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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lispro Insulin and glargine insulin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No