Diabetes Mellitus, Type 2SC-COSMONCT03487887
Secondary Care - Continuous Glucose Monitoring
An observational study of Diabetes Mellitus, Type 2, run by Croatian Society for Endocrinology and Diabology at 1 site in Croatia.
Trial summary
Introduction and objective: The current state of glucose monitoring includes the use of A1C, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose… Read more about this study
- Who is it for?
- Ages 3 to 8 days
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- continuous glucose monitoring (CGM) iPro™2 Medtronic
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 19 Mar 2018to 25 Aug 2021
- 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 3 to 8 days
- All sexes
- No healthy volunteers
- Child
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 secondary care, with no insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and A1C findings will be included.
Who may be able to join
- T2DM diagnosed at least one year prior to study entry
- Only basal 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.
About this study
Official title: Continuous Glucose Monitoring in Patients With Diabetes Mellitus Type 2 in Secondary Care
Introduction and objective: The current state of glucose monitoring includes the use of A1C, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose control. Until very recently, this determination could only be achieved by the attainment of multiple capillary blood glucose determinations each day and/or measuring hemoglobin A1C. Those methods are not accurate in cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings in blood glucose. Our aim is to analyze the benefit of tracking patterns of glucose values by using professional CGM technology used for "blinded" collection of glucose data retrospectively in patients with T2DM in secondary care- diabetologist clinic.
Read the detailed description
STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 diabetologist from four Croatian regions will recruit up to ten subjects of both sexes from May 2018 till the end of May 2019, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with only basal insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and hemoglobin A1c findings. Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol, and high density cholesterol, and low density cholesterol, triglyceride and serum creatinine) and habits data will be collected.
SETTING: Totally 100 of patients will be included. At diabetologist office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days and return it to the office for download. Patients only see the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist who are not familiar to the method will have a short education. 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 SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- continuous glucose monitoring (CGM) iPro™2 Medtronic
- Keywords
- continuous glucose monitoring, 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) iPro™2 MedtronicDevice
A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist not familiar to the method will have a short education on CGM device. 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 SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills 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
Glycemic variability measured by continuous glucose monitor devicein individuals with type 2 diabetes mellitus in secondary care
Measured: 7 days
Secondary outcomes (1)
Hypogliaemia
Hypogliaemia measured by continuous glucose monitor device in individuals with type 2 diabetes mellitus in secondary care
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 posted4 Apr 2018
- Study start19 Mar 2018
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Croatian Society for Endocrinology and Diabology
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Maja Baretić, Croatian Society for Endocrinology and Diabology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487887
- Sponsor's protocol ID
- Program CGM u bolesnika T2DM
- Acronym
- SC-COSMO
- Status last verified
- Aug 2021
- First submitted
- 21 Mar 2018
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. 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 Secondary Care
- ClinicalTrials.gov ID
- NCT03487887
- Acronym / sponsor ID
- SC-COSMO / Program CGM u bolesnika T2DM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- continuous glucose monitoring, glycemic variability, hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Croatian Society for Endocrinology and DiabologyUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 4 Apr 2018 (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 current state of glucose monitoring includes the use of A1C, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose control. Until very recently, this determination could only be achieved by the attainment of multiple capillary blood glucose determinations each day and/or measuring hemoglobin A1C. Those methods are not accurate in cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings in blood glucose. Our aim is to analyze the benefit of tracking patterns of glucose values by using professional CGM technology used for "blinded" collection of glucose data retrospectively in patients with T2DM in secondary care- diabetologist clinic.
Detailed description
STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 diabetologist from four Croatian regions will recruit up to ten subjects of both sexes from May 2018 till the end of May 2019, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with only basal insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and hemoglobin A1c findings. Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol, and high density cholesterol, and low density cholesterol, triglyceride and serum creatinine) and habits data will be collected.
SETTING: Totally 100 of patients will be included. At diabetologist office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days and return it to the office for download. Patients only see the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist who are not familiar to the method will have a short education. 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 SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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 secondary care, with no insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and A1C findings will be included.
Key inclusion criteria (4 listed)
- T2DM diagnosed at least one year prior to study entry
- Only basal 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) iPro™2 MedtronicA CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist not familiar to the method will have a short education on CGM device. 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 SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM. | Device | – |
Primary outcome
Glycemic variability
Time frame: 7 days
Glycemic variability measured by continuous glucose monitor devicein individuals with type 2 diabetes mellitus in secondary care
1 secondary outcome
Hypogliaemia
Time frame: 7 days
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 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mellitus, Type 2, run by Croatian Society for Endocrinology and Diabology 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: finished, as of the sponsor's last update on 13 Sep 2022. 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?
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.
What does the primary outcome measure?
Glycemic variability (time frame: 7 days). It is what the study was designed to measure, not a finding.
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 13 Sep 2022.