The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia risk, other possible adverse effects and weight changes, as well as to compare these parameters to prior treatment when patients with type 2 diabetes are initiated and treated using V-Go during circumstances as close to normal clinical practice as possible.
Study Type
OBSERVATIONAL
Enrollment
270
Use of Insulin Delivery Device, V-Go, and the effect on A1C for T2DM patients in five categories of baseline oral antidiabetes drug (OAD) use with or without insulin.
The primary objective is to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go use for the whole cohort as well as each of the five categories of baseline treatment.
Time frame: 12 month
Glycemic control is measured by the HbA1C from the beginning of the study to the end.
To describe change of average glycemic control as measured by A1C from baseline to the particular time point of analysis irrespective of treatment, and to describe this change for subjects who are still treated with the V-Go and those who have switched to other therapies.
Time frame: 12 month
To describe the incidence of hypoglycemia in participants as measured by blood glucose of <70 mg/dl.
Occurrence of hypoglycemia confirmed with self monitored plasma referenced glucose measurement \<70 mg/dl.
Time frame: 12 month
Number of Participants with adverse events.
Time frame: 12 month
How well the participants follow their doctors prescriptions for diabetes care.
To describe frequency of self monitoring plasma glucose with V-Go therapy
Time frame: 12 month
To describe insulin dose requirements from the beginning to the end of the study , and concomitant drugs to lower blood glucose.
Some of the insulin dose requirement that will described are: starting dose, dose titration, basal rate selection, dose conversion from previous therapy.
Time frame: 12 month
To describe changes in participants' weight from the beginning to the end of the study.
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San Diego Coastal Endocrinology Group
Chula Vista, California, United States
Nancy J. Bohannon Med. Corp
San Francisco, California, United States
Western Connecticut Health Network, Inc.
Danbury, Connecticut, United States
MEDSOL Clinical Research Center
Port Charlotte, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Albert Johary M.D., P.C.
Dunwoody, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
MidAmerica Diabetes Associates
Wichita, Kansas, United States
MODEL Clinical Research
Baltimore, Maryland, United States
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, United States
...and 15 more locations
Time frame: 12 month