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OpenTrials
Completed

NCT Number: NCT00874809

Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Care Center

Salinas, California, 93901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGMS with an insulin pump using rapid acting insulin

Device

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

Other names: Continuous Glucose Monitoring System (CGMS)

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Diabetes Care Center

Industry

Collaborators

  • Animas Corporation

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 3, 2009
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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