The Efficacy of Guardian Connect to Modify Lifestyle in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It has been demonstrated by many different researches that for patients to work on their
      lifestyle modifications, it is important that the patients know their exact blood glucose
      levels. Unlike the HbA1c which can only be determined at the hospital, improvements in blood
      glucose levels were detected in both the Type 1 Diabetes Mellitus patients who use insulin as
      well as Type 2 Diabetes Mellitus patients with SMBG(self-monitoring of blood glucose) which
      is the method used by patients to measure the blood glucose level at home on their own. Where
      SMBG needed blood to be collected from the fingertips, it has now passed the continuous
      glucose monitoring(CGM) stage where blood drawing is no longer required and is now replaced
      by the real-time CGM(RT-CGM) where blood glucose level can be checked real time. Type 2
      Diabetes Mellitus patients who do not use preprandial rapid insulin were divided into SMBG
      group and intermittent RT-CGM user group and their blood glucose level decrease monitored for
      3 months. After 3 months, HbA1c in SMBG group decreased 0.5% compared to the baseline while
      1.0% decreased in RT-CGM group. The research was extended 40 weeks to make the total research
      period to 52 weeks and the results still showed that there were significant decrease in the
      RT-CGM group. However, up to this day, there are no researches that can show that there are
      additional decrease in the blood glucose level in Type 2 Diabetes Mellitus patients with use
      of RT-CGM in the group where sufficient blood glucose management cannot be achieved through
      use of three oral drug combination therapy to lower the blood glucose level.

      This research seeks to find out if there are any decreases in the blood glucose level by
      using RT-CGM at 6 month period in Type 2 Diabetes Mellitu patient group whose blood glucose
      level cannot significantly be managed after the three oral hypoglycemic agent combination
      therapy.
    

Detailed description: 
      -  Pilot, Prospective, open label, multicenter, 3 arm, randomized, feasibility study

        -  Divided into below three groups iPRo2 only (Control group) / iPRo2 + RT-CGM 1 week
           treatment (Treatment group 1) / iPRo2 + RT-CGM 1 week on /3 weeks off (2 cycles)
           (Treatment group 2)
    

Intervention name(s): Guardian connect; iPro2
Intervention type(s): Device; Device
Intervention description(s): Treatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period.
Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.; Treatment group 1 will go through target lifestyle coaching including diet and exercise and will have 1 session of RT-CGM after which they will undergo 24 weeks of follow-up period.
Treatment group 2 will go through target life coaching including diet and exercise and will have 2 sessions(CGM 1week, 12week after measuring HbA1c) of RT-CGM after which they will undergo 24 weeks of follow-up period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes self-management education