- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01045954
A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
January 8, 2010 updated by: Diabetes Care Center
This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas.
Subjects will be evaluated using continuous glucose monitoring.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Subjects with stable type 1 diabetes mellitus on multiple daily insulin injections including basal and bolus will be selected in order to determine the correct insulin dosing formulas.
Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet.
Subjects will have the CGMS downloaded daily and the insulin doses adjusted if necessary.
Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG.
subjects will be on lispro and glargine insulin.
Basal insulin will be once a day.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gary W Wolfe, RN
- Phone Number: 831-769-9355
- Email: gwolfe@diabetescarecenter.com
Study Locations
-
-
California
-
Salinas, California, United States, 93901
- Recruiting
- Diabetes Care Center
-
Contact:
- Gary S Wolfe, RN
- Phone Number: 831-769-9355
- Email: gwolfe@diabetescarecenter.com
-
Principal Investigator:
- Allen B King, MD
-
Sub-Investigator:
- Dawn Clark, NP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: >17 years
- Type 1 diabetes
- Diabetes duration > 3 months
- On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks
- HbA1c <9.0%
- Stable HbA1c in the proceeding 3 months (i.e., change <1%)
- Demonstrated adherence to visits and instructions
- Attend a class in meal carbohydrate content estimation or have demonstrated knowledge of carbohydrate counting
Exclusion Criteria:
- Major stress event during or for 6 weeks before the evaluation
- Taking a medication that can alter insulin sensitivity
- Within one week of menses
- Unstable eating or activity pattern
- Pregnancy
- Weight gain of > 1.5 kg during the preceding 3 months
- Serum creatinine of >1.5 mg/dl
- Active liver disease
- Evidence of autonomic neuropathy, especially gastroparesis
- Any antidiabetic medication other than insulin
- Treatment with continuous subcutaneous insulin infusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
Time Frame: Two weeks
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor
Time Frame: Two weeks
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Walsh J, Roberts R. Pumping Insulin. 3rd Edition, San Diego, Torrey Pines Press. 2000
- Bode BW. Insulin Pump Therapy. In, Therapy for diabetes Mellitus and Related Disorders, fourth edition, Lebovitz H. Ed, Alexandria, VA, American Diabetes Association, 2004, p224-231
- King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. doi: 10.1177/193229680700100107.
- King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. doi: 10.1177/193229680700100106.
- Davidson PC, Hebblewhite HR, Bode BW, et al. Statistically based CSII parameters correction factor, CF (1700 rule) carbohydrate-to-insulin ratio, CIR (2.8 rule) and basal-to-total ration. Diabetes Technol Ther. 2003; 3:237
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ANTICIPATED)
August 1, 2010
Study Completion (ANTICIPATED)
October 1, 2010
Study Registration Dates
First Submitted
January 7, 2010
First Submitted That Met QC Criteria
January 8, 2010
First Posted (ESTIMATE)
January 11, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 11, 2010
Last Update Submitted That Met QC Criteria
January 8, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCC 02-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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