Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874809
• Other study ID #: 1799
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: August 23, 2013
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Diabetes Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• CGMS 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

Locations

Country	Name	City	State
United States	Diabetes Care Center	Salinas	California

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Care Center	Animas Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No