- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253237
Primary Care - Continuous Glucose Monitoring (PC-COSMO)
August 17, 2017 updated by: Valerija Bralic Lang, University of Zagreb
Continuous Glucose Monitoring in Patients With Diabetes Mellitus Type 2 in Primary Care
Introduction and objective: The key to optimal diabetes management is tight glucose control.
Hemoglobin A1c is the gold standard to assess glycemic control but in cases of unrecognized hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a haemoglobin A1c can not detect specific movement of blood glucose.
Continuous glucose monitoring (CGM) provides informations of glucose levels in a real-time format and may be helpful for making the personalized therapy decisions desired in the era of precision medicine.
Our aim is to analyse the benefit of tracking patterns of glucose values by using continuous glucose monitoring (CGM) in patients with T2DM in family medicine office.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
STUDY DESIGN: An observational, multicenter, cross-sectional study.
A total of 20 GPs from four Croatian regions will recruit up to five subjects of both sexes from August 2017 till the end of September 2017, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with no insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycemia na haemoglobin A1c findings.
Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol, high density cholesterol, low density cholesterol, triglyceride and serum creatinine) and habits data will be collected.
SETTING: Totally 100 of patients will be included.
At primary care office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days and return it to the office for download.
Patients do not receive glucose alerts and only see the CGM data after it's been analyzed by the healthcare professional.
A CGM device is to be set and take of by the GP.
Before the study start all GPs will have a short education on CGM device by the diabetologist who use CGM on a daily base.
Study period is seven days and includes screening before study entry and two visits.
On Day 1, after screening and signing the informed consent, the CGM device is applied.
Patient is instructed to keep a 7 day diary with four daily standard home blood glucose monitoring (SHBGM) along with the data on eating, physical exercise, drugs.
Bayer's Contour® glucometer is used for the SHBGM.
On Day 7, CGM device is took of and the data from iPro2 is uploaded to PC.
At the end, each patient fill a short query on satisfaction while wearing CGM.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Valerija Lang, PhD
- Phone Number: +385915202230
- Email: valerija.bralic.lang@gmail.com
Study Locations
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-
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Zagreb, Croatia
- Recruiting
- Association of teachers in general practice / family medicine
-
Contact:
- Valerija Lang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Totally 100 of patients with type 2 diabetes mellitus diagnosed at least one year prior to study entry, aged ≥40 years, both sexes, treated in primary care, with no isulin in therapy and with clinical suspicion of hypoglycemia or with disproprtion in actual glycemia na haemoglobin A1c findings will be included.
Description
Inclusion Criteria:
- T2DM diagnosed at least one year prior to study entry
- no insulin in therapy
- patients' ability to understand and answer the questionnaire by themselves
- signed informed consent
Exclusion Criteria:
- known coagulopathy
- oral anticoagulants in therapy
- skin disease that enables continuous glucose monitor device application
- febrile illness
- patient's inability to physically visit a general practitioners office
- patient's inability to answer the questionnaire by themselves
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Valerija Lang, Association of teachers in general practice / family medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Anticipated)
September 30, 2017
Study Completion (Anticipated)
October 7, 2017
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 17, 2017
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 17, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DNOOM1072014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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