Clinical trial NCT01045954: A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
Official title: A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 1
Keywords: diabetes mellitus type 1
continuous glucose monitoring
Lead sponsor: Diabetes Care Center
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Subjects with stable type 1 diabetes mellitus on multiple daily insulin injections including basal and bolus will be selected in order to determine the correct insulin dosing formulas. Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet. Subjects will have the CGMS downloaded daily and the insulin doses adjusted if necessary. Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG. subjects will be on lispro and glargine insulin. Basal insulin will be once a day.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the mean value for the slop between the variables of total daily dose versus total basal dose.
timeFrame: Two weeks
Secondary outcomes:
measure: Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor
timeFrame: Two weeks
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Diabetes Care Center
state: California
Study officials:
affiliation: Diabetes Care Center
name: Allen B. King, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh J, Roberts R. Pumping Insulin. 3rd Edition, San Diego, Torrey Pines Press. 2000
citation: 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
citation: 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.
citation: 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.
citation: 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