DiabetesNCT00465881
Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes
An observational study of Diabetes and Glucose Variability, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Glucose Variability, CGM
- What is being tested?
- CGM System for Type 1 and Type 2 Diabetes Mellitus
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2006
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Diagnosed with type 1 or type 2 diabetes
- Treated with insulin therapy
- Can also be taking other diabetes medication treatment
- Age 21 and older
- Willing to give informed consent
Show all 9Show fewer
- Capable of following the protocol and instructions of study staff
- Available for scheduled visits
- Access to telephone communications
Who cannot join
- Under 21 years of age
- Unable to follow protocol
- Unable to read and write in English
- Skin abnormalities at insertion sites
- Allergy to adhesives
- Any concomitant medication thay would likely affect evaluation of device
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center - Park Nicollet Health Services
Minneapolis, Minnesota, 55416
About this study
Official title: Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making
The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience. The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained.
Read the detailed description
There are two purposes to the study. First, to use an investigational device, the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care) to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG. The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making. Because of the evidence that glucose regulation may be indirectly related to blood pressure levels, a second purpose of the study is to monitor variation in BP control by means of self-monitored BP.
- Conditions
- Diabetes, Glucose Variability, CGM
- Being tested
- CGM System for Type 1 and Type 2 Diabetes Mellitus
- Keywords
- Diabetes, CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM System for Type 1 and Type 2 Diabetes MellitusDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startJan 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Investigators
- Roger S. Mazze, PhD, Principal investigator, International Diabetes Center - Park Nicollet InstituteRichard M. Bergenstal, MD, Principal investigator, International Diabetes Center - Park Nicollet InstituteEllie S. Strock, RN BC-ANP, Principal investigator, International Diabetes Center - Park Nicollet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465881
- Sponsor's protocol ID
- 01929-05-C
- Status last verified
- Sep 2007
- First submitted
- 24 Apr 2007
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making
- ClinicalTrials.gov ID
- NCT00465881
- Acronym / sponsor ID
- 01929-05-C
- Conditions
- Diabetes, Glucose Variability, CGM
- Keywords
- Diabetes, CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- Jan 2006
- Study completion
- Apr 2006 (actual)
- First posted
- 25 Apr 2007 (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 obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience. The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained.
Detailed description
There are two purposes to the study. First, to use an investigational device, the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care) to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG. The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making. Because of the evidence that glucose regulation may be indirectly related to blood pressure levels, a second purpose of the study is to monitor variation in BP control by means of self-monitored BP.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Diagnosed with type 1 or type 2 diabetes
- Treated with insulin therapy
- Can also be taking other diabetes medication treatment
- Age 21 and older
Key exclusion criteria (6 listed)
- Under 21 years of age
- Unable to follow protocol
- Unable to read and write in English
- Skin abnormalities at insertion sites
- Allergy to adhesives
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 |
|---|---|---|
| CGM System for Type 1 and Type 2 Diabetes Mellitus | Device | – |
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 3 Dec 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.
Roger S. Mazze, PhD principal investigator
International Diabetes Center - Park Nicollet Institute
Richard M. Bergenstal, MD principal investigator
International Diabetes Center - Park Nicollet Institute
Ellie S. Strock, RN BC-ANP principal investigator
International Diabetes Center - Park Nicollet Institute
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 and Glucose Variability, run by HealthPartners Institute 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 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 3 Dec 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.
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 3 Dec 2015.