Blood Monitoring and Data Acquisition and Utilization in Patients With Type 2 Diabetes Treated With Insulin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In
      order to prevent complications, patients need to monitor and control their blood sugar
      levels. In addition, they may need to have an ongoing communication with their doctor in
      order to modify treatment. In this study the investigators wish to compare the benefits of
      continuous glucose monitoring system (CGMS) to an internet-based glucose monitoring system
      (IBGMS). The investigators also want to determine whether the frequency of blood glucose
      testing affects blood glucose control and to see whether the benefits of CGMS and IBGMS are
      independent of testing frequency.
    

Detailed description: 
      In this current study, the investigators wish to test several hypotheses: whether the
      frequency of SMBG is correlated with HbA1c, whether the knowledge that strips are being
      counted affects HbA1c, whether the reduction of HbA1c when using an IBGMS is independent of
      the frequency of testing, and whether there is a difference between IBGMS and CGMS in HbA1c
      reduction.

      The investigators will recruit 100 patients with type 2 diabetes who satisfy the
      inclusion/exclusion criteria. For the first visit, the patients will be immediately
      randomized into four groups. One group will be testing 3 times a day (SMBG). The second group
      will be similar to the SMBG group except they will know that we are counting the frequency of
      testing (SMBG With Knowledge). The third group will use an IBGMS and the fourth group will
      use a CGMS. During the first visit, we will teach the patient how to use the programs and
      machinery for their group. All four groups will be asked to follow the protocol and to visit
      their doctor in 3 month intervals for 6 months along with completed laboratory blood test
      results.

      For the SMBG and the SMBG With Knowledge group, each will be given a new meter and be asked
      to test 3 times a day. They will also be required to keep a diary of their SMBG levels. The
      difference between the two is that the SMBG With Knowledge group will know that we are
      counting strips. The SMBG group will believe that we are testing a new meter and will not
      know that the SMBG With Knowledge group exists. This deception is necessary to test the
      experimental effect of if the patient knows that we are counting the frequency of testing,
      does that affect the frequency that they are testing. The investigators will tell the SMBG
      group that we are testing the accuracy of a new meter and they should test 3 times a day.

      For the CGMS and IBGMS group, they will also be counting the frequency of blood glucose
      testing to see whether the benefits from both are independent of the number of tests.
      Furthermore, we wish to compare the these two methods of blood glucose monitoring. Both
      groups will have to upload their data onto the internet and communicate with their doctor
      every 2 weeks using a secure online web site.

      At the end of 3 and 6 months, we will collect the frequency of testing from each group to
      determine whether increased glycemic control correlates with increased testing. We will also
      collect their SMBG diaries to see whether the written data correlates with the data on their
      meter. The investigators will also be comparing a measure of their blood glucose levels for
      each group and determining the effectiveness of CGMS and IBGMS.
    

Intervention name(s): Remote Blood Glucose Monitoring; Continuous Glucose Monitoring; SMBG; SMBG With Knowledge
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.; The use of CGMS (Sensor, receiver, transmitter) (Medtronic Diabetes) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will not receive feedback or suggestion based on the uploaded glucose data.; The SMBG patients will be told that we are testing a new meter to check the accuracy of the meter. They will be asked to test at least 3 times a day and to keep a written diary of their sugar levels. The SMBG group will not know that we are counting strips and can not know about the SMBG With Knowledge group as it may bias the frequency that they test.; The SMBG With Knowledge patients will be given a new meter and will be asked to test at least 3 times a day and to keep a written diary of their sugar levels. We will inform this group that we are measuring the frequency of SMBG testing.
Other intervention name(s): Internet Blood Glucose Monitoring System; Sensors, CGMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Remote Blood Glucose Monitoring System,; Continuous Glucose Monitoring System,; Self Monitoring Blood Glucose,; Strip Counting,; Type 2 Diabetes