Pediatric Subjects With Diabetes MellitusNCT01667185
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
An observational study of Pediatric Subjects With Diabetes Mellitus, run by DexCom, Inc. at 6 sites in United States.
Trial summary
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Pediatric Subjects With Diabetes Mellitus
- How many people
- 176 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Pediatric subjects with diabetes mellitus
Who may be able to join
- Ages 2 to 17 years ;
- Diagnosis of diabetes mellitus;
- Willing to participate in one 7-day Sensor wear period;
- Willing to wear 2 systems simultaneously;
- Willing to take a minimum of 7 fingersticks per day during home use with a blood glucose meter provided;
- Willing to attend one in-clinic session of up to 6 hours duration. Clinic procedures where blood sampling via SMBG and/or venous YSI method, depending on age;
- Subject or guardian is able to speak, read, and write English.
Who cannot join
- Extensive skin changes/diseases at sensor wear site 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);
- Known allergy to medical-grade adhesives;
- Require a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, or diathermy during the wear period. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their continuous glucose monitoring (CGM) session, and remove their sensor.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Barbara Davis Center
Aurora, Colorado, 80045
Joslin Diabetes Center
Boston, Massachusetts, 02215
Advanced Metabolic Care and Research
Escondido, California, 92026
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, 83404
CHOC Children's
Orange, California, 92868
Stanford University
Stanford, California, 94305
About this study
Official title: Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as 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 YSI glucose levels <80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly.
Read more
Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants.
Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).
- Keywords
- pediatric, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric subjects with diabetes mellitus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Performance Effectiveness
The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
Measured: 7 days
Secondary outcomes (1)
System Performance at Alternate Wear Site
An additional objective is to evaluate System performance at an alternate wear site. The System performance will be assessed, using the same statistical methodology as the primary wear site.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Subjects With 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667185
- Sponsor's protocol ID
- PTL900803
- Status last verified
- Feb 2013
- First submitted
- 15 Aug 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01667185
- Acronym / sponsor ID
- PTL900803
- Keywords
- pediatric, diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as 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 YSI glucose levels <80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly.
Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants.
Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric subjects with diabetes mellitus | – | – |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric subjects with diabetes mellitus
Key inclusion criteria (7 listed)
- Ages 2 to 17 years ;
- Diagnosis of diabetes mellitus;
- Willing to participate in one 7-day Sensor wear period;
- Willing to wear 2 systems simultaneously;
- Willing to take a minimum of 7 fingersticks per day during home use with a blood glucose meter provided;
Key exclusion criteria (3 listed)
- Extensive skin changes/diseases at sensor wear site 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);
- Known allergy to medical-grade adhesives;
- Require a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, or diathermy during the wear period. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their continuous glucose monitoring (CGM) session, and remove their sensor.
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
System Performance Effectiveness
Time frame: 7 days
The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
1 secondary outcome
System Performance at Alternate Wear Site
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Subjects With Diabetes Mellitus, run by DexCom, 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 7 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: finished, as of the sponsor's last update on 8 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
System Performance Effectiveness (time frame: 7 days). 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 8 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.