NCT01045954

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

January 7, 2010

Last Update Submit

January 8, 2010

Conditions

Diabetes Mellitus Type 1

Keywords

diabetes mellitus type 1continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Determine the mean value for the slop between the variables of total daily dose versus total basal dose.

    Two weeks

Secondary Outcomes (1)

  • Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor

    Two weeks

Interventions

Lispro Insulin and glargine insulinDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Care Center

Salinas, California, 93901, United States

RECRUITING

Related Publications (5)

  • Walsh J, Roberts R. Pumping Insulin. 3rd Edition, San Diego, Torrey Pines Press. 2000

    BACKGROUND

  • Bode BW. Insulin Pump Therapy. In, Therapy for diabetes Mellitus and Related Disorders, fourth edition, Lebovitz H. Ed, Alexandria, VA, American Diabetes Association, 2004, p224-231

    BACKGROUND

  • King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. doi: 10.1177/193229680700100107.

    PMID: 19888378BACKGROUND

  • King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. doi: 10.1177/193229680700100106.

    PMID: 19888377BACKGROUND

  • Davidson PC, Hebblewhite HR, Bode BW, et al. Statistically based CSII parameters correction factor, CF (1700 rule) carbohydrate-to-insulin ratio, CIR (2.8 rule) and basal-to-total ration. Diabetes Technol Ther. 2003; 3:237

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin LisproInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

  • Allen B. King, MD

    Diabetes Care Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary W Wolfe, RN

CONTACT

831-769-9355gwolfe@diabetescarecenter.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 11, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

January 11, 2010

Record last verified: 2010-01

Locations

US(1)