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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: February 27, 2012
Last verified: February 2012
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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 ]

Enrollment: 30
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
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

Locations
United States, California
Diabetes Care Center
Salinas, California, United States, 93901
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: Allen B. King, MD, Principal Investigator, Diabetes Care Center
ClinicalTrials.gov Identifier: NCT00874809     History of Changes
Other Study ID Numbers: 1799
Study First Received: April 1, 2009
Last Updated: February 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetes Care Center:
insulin pump
DM Type 2
CGMS
basal rate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013