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A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Diabetes Care Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Diabetes Care Center
ClinicalTrials.gov Identifier:
NCT01045954
First received: January 7, 2010
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 1
 Drug: Lispro Insulin and glargine insulin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Diabetes Care Center:

Primary Outcome Measures:
  • Determine the mean value for the slop between the variables of total daily dose versus total basal dose. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lispro Insulin and glargine insulin
    Continuous glucose sensor will be inserted. Subject will be on an isocaloric diet and CGM downloaded daily. Insulin basal and bolus will be adjusted based upon treatment goals until goals reached
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045954

Contacts
Contact: Gary W 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
Investigators
Principal Investigator: Allen B. King, MD Diabetes Care Center
  More Information

Publications:
King A, Armstrong D. 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; 1:36-41
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

Responsible Party: Allen B. King, MD, Diabetes Care Center
ClinicalTrials.gov Identifier: NCT01045954     History of Changes
Other Study ID Numbers: DCC 02-09
Study First Received: January 7, 2010
Last Updated: January 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Diabetes Care Center:
diabetes mellitus type 1
continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin LISPRO
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013