Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

Study Overview
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Brief Summary
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The main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes

Detailed Description
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Subjects will be taught CHO counting after which they will be introduced to an insulin pump. They will wear the insulin pump for three weeks to adjust to the pump and its functions. Then the subject will wear a Continuous Glucose Monitoring System to determine rate changes needed to achieve short-term near normal glucose control. The primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. The secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong.

Official Title
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A Pilot Study to Explore Basal Insulin Dosing Requirements in Patients With Type 2 Diabetes Treated With Insulin Pump Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: CGMS with an insulin pump using rapid acting insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes > 3month duration Age 18 Hb A1C <12% On any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment Normal creatine Negative for GAD antibodies SMBG >4/d and willing/able to comply with study requirements Demonstrated adherence to visits and instructions. Exclusion Criteria Severe hypoglycemic during the last month Severe cardiac, pulmonary or cerebral disease Demonstrated non compliance with clinical recommendations Pregnancy, nursing or women who could potentially become pregnant Presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of CGM sensor or pump

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insulin Treatment<br>There is only one arm for this study using lispro insulin administered by insulin pump. | Device: CGMS with an insulin pump using rapid acting insulin<br>* To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin<br>* Other names: Continuous Glucose Monitoring System (CGMS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What are the mean number of changes in the basal infusion rate(change is defined as any alternation in the basal rate >0.1 U/hr) and what are the mean differences and mean duration (hrs) of these changes. |  | week six of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong |  | week 6 of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin pump, DM Type 2, CGMS, basal rate