Secondary Care - Continuous Glucose Monitoring
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

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 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.
    

Intervention name(s): continuous glucose monitoring (CGM) iPro™2 Medtronic
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
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 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.
      
Keywords: continuous glucose monitoring; glycemic variability; hypoglycemia