Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Device: CGMS with an insulin pump using rapid acting insulin

• Registration Number: NCT00874809
• Lead Sponsor: Diabetes Care Center

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin Treatment	CGMS with an insulin pump using rapid acting insulin	There is only one arm for this study using lispro insulin administered by insulin pump.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Diabetes Care Center; 🇺🇸 Salinas, California, United States