Diabetes MellitusLUCIDNCT01627184
Long-term Use: CGM System Assessment in Adult Athletes With 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 CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Dexcom G4 CGM System
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2013
- 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: Adult athletes with diabetes mellitus
Who may be able to join
- Age 18 years or older
- Diagnosis of diabetes mellitus
Who cannot join
- Extensive skin changes/diseases
- Known allergy to medical adhesives
- Pregnancy
- Dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Diabetes Association
Atlanta, Georgia, 30309
About this study
The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.
- Conditions
- Diabetes Mellitus
- Being tested
- Dexcom G4 CGM System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G4 CGM SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Athletes with diabetes mellitus | Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time Receives: Device: Dexcom G4 CGM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control during Exercise
The proportion of time spent in euglycemia zone as well as hypoglycemia zone will be determined from the system glucose readings, particularly during subject's high levels of activity. Longitudinal data analysis methods will be used to assess the within-subject and between-subject effects of the glycemic control for the study population.
Measured: multiple months, up to 6
Secondary outcomes (1)
System Utility and Usability
The objectives of the study are to evaluate the Dexcom G4 system utility and usability during high levels of activity and home use. The assessments may be evaluated by, but are not limited to, the following:
- Number and duration of sensors used by subject
- Percentage of CGM system communication during wear
- Percentage of CGM system glucose reading during wear
- Incidence of System prompts and error messages recorded in the receiver
Measured: multiple months, up to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJun 2013
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
- 13 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
- NCT01627184
- Sponsor's protocol ID
- PTL-900905
- Acronym
- LUCID
- Status last verified
- Feb 2015
- First submitted
- 21 Jun 2012
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01627184
- Acronym / sponsor ID
- LUCID / PTL-900905
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Jun 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 purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes with diabetes mellitus | – | Device: Dexcom G4 CGM SystemAthletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult athletes with diabetes mellitus
Key inclusion criteria (2 listed)
- Age 18 years or older
- Diagnosis of diabetes mellitus
Key exclusion criteria (4 listed)
- Extensive skin changes/diseases
- Known allergy to medical adhesives
- Pregnancy
- Dialysis
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 |
|---|---|---|
| Dexcom G4 CGM System | Device | Athletes with diabetes mellitus |
Primary outcome
Glycemic Control during Exercise
Time frame: multiple months, up to 6
The proportion of time spent in euglycemia zone as well as hypoglycemia zone will be determined from the system glucose readings, particularly during subject's high levels of activity. Longitudinal data analysis methods will be used to assess the within-subject and between-subject effects of the glycemic control for the study population.
1 secondary outcome
System Utility and Usability
Time frame: multiple months, up to 6
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 12 Feb 2015.
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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 2 inclusion and 4 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 12 Feb 2015. 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.
What does the primary outcome measure?
Glycemic Control during Exercise (time frame: multiple months, up to 6). 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 12 Feb 2015.