Primary Care - Continuous Glucose Monitoring
PC-COSMO
Continuous Glucose Monitoring in Patients With Diabetes Mellitus Type 2 in Primary Care
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2017
CompletedAugust 22, 2017
August 1, 2017
2 months
August 14, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device
7 days
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Association of teachers in general practice / family medicine
Zagreb, Croatia
Related Publications (1)
Baretic M, Bralic Lang V. Hypoglycemia in patients with type 2 diabetes treated with oral antihyperglycemic agents detected by continuous glucose monitoring: a multi-center prospective observational study in Croatia. BMC Endocr Disord. 2020 Mar 10;20(1):35. doi: 10.1186/s12902-020-0518-5.
PMID: 32151247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerija Lang
Association of teachers in general practice / family medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Valerija Bralic Lang, MD, FP, PhD
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 17, 2017
Study Start
August 1, 2017
Primary Completion
September 30, 2017
Study Completion
October 7, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08