NonDiabetesNCT00467675
Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data
An observational study of NonDiabetes and Glucose Variability, run by HealthPartners Institute at 1 site in United States.
Trial summary
In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NonDiabetes, 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2007
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Within normal range for two hour OGTT glucose level (<140 mg/dl)
- Within normal range for fasting glucose level (<100 mg/dl)
- Within normal range for total insulin level as measured by radioimmunoassay
- BMI <30kg/m2
- Age 21-75 years of age, inclusive (15 subjects in the 21-49 years of age group, 15 subjects in the 50-75 years of age group)
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- Willing to give informed consent
- 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 or over 75 years of age
- Abnormal OGTT
- Previous history of diabetes
- Outside of normal insulin range
- BMI > 30kg/m2
- Unable to follow protocol
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- Unable to read and write in English
- Skin abnormalities at insertion sites
- Allergy to adhesives
- Any concomitant medical condition that would likely affect the evaluation of device performance
- Taken prednisone or cortisone medications in the previous 30 days
- Blood transfusion within the past 90 days
- Blood donation within the past 30 days
- Metabolic syndrome (NCEP ATP III guidelines)
- Any medical condition that would affect glucose (per investigator decision)
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 CGM System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making: Phase 2-Establishing Ambulatory Glucose Profiles for Individuals Without Diabetes
In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people without diabetes and to compare these data to the 30 people with diabetes from a previous study. Through this approach it may be possible to develop a means of establishing a model of normal glucose patterns and a basis of comparison with glucose patterns in people with diabetes.
- Conditions
- NonDiabetes, Glucose Variability, CGM
- Being tested
- CGM System for Type 1 and Type 2 Diabetes Mellitus
- Keywords
- NonDiabetes, CGM
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 posted1 May 2007 (estimated)
- Study startApr 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NonDiabetesStudies 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
- 35 participants (actual)
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 InstituteJohnson L. Mary, RN BS CDE, Principal investigator, International Diabetes Center - Park Nicollet InstituteMargaret A. Powers, PhD RD CDE, Principal investigator, International Diabetes Center - Park Nicollet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467675
- Sponsor's protocol ID
- 03403-06-C
- Status last verified
- Sep 2007
- First submitted
- 30 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 CGM System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making: Phase 2-Establishing Ambulatory Glucose Profiles for Individuals Without Diabetes
- ClinicalTrials.gov ID
- NCT00467675
- Acronym / sponsor ID
- 03403-06-C
- Conditions
- NonDiabetes, Glucose Variability, CGM
- Keywords
- NonDiabetes, CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- Apr 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 1 May 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.
In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people without diabetes and to compare these data to the 30 people with diabetes from a previous study. Through this approach it may be possible to develop a means of establishing a model of normal glucose patterns and a basis of comparison with glucose patterns in people with diabetes.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- Within normal range for two hour OGTT glucose level (<140 mg/dl)
- Within normal range for fasting glucose level (<100 mg/dl)
- Within normal range for total insulin level as measured by radioimmunoassay
- BMI <30kg/m2
Key exclusion criteria (15 listed)
- Under 21 years of age or over 75 years of age
- Abnormal OGTT
- Previous history of diabetes
- Outside of normal insulin range
- BMI > 30kg/m2
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.
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 NonDiabetes 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 10 inclusion and 15 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.