CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target

Diabetes Care Center20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Diabetes Care Center

Salinas, California, United States

Outcomes

Primary Outcomes

Percentage of time CGM glucose is <70mg/dl

The percentage of time CGM glucose is \<70 mg/dl during the basal glucose evaluation

Time frame: the subject will be followed for 9 days

Secondary Outcomes

Percentage of time CGM glucose is <40 mg/dl

The percentage of time the CGM glucose is \<40 mg/dl

Time frame: the subject will be followed for 9 days

Determined hypoglycaemic episodes

The percentage of subjects who perceived all CGM determined hypoglycaemic episodes

Time frame: the subject will be followed for 9 days

Weight gain

The mean weight gain since initiating basal insulin fromo retrospectively gathered data.

Time frame: the subject will be followed for 9 days

Data from ClinicalTrials.gov

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