Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, continuous glucose, basal insulin
Brief summary
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.
Detailed description
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.
Interventions
None listed
Sponsors
Medtronic
Diabetes Care Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Age 18 years and above * Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/- glinides and basal insulin analogs * A1C 10% or below * Capable of self monitoring glucose at least 4 x a day * Previously compliant with clinical recommendations * Fasting blood glucose \<110mg/dl average for 3 consecutive days * BMI \<45 kg/m
Exclusion criteria
* Urinary ketosis * Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode * Currently participating in another clinical trial * Using rapid insulin insulin * Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control * Significant liver or heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time CGM glucose is <70mg/dl | the subject will be followed for 9 days | The percentage of time CGM glucose is \<70 mg/dl during the basal glucose evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time CGM glucose is <40 mg/dl | the subject will be followed for 9 days | The percentage of time the CGM glucose is \<40 mg/dl |
| Determined hypoglycaemic episodes | the subject will be followed for 9 days | The percentage of subjects who perceived all CGM determined hypoglycaemic episodes |
| Weight gain | the subject will be followed for 9 days | The mean weight gain since initiating basal insulin fromo retrospectively gathered data. |
Countries
United States
Outcome results
None listed