Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

Diabetes Care Center

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: CGMS with an insulin pump using rapid acting insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00874809

1799

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Insulin Treatment

Other group

Description:

There is only one arm for this study using lispro insulin administered by insulin pump.

Treatment:

Device: CGMS with an insulin pump using rapid acting insulin