search
Back to results

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

Primary Purpose

Diabetes Mellitus Type 1

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lispro Insulin and glargine insulin
Sponsored by
Diabetes Care Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring diabetes mellitus type 1, continuous glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diabetes Care CenterRecruiting

Outcomes

Primary Outcome Measures

Determine the mean value for the slop between the variables of total daily dose versus total basal dose.

Secondary Outcome Measures

Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor

Full Information

First Posted
January 7, 2010
Last Updated
January 8, 2010
Sponsor
Diabetes Care Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01045954
Brief Title
A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
Official Title
A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Diabetes Care Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
Keywords
diabetes mellitus type 1, continuous glucose monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lispro Insulin and glargine insulin
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary W Wolfe, RN
Phone
831-769-9355
Email
gwolfe@diabetescarecenter.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen B. King, MD
Organizational Affiliation
Diabetes Care Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Care Center
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary S Wolfe, RN
Phone
831-769-9355
Email
gwolfe@diabetescarecenter.com
First Name & Middle Initial & Last Name & Degree
Allen B King, MD
First Name & Middle Initial & Last Name & Degree
Dawn Clark, NP

12. IPD Sharing Statement

Citations:
Citation
Walsh J, Roberts R. Pumping Insulin. 3rd Edition, San Diego, Torrey Pines Press. 2000
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
19888378
Citation
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.
Results Reference
background
PubMed Identifier
19888377
Citation
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.
Results Reference
background
Citation
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
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs