Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study - Full Text View

Sponsors and Collaborators:	Diabetes Care Center Animas Corporation
Information provided by:	Diabetes Care Center
ClinicalTrials.gov Identifier:	NCT00874809

Purpose

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

Condition	Intervention
Type 2 Diabetes Mellitus	Device: CGMS with an insulin pump using rapid acting insulin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Diabetes Care Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	10
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874809

Contacts

Contact: Gary S Wolfe, RN

831-769-9355

gwolfe@diabetescarecenter.com

Locations

United States, California
Diabetes Care Center	Recruiting
Salinas, California, United States, 93901
Contact: Gary S Wolfe, RN 831-769-9355 gwolfe@diabetescarecenter.com
Principal Investigator: Allen B King, MD
Sub-Investigator: Dawn Clark, NP

Sponsors and Collaborators

Diabetes Care Center

Animas Corporation

Investigators

Principal Investigator:

Allen B King, MD

Diabetes Care Center

More Information

No publications provided

Responsible Party:	Diabetes Care Center ( Allen B. King, MD )
Study ID Numbers:	1799
Study First Received:	April 1, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00874809 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Diabetes Care Center:

insulin pump
DM Type 2
CGMS
basal rate

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 11, 2009