Diabetes Mellitus Type 2 Basal Insulin Dosing Requirements Study

D

Diabetes Care Center

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Device: CGMS with an insulin pump using rapid acting insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00874809
1799

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Insulin Treatment
Other group
Description:
There is only one arm for this study using lispro insulin administered by insulin pump.
Treatment:
Device: CGMS with an insulin pump using rapid acting insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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