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OpenTrials
Completed

NCT Number: NCT01548222

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

This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Care Center

Salinas, California, 93901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of time CGM glucose is <70mg/dl

    Time frame: the subject will be followed for 9 days

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

Secondary outcomes

  1. Percentage of time CGM glucose is <40 mg/dl

    Time frame: the subject will be followed for 9 days

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

  2. Determined hypoglycaemic episodes

    Time frame: the subject will be followed for 9 days

    The percentage of subjects who perceived all CGM determined hypoglycaemic episodes

  3. Weight gain

    Time frame: the subject will be followed for 9 days

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

Sponsors and collaborators

Lead sponsor

Diabetes Care Center

Industry

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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