Clinical Trial Details

NCT ID: NCT01045954
Date Last Changed: January 8, 2010

Overview

Research Study Summary

A clinical trial to evaluate treatments using Lispro Insulin and glargine insulin for patients with Diabetes Mellitus Type 1

Research Study Title

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

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.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Diabetes Care Center
Duration
7 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
United States California Salinas 93901 Diabetes Care Center
Gary S Wolfe, RN
831-769-9355
gwolfe@diabetescarecenter.com

Allen B King, MD
Principal Investigator

Dawn Clark, NP
Sub-Investigator

Contact

Gary W Wolfe, RN
831-769-9355
E-mail:

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