Internet Monitoring vs Medication to Control Blood Sugar in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize
      health problems and complications. One way for patients to notify doctors and receive
      feedback about their blood sugar management is through an online system. As Internet-based
      glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators
      hypothesize that IBGMS is effective as an intervention even when limiting feedback to
      non-medicine related changes.
    

Detailed description: 
      1. Purpose:

           To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in
           the absence of medication changes.

        2. Hypothesis:

           IBGMS without medication changes is comparable to conventional medication at reducing
           HbA1c levels over 8% in patients with T2DM.

        3. Justification:

           Patients with T2DM having elevated HbA1c levels may be prescribed additional medications
           to help manage their blood sugar levels, which include oral hypoglycemic agents and/or
           insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an
           opportunity to determine whether if this system could be used as an alternative to
           medication.

           The benefits would include reduced side effects as a result of substituting for the
           effects of medication, as well as reduced financial costs associated with acquiring
           medication.

           Considering that IBGMS increases the frequency at which patients receive feedback to
           change medications as compared to typical treatment, the risk is as typical for a
           patient opting for no medication changes for the same period of time.

        4. Objectives: The primary end-point is to determine if patients using IBGMS have reduced
           HbA1c values at followup, and to compare the reduction to the control group on typical
           medications.

        5. Research Method: 120 patients with T2DM satisfying the inclusion criteria will be
           recruited and have baseline HbA1c established through regular lab blood tests. They will
           be randomized into one of two groups, one that will be trained to use IBGMS and one
           control group going on an appropriate additional medication.

           The IBGMS group will be asked to report their blood sugars to their endocrinologist
           biweekly and receive feedback for each report. No medication changes will be offered in
           the feedback, but lifestyle or dietary recommendations may be included.

           The control group will be asked to take their new medications as indicated by their
           endocrinologist.

           Both groups will have followup visits with their endocrinologist at 3 and 6 months, and
           will also have blood tests done at those time points checking their HbA1c levels.

           The effectiveness of both interventions will be evaluated individually and against each
           other.

           For the IBGMS group, a rescue secondary endpoint occurs if a subject maintains an HbA1c
           level at or greater than 8% after 3 months; the subject will be withdrawn from the study
           and put under standard care.

        6. Statistical Analysis: The sample size was calculated to be 120 by estimating mean
           differences and standard deviations using data from previous studies. For the
           calculation the statistical power was 0.80 and alpha of 0.05.
    

Intervention name(s): Internet-Based Glucose Monitoring System; Normal Medication Positive Control
Intervention type(s): Other; Drug
Other intervention name(s): Internet Blood Glucose Monitoring System; Remote Blood Glucose Monitoring System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Internet-Based Glucose Monitoring System; Type 2 Diabetes