Recruiting

Insulin Dosing

Sponsor:

Diabetes Care Center

Code:

NCT01045954

Conditions

Diabetes Mellitus Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lispro Insulin and glargine insulin

Study Details

Brief summary:

This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas. Subjects will be evaluated using continuous glucose monitoring.

Conditions

Diabetes Mellitus Type 1

Study ID

NCT01045954

Start date

Jan, 2010

Status verified date

Jan, 2010

Completion date

Oct, 2010

Anticipated

Primary completion date

Aug, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: >17 years
  • Type 1 diabetes
  • Diabetes duration > 3 months
  • On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks
  • HbA1c <9.0%
  • Stable HbA1c in the proceeding 3 months (i.e., change <1%)
  • Demonstrated adherence to visits and instructions
  • Attend a class in meal carbohydrate content estimation or have demonstrated knowledge of carbohydrate counting

Exclusion Criteria:

  • Major stress event during or for 6 weeks before the evaluation
  • Taking a medication that can alter insulin sensitivity
  • Within one week of menses
  • Unstable eating or activity pattern
  • Pregnancy
  • Weight gain of > 1.5 kg during the preceding 3 months
  • Serum creatinine of >1.5 mg/dl
  • Active liver disease
  • Evidence of autonomic neuropathy, especially gastroparesis
  • Any antidiabetic medication other than insulin
  • Treatment with continuous subcutaneous insulin infusion

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Lispro Insulin and glargine insulin

Continuous glucose sensor will be inserted. Subject will be on an isocaloric diet and CGM downloaded daily. Insulin basal and bolus will be adjusted based upon treatment goals until goals reached

Primary outcome measure

  • Determine the mean value for the slop between the variables of total daily dose versus total basal dose. [ Time Frame: Two weeks ]

Central Contacts and Locations

Central contacts

Gary W Wolfe, RN

831-769-9355gwolfe@diabetescarecenter.com

Locations

Diabetes Care Center

Recruiting

Salinas, California, United States, 93901

Contacts

Gary S Wolfe, RN

831-769-9355gwolfe@diabetescarecenter.com

Principal Investigator:

Allen B King, MD

More Information

Sponsor

Diabetes Care Center

Last update posted

Jan 11, 2010

Last verified

Jan, 2010

Keywords

  • diabetes mellitus type 1
  • continuous glucose monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Diabetes Care Center on 2010-01-11.