Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

This study has been completed.
Sponsor:
Collaborator:
Animas Corporation
Information provided by (Responsible Party):
Allen B. King, MD, Diabetes Care Center
ClinicalTrials.gov Identifier:
NCT00874809
First received: April 1, 2009
Last updated: August 23, 2013
Last verified: August 2013

April 1, 2009
August 23, 2013
March 2009
December 2011   (final data collection date for primary outcome 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. [ Time Frame: week six of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00874809 on ClinicalTrials.gov Archive Site
What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong [ Time Frame: week 6 of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study
A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
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
Other Name: Continuous Glucose Monitoring System (CGMS)
Insulin Treatment
There is only one arm for this study using lispro insulin administered by insulin pump.
Intervention: Device: CGMS with an insulin pump using rapid acting insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00874809
1799
No
Allen B. King, MD, Diabetes Care Center
Diabetes Care Center
Animas Corporation
Principal Investigator: Allen B King, MD Diabetes Care Center
Diabetes Care Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP