Examining The Role of CGM in T2DM

The study will enroll and follow 90 participants for 187 days at two sites. Participants
will be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the
SMBG based intervention (Group 2). Group 1 will receive care based upon the results of their
CGM data while group 2 will receive care based upon traditional self-monitoring blood
glucose (SMBG values). The clinical management algorithm will be utilized to guide the care
of all subjects. All study participants will receive the iPro 2 devices (Medtronic Minimed,
Northridge, CA 91325) to collect glucose measurements during five 1 week periods beginning
on Day 0, Day 45, Day 90, Day 135 and Day 180. Laboratory measures of glucose control (HbA1c
and FPG) and quality of life outcomes will be evaluated at Day 0, Day 90 and Day 187.

The iPro2 device is FDA approved for sale in the US and is a commercial product. The iPro2
digital recorder is intended to continuously record interstitial glucose levels in persons
with diabetes mellitus. The iPro 2 is intended to be worn for intermittent periods to
uncover glycemic variability and patterns. The data obtained can then be used to maximum
treatment strategies to improve patient outcomes. The advantage to the iPro 2 is that it is
blinded and will not be influenced by the patient.

The Enlite sensor, is an investigational device, is a 6 day sensor. The subjects in this
study will wear the Enlite sensor for a 6 day monitoring period. The Enlite sensor is
CE-marked and available for sale in over 50 countries and is currently seeking FDA approval.

CareLink iPro Clinical Therapy Management Software is part of the iPro2 CGM system. The
Carelink iPro Clinical Software is intended to support clinical trials. This internet based
software allows data to be viewed and easily evaluated by physicians. A PC links to Carelink
iPro Clinical via the Internet and allows the user to upload data from Medtronic Diabetes
iPro2 devices. Because the algorithm proposed in this protocol has been programed into the
Software, this is an investigational product.

Adult individuals 18-70 years of age, diagnosed with T2DM who are currently being treated in
the Principal Investigators or referring physicians practice with a HbA1c between 7.5-9.0%.

Inclusion Criteria:

- A subject is eligible for the study if all of the following criteria are met:

1. Provide written informed consent prior to enrollment

2. Is male or female between 18-70 years old

3. Has been treated by the Principal Investigator or referring physician in the
same practice.

4. Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic
medications, on a stable dose for 90 days prior to screening.

5. Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.

6. Currently performs self-monitoring blood glucose checks at least 3 times per
week.

7. Ability to adhere to protocol requirements.

Exclusion Criteria:

- 1. Has Type 1 Diabetes or Gestational Diabetes

2.Is pregnant or planning to become pregnant during the course of the study.

3.Current use of any insulin or history of insulin use in the last 6 months.

4.An acute coronary or cerebrovascular event in the previous 3 months.

5.Any planned surgery during the course of the study.

6.Current continuous renal replacement therapy.

7.BMI ≥ 45 kg/m^2

8.Current oral or injectable steroid use.

9.Any previous history Continuous Glucose Monitoring use by any device or
manufacturer.

10.Has a serious or unstable medical or psychological condition which, in the opinion
of the investigator, would compromise the subject's safety or successful
participation in the study.