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

Study Overview
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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.

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.

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

Conditions
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Diabetes Mellitus Type 1

Intervention / Treatment
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* Drug: Lispro Insulin and glargine insulin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the mean value for the slop between the variables of total daily dose versus total basal dose. |  | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor |  | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus type 1, continuous glucose monitoring