Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.
In many clinical trials, basal insulin is titrated to only a fasting glucose goal. The usual final dose is >0.4U/kg. In carefully CGM monitored/titrated studies in both basal insulin alone or in pump-treated T2DM, we have found the basal insulin dose to be <0.3U/kg. This suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. This study will examine that issue.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time CGM glucose is <70mg/dl | The percentage of time CGM glucose is <70 mg/dl during the basal glucose evaluation | the subject will be followed for 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time CGM glucose is <40 mg/dl | The percentage of time the CGM glucose is <40 mg/dl | the subject will be followed for 9 days |
| Determined hypoglycaemic episodes | The percentage of subjects who perceived all CGM determined hypoglycaemic episodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects will be recruited from the Diabetes Care Center clinic
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Care Center | Salinas | California | 93901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19515182 | Background | Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x. | |
| 17924873 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| the subject will be followed for 9 days |
| Weight gain | The mean weight gain since initiating basal insulin fromo retrospectively gathered data. | the subject will be followed for 9 days |
| Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x. |
| 19885117 | Result | Strange P. Treat-to-target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):540-8. doi: 10.1177/193229680700100412. |
| 19120433 | Result | King AB. Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study. Diabetes Obes Metab. 2009 Jan;11(1):69-71. doi: 10.1111/j.1463-1326.2008.01014.x. |
| D004700 | Endocrine System Diseases |