Clinical trial NCT00874809: Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study
Official title: A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin pump
DM Type 2
CGMS
basal rate
Lead sponsor: Diabetes Care Center
Sponsor class: INDUSTRY
Collaborators: name: Animas Corporation
First posted: 2009-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: week six of study
Secondary outcomes:
measure: What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong
timeFrame: week 6 of study
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Diabetes Care Center
state: California
Study officials:
affiliation: Diabetes Care Center
name: Allen B King, MD
role: PRINCIPAL_INVESTIGATOR
References: