Monitor, Medtronic GuardianThe device has a small catheter that will be inserted subcutaneous tissue of the subject's abdomen or thigh set to continuously monitor glucose throughout the ICU stay for up to 15 days.	Device	Glucose Monitoring Device

Primary outcome

Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing
Time frame: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.
Mean relative difference will be calculated on a patient level assuming that at least 6 paired measurements will be collected from each patient. Outcome represents reliability of CGM device as compared with POC glucose testing where glucose values measured by POC will only be compared with the values read by the continuous glucose monitor sensor at the corresponding time points. The primary outcome for each patient is the mean relative difference defined as average of relative difference at each time point, where relative difference at each time point is calculated by taking difference in glucose values between CGM and POC and then divided by POC glucose value.

Results and safety

Results posted to the registry on 23 Mar 2020, 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 Device in ICU	6	5

Primary outcome: Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing

Time frame: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.

Population analysed: Study was terminated due to insufficient funding and data were not collected.

Adverse events

Time frame: Participants monitored for up to 15 days or until leaving the ICU, whichever came first.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Glucose Monitoring in ICU	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Limitations and caveats (from the sponsor): Early termination led to small numbers of subjects analyzable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Recruiting
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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.

Naifa L. Busaidy, MD principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A study testing Guardian® blood-sugar monitoring device in people with Diabetes, run by M.D. Anderson Cancer Center 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Mar 2020. 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 23 Mar 2020). 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?

Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing (time frame: Continuously monitor patient's glucose throughout their ICU stay for up to 15 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 NCT00707434.

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 23 Mar 2020.