Clinical Trial Details

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


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


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.

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Recruitment Details

Both Male and Female
18 and up
Overall Status
Lead Sponsor
Diabetes Care Center
7 Months
Facility Type


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

Allen B King, MD
Principal Investigator

Dawn Clark, NP


Gary W Wolfe, RN

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