Diabetes Mellitus Type 1
Conditions
Keywords
diabetes mellitus type 1, continuous glucose monitoring
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.
Interventions
DRUGLispro 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
Sponsors
Diabetes Care Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the mean value for the slop between the variables of total daily dose versus total basal dose. | Two weeks |
Secondary
| Measure | Time frame |
|---|---|
| Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor | Two weeks |
Countries
United States
Contacts
Primary ContactGary W Wolfe, RN
Outcome results
None listed