Diabetes Mellitus, Type 1NCT00722241
Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by DexCom, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the next-generation DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Type of treatment
- Injection or infusion
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Jul 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ambulatory (non-hospitalized) individuals with type 1 diabetes or insulin-treated type 2 diabetes selected from endocrinology clinics within the United States
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(s) 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Advanced Metabolic Care + Research
Escondido, California, 92026
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
The purpose of this study is to evaluate the safety and effectiveness of the next-generation DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin therapy.
- Keywords
- Continuous Glucose Monitoring, Interstitial Fluid, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, 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 |
|---|---|---|
| A | Adult subjects (at least 18 years of age) with a diagnosis of type 1 diabetes (~80%) or insulin-treated type 2 diabetes (~20%); method of insulin delivery may be multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements
Measured: Days 1, 4, and 7 of Sensor wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew K Balo, BS, Study chair, DexCom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722241
- Sponsor's protocol ID
- PTL-300012, Rev01
- Status last verified
- Jul 2008
- First submitted
- 23 Jul 2008
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT00722241
- Acronym / sponsor ID
- PTL-300012, Rev01
- Keywords
- Continuous Glucose Monitoring, Interstitial Fluid, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Jul 2008 (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 next-generation DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Adult subjects (at least 18 years of age) with a diagnosis of type 1 diabetes (~80%) or insulin-treated type 2 diabetes (~20%); method of insulin delivery may be multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory (non-hospitalized) individuals with type 1 diabetes or insulin-treated type 2 diabetes selected from endocrinology clinics within the United States
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(s) 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.
Primary outcome
SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements
Time frame: Days 1, 4, and 7 of Sensor wear
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 25 Jul 2008.
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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.
Andrew K Balo, BS study chair
DexCom, Inc.
3 sites 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, Type 1 and Diabetes Mellitus, Type 2, run by DexCom, Inc. at 3 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 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 25 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements (time frame: Days 1, 4, and 7 of Sensor wear). 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 25 Jul 2008; AzTrials last refreshed its copy on 6 Nov 2026.