Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting: A Long-term, Prospective, Observational Registry (SIMPLE)

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: V-Go™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed type 2 diabetes mellitus for at least 12 months. Must be and have been in stable treatment for at least a month within each of the following diabetes medication regimens: OADs only, OADs in combination with either exenatide, pramlintide, liraglutide (collectively termed incretin mimetics) without receiving insulin, Once or twice daily injection of an intermediate or long acting insulin (insulin NPH, insulin detemir or insulin glargine) with or without OADs and/or an incretin. One to three daily injections of premix insulin (human insulin 70/30, insulin lispro 75/25 or insulin aspart 70/30) with or without OADs and/or an incretin. Any insulin therapy with three or more insulin injections a day with or without OADs (MDI). Must be willing to self monitor glucose at least twice a day. The patient must be willing and able in the opinion of the investigator to try V-Go as therapy. Age between 21 and 80 years old, inclusive. A1C greater than or equal to 7.0%. Exclusion Criteria: Acute infection with fever. Serum creatinine > 3.0 mg/dl if not on metformin, or if on metformin for females creatinine > 1.4 mg/dl, for males creatinine > 1.5 mg/dl within the last 6 months. Pregnancy, intention to become pregnant or failure to agree to use adequate contraceptive measures during the trial for females of current reproductive potential.Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (pills, patches, implants, or injections), (3) barrier methods (condom, diaphragm) used with spermicide, or (4) intrauterine device (IUD). Contraceptive measures such as Plan B™, for emergency use after unprotected sex, are not acceptable methods for routine use. A lifestyle of abstinence from sexual activity is an acceptable means of contraception. If currently abstinent, the subject must agree to use a double-barrier method as described above if they become sexually active during the study period. Any medical history of malignant melanoma or breast cancer. Medical history of any other cancers within the last five years except adequately treated basal cell carcinoma or cervical carcinoma in-situ. History of alcohol or drug abuse within the last year. Any medical condition that in the opinion of the investigator may preclude safe and successful completion of the trial. Participation in other clinical trials involving receipt of investigational drug that cannot be disclosed within the last 30 days. Unwillingness and/or inability to comply with study procedures. Require regular adjustments or modifications to the basal rate during a 24-hour period, or if the amount of insulin used at meals require adjustments of less-than 2-Unit increments. History of hypersensitivity or hyperreactivity to adhesives.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM patients with A1C<7.0%<br> | Device: V-Go™<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 month | 
| Number of Participants with adverse events. |  | 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 | 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. | 12 month | 
| To describe changes in participants' weight from the beginning to the end of the study. |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
V Go™, Type 2 Diabetes, Insulin, Oral Anti Hypoglycemic Drugs