Diabetes MellitusNCT01185496
Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus
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 safety and effectiveness of the G4 System when worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Nov 2010
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This clinical study population will consist of a minimum of 64 and up to 80 subjects with a previous diagnosis of type 1 diabetes mellitus. It is desirable to achieve an equal number of subjects enrolled into each of the following four subgroups as defined in the FDA guideline for Age Ranges of Pediatric Subgroups: * Female children* 6-12 years-old * Female adolescents** 13-17 years-old * Male children 6-12 years-old * Males adolescents 13-17 years-old
Who may be able to join
- 1. Age 6 to <18 years-old;
- 2. Have been diagnosed with type 1 diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
- 3. Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
- 4. Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear, and willing to adhere to the protocol-specified fingerstick schedule during home use;
- 5. Willing to participate in three consecutive 7-day Sensor wear periods;
- 6. Willing to take a minimum of 7 fingersticks per day during home use (2 for calibration purposes, 5 for comparative purposes);
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- 7. Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
- 8. Willing not to schedule an magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
- 9. Both subject and guardian are able to speak, read, and write English.
Who cannot join
- 1. 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; 2. Subjects who have a known allergy to medical-grade adhesives; 3. For participants of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion (sexually active participants of childbearing potential must use birth control during this study); 4. Have a hematocrit that is less than 30%, or greater than 55%; 5. 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); 6. 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 (e.g., known history of hepatitis B or C).
Trial locations and contacts
1 site in 1 country.
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 children and adolescent subjects (6 to <18 years-old) with type 1 diabetes mellitus.
Read the detailed description
Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of the study meter reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. This proportion will be compared to the proportion of such points observed in the DexCom clinical study that will be used to apply for FDA approval of the G4 System (PTL 900360) for adults.
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.
- Conditions
- Diabetes Mellitus
- Keywords
- 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 |
|---|---|---|
| CGM | Blinded/Unblinded CGM wear in adjunct with SMBG meter diabetes management |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185496
- Sponsor's protocol ID
- PTL-900220
- Status last verified
- Jun 2011
- First submitted
- 18 Aug 2010
- Last updated
- 13 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. 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 in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01185496
- Acronym / sponsor ID
- PTL-900220
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Aug 2010 (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 purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by children and adolescent subjects (6 to <18 years-old) with type 1 diabetes mellitus.
Detailed description
Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of the study meter reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. This proportion will be compared to the proportion of such points observed in the DexCom clinical study that will be used to apply for FDA approval of the G4 System (PTL 900360) for adults.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM | – | –Blinded/Unblinded CGM wear in adjunct with SMBG meter diabetes management |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This clinical study population will consist of a minimum of 64 and up to 80 subjects with a previous diagnosis of type 1 diabetes mellitus. It is desirable to achieve an equal number of subjects enrolled into each of the following four subgroups as defined in the FDA guideline for Age Ranges of Pediatric Subgroups: * Female children* 6-12 years-old * Female adolescents** 13-17 years-old * Male children 6-12 years-old * Males adolescents 13-17 years-old
Key inclusion criteria (9 listed)
- 1. Age 6 to <18 years-old;
- 2. Have been diagnosed with type 1 diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
- 3. Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
- 4. Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear, and willing to adhere to the protocol-specified fingerstick schedule during home use;
- 5. Willing to participate in three consecutive 7-day Sensor wear periods;
Key exclusion criteria (1 listed)
- 1. 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; 2. Subjects who have a known allergy to medical-grade adhesives; 3. For participants of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion (sexually active participants of childbearing potential must use birth control during this study); 4. Have a hematocrit that is less than 30%, or greater than 55%; 5. 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); 6. 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 (e.g., known history of hepatitis B or C).
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
Not reported in the source record.
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 13 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 9 inclusion and 1 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 13 Jun 2011. 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?
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.
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 13 Jun 2011.