Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

Diabetes Care Center30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

CGMS with an insulin pump using rapid acting insulinDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Diabetes Care Center

Salinas, California, United States

Outcomes

Primary Outcomes

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.

Time frame: week six of study

Secondary Outcomes

What mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by King and Armstrong

Time frame: week 6 of study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.