Type 2 Diabetes Mellitus
Conditions
Keywords
insulin pump, DM Type 2, CGMS, basal rate
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 diabetes
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 will wear a Continuous Glucose Monitoring System to determine rate changes needed to achieve short-term near normal glucose control. The primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. The secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong.
Interventions
DEVICECGMS with an insulin pump using rapid acting insulin
To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin
Sponsors
Animas Corporation
Diabetes Care Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes. | week six of study |
Secondary
| Measure | Time frame |
|---|---|
| What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong | week 6 of study |
Countries
United States
Outcome results
None listed