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
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Mar 2009
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 27, 2013
August 1, 2013
2.8 years
April 1, 2009
August 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Insulin Treatment
OTHERThere is only one arm for this study using lispro insulin administered by insulin pump.
Interventions
To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diabetes Care Centerlead
- Animas Corporationcollaborator
Study Sites (1)
Diabetes Care Center
Salinas, California, 93901, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allen B King, MD
Diabetes Care Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 3, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 27, 2013
Record last verified: 2013-08