Clinical trial NCT01548222: CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target
Official title: CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
continuous glucose
basal insulin
Lead sponsor: Diabetes Care Center
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2012-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the Diabetes Care Center clinic

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of time CGM glucose is <70mg/dl
timeFrame: the subject will be followed for 9 days
Secondary outcomes:
measure: Percentage of time CGM glucose is <40 mg/dl
timeFrame: the subject will be followed for 9 days
measure: Determined hypoglycaemic episodes
timeFrame: the subject will be followed for 9 days
measure: Weight gain
timeFrame: the subject will be followed for 9 days
Other outcomes:
Locations:
city: Salinas
country: United States
facility: Diabetes Care Center
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.