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Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

NCT ID: NCT00874809

Last Updated: 2013-08-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-12-31

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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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insulin pump DM Type 2 CGMS basal rate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Treatment

There is only one arm for this study using lispro insulin administered by insulin pump.

Group Type OTHER

CGMS with an insulin pump using rapid acting insulin

Intervention Type DEVICE

To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin

Interventions

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CGMS with an insulin pump using rapid acting insulin

To determine basal changes subject will wear a CGMS with an insulin pump infusing rapid acting insulin

Intervention Type DEVICE

Other Intervention Names

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Continuous Glucose Monitoring System (CGMS)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Animas Corporation

INDUSTRY

Sponsor Role collaborator

Diabetes Care Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Allen B. King, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allen B King, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Care Center

Locations

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Diabetes Care Center

Salinas, California, United States

Site Status

Countries

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United States

Other Identifiers

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1799

Identifier Type: -

Identifier Source: org_study_id