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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lispro Insulin and glargine insulin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the mean value for the slop between the variables of total daily dose versus total basal dose. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the slope between the other variables: weight, total daily dose, total basal dose, insulin correction carbohydrate rate, correction factor | Two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gary W Wolfe, RN | Contact | 831-769-9355 | gwolfe@diabetescarecenter.com |
| Name | Affiliation | Role |
|---|---|---|
| Allen B. King, MD | Diabetes Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Care Center | Recruiting | Salinas | California | 93901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 19888378 | 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. | |
| 19888377 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 17, 2011 | |
| Reset | Jul 14, 2011 | |
| Release | Aug 23, 2013 | |
| Reset | Oct 27, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2011 | Jul 14, 2011 | |||
| Aug 23, 2013 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Background |
| 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. |
| Background | 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 |
| Oct 27, 2013 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |