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 Locations

  • United States
    • California
      • Salinas, California, United States, 93901
        • Recruiting
        • Diabetes Care Center
        • Contact:
        • 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

Diabetes Care Center

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

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

Keywords

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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