Overview

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

Status:
Unknown status
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Diabetes Care Center
Treatments:
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Globin Zinc
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