Type 2 Diabetes MellitusPC-COSMONCT03253237
Primary Care - Continuous Glucose Monitoring
An observational study of Type 2 Diabetes Mellitus and Continuous Glucose Monitoring, run by University of Zagreb at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Continuous Glucose Monitoring
- What is being tested?
- continuous glucose monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Aug 2017to 7 Oct 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Association of teachers in general practice / family medicine
Zagreb
Valerija Lang
About this study
Official title: 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.
Read the 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.
- Being tested
- continuous glucose monitoring (CGM)
- Keywords
- Glycemic variability, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoring (CGM)Device
Also called iPro™2 Medtronic
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion7 Oct 2017 (estimated)
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 Type 2 Diabetes MellitusStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Association of teachers in general practice / family medicine
- Responsible party
- Principal investigator, Valerija Bralic Lang, University of Zagreb
- Investigators
- Valerija Lang, Principal investigator, Association of teachers in general practice / family medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253237
- Sponsor's protocol ID
- DNOOM1072014
- Acronym
- PC-COSMO
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32151247
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Patients With Diabetes Mellitus Type 2 in Primary Care
- ClinicalTrials.gov ID
- NCT03253237
- Acronym / sponsor ID
- PC-COSMO / DNOOM1072014
- Keywords
- Glycemic variability, Hypoglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- Association of teachers in general practice / family medicine
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 7 Oct 2017 (estimated)
- First posted
- 17 Aug 2017 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| continuous glucose monitoring (CGM)Also: iPro™2 MedtronicA 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. | Device | – |
Primary outcome
Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 32151247Baretic 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.
- 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.
Valerija Lang principal investigator
Association of teachers in general practice / family medicine
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 Type 2 Diabetes Mellitus and Continuous Glucose Monitoring, run by University of Zagreb at 1 site in Croatia.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerija Lang, PhD (+385915202230, valerija.bralic.lang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device (time frame: 7 days). 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 NCT03253237, 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 22 Aug 2017.