Status:
COMPLETED
Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study
Lead Sponsor:
Diabetes Care Center
Collaborating Sponsors:
Animas Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 dia...
Detailed Description
Subjects will be taught CHO counting after which they will be introduced to an insulin pump. They will wear the insulin pump for three weeks to adjust to the pump and its functions. Then the subject w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Type 2 diabetes \> 3month duration
- Age 18
- Hb A1C \<12%
- On any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment
- Normal creatine
- Negative for GAD antibodies
- SMBG \>4/d and willing/able to comply with study requirements
- Demonstrated adherence to visits and instructions.
- Exclusion Criteria
- Severe hypoglycemic during the last month
- Severe cardiac, pulmonary or cerebral disease
- Demonstrated non compliance with clinical recommendations
- Pregnancy, nursing or women who could potentially become pregnant
- Presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of CGM sensor or pump
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00874809
Start Date
March 1 2009
End Date
December 1 2011
Last Update
August 27 2013
Active Locations (1)
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1
Diabetes Care Center
Salinas, California, United States, 93901