Diabetes MellitusNCT01364766
Continuous Glucose Monitor Use in School
An observational study of Diabetes Mellitus, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Anyone with diabetes mellitus who is wearing a continous glucose sensor and is in school.
Who may be able to join
- Diabetes use continuous glucose monitor in school
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Impact of Continuous Glucose Monitor Use in the Classroom/School Environment
The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes.
Read the detailed description
The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. Recent technological advancements in diabetes management have resulted in increased use of devices during class/school. Although many studies have examined the quality of life and the impact on the family and subject of these devices, to our knowledge this is the first study that will examine the impact of the continuous glucose monitor during class/school. To our knowledge, this is first study to involve the teachers. The results of this study is particularly important since the future of diabetes therapy will be to use continuous glucose monitors and insulin pumps to develop a closed loop system of insulin therapy or "artificial pancreas."
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM usefulness score
Measured: 1 yr
Secondary outcomes (1)
Diabetes Comfort score
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tandy Aye, Stanford University
- Investigators
- Tandy Aye MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364766
- Sponsor's protocol ID
- SU-08122010-6709
- Status last verified
- Apr 2016
- First submitted
- 31 May 2011
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Benassi K, Drobny J, Aye T. Real-time continuous glucose monitoring systems in the classroom/school environment. Diabetes Technol Ther. 2013 May;15(5):409-12. doi: 10.1089/dia.2012.0314. Epub 2013 Mar 26.
PubMed 23530577
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continuous Glucose Monitor Use in the Classroom/School Environment
- ClinicalTrials.gov ID
- NCT01364766
- Acronym / sponsor ID
- SU-08122010-6709
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Jun 2011 (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 find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes.
Detailed description
The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. Recent technological advancements in diabetes management have resulted in increased use of devices during class/school. Although many studies have examined the quality of life and the impact on the family and subject of these devices, to our knowledge this is the first study that will examine the impact of the continuous glucose monitor during class/school. To our knowledge, this is first study to involve the teachers. The results of this study is particularly important since the future of diabetes therapy will be to use continuous glucose monitors and insulin pumps to develop a closed loop system of insulin therapy or "artificial pancreas."
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Anyone with diabetes mellitus who is wearing a continous glucose sensor and is in school.
Key inclusion criteria (1 listed)
- Diabetes use continuous glucose monitor in school
Key exclusion criteria (0 listed)
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
CGM usefulness score
Time frame: 1 yr
1 secondary outcome
Diabetes Comfort score
Time frame: 1 yr
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 14 Apr 2016.
- Derived from this study: PubMed 23530577Benassi K, Drobny J, Aye T. Real-time continuous glucose monitoring systems in the classroom/school environment. Diabetes Technol Ther. 2013 May;15(5):409-12. doi: 10.1089/dia.2012.0314. Epub 2013 Mar 26.
- Individual participant dataSharing planned: Undecided
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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.
Tandy Aye MD principal investigator
Stanford University
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 Stanford University 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 1 inclusion and 0 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 14 Apr 2016. 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?
CGM usefulness score (time frame: 1 yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364766, which also lists 1 linked publication.
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 14 Apr 2016.