Diabetes MellitusNCT02363907
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics
An observational study of Diabetes Mellitus, run by DexCom, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2012
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents with diabetes mellitus (Type 1 or Type 2)
Who may be able to join
- Ages 2 to 17 years;
- Diagnosis of diabetes mellitus;
- Treatment of diabetes with insulin and/or oral diabetes medication Note: Insulin-using subjects only - willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
- Willing to refrain from the use of medications containing acetaminophen during the sensor insertion period and for one day prior to sensor insertion;
- Able to perform up to 7 fingersticks per day during home use (approximately 2 calibration fingersticks or as often as prompted by the device and approximately 5 for diabetes management and/or detection of hyper and hypoglycemia); and
- Subject or guardian is able to speak, read, and write English.
Who cannot join
- Extensive skin changes/diseases that preclude wearing the required number of devices 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;
- Known allergy to medical-grade adhesives;
- For subjects of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours prior to device insertion;
- Hematocrit value outside the range of the blood glucose monitoring system used in the study;
- 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);
- Planned MRI scan, CT scan, or diathermy during the week of the study; or
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C, or HIV).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
About this study
Official title: Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.
Read the detailed description
Performance of the system will be primarily evaluated by comparing the blood glucose measurements from the reference device, a blood glucose meter, to the CGM System values collected during the study. Specifically, performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values <80 mg/dL. These G4-meter matched pairs will be analyzed across the 7 days of wear.
Safety data of the CGM System will also be collected and safety will be characterized by the incidence of anticipated device-related adverse events (ADEs) of subjects who participate in the study.
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, pediatric, continuous glucose monitoring system, CGM
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device
"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL
Measured: Measured during clinic session during 7 day sensor wear period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Liljenquist, M.D., Principal investigator, Rocky Mountain Diabetes and Osteoporosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363907
- Sponsor's protocol ID
- PTL-900982
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4
- ClinicalTrials.gov ID
- NCT02363907
- Acronym / sponsor ID
- PTL-900982
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, pediatric, continuous glucose monitoring system, CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 27 Jul 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 effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.
Detailed description
Performance of the system will be primarily evaluated by comparing the blood glucose measurements from the reference device, a blood glucose meter, to the CGM System values collected during the study. Specifically, performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values <80 mg/dL. These G4-meter matched pairs will be analyzed across the 7 days of wear.
Safety data of the CGM System will also be collected and safety will be characterized by the incidence of anticipated device-related adverse events (ADEs) of subjects who participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents with diabetes mellitus (Type 1 or Type 2)
Key inclusion criteria (6 listed)
- Ages 2 to 17 years;
- Diagnosis of diabetes mellitus;
- Treatment of diabetes with insulin and/or oral diabetes medication Note: Insulin-using subjects only - willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
- Willing to refrain from the use of medications containing acetaminophen during the sensor insertion period and for one day prior to sensor insertion;
- Able to perform up to 7 fingersticks per day during home use (approximately 2 calibration fingersticks or as often as prompted by the device and approximately 5 for diabetes management and/or detection of hyper and hypoglycemia); and
Key exclusion criteria (7 listed)
- Extensive skin changes/diseases that preclude wearing the required number of devices 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;
- Known allergy to medical-grade adhesives;
- For subjects of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours prior to device insertion;
- Hematocrit value outside the range of the blood glucose monitoring system used in the study;
- 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.
Primary outcome
Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device
Time frame: Measured during clinic session during 7 day sensor wear period
"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Liljenquist, M.D. principal investigator
Rocky Mountain Diabetes and Osteoporosis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by DexCom, Inc. at 1 site 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 6 inclusion and 7 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 27 Jul 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?
Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device (time frame: Measured during clinic session during 7 day sensor wear period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2017.