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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Diabetes Care Center
ClinicalTrials.gov Identifier:
NCT01548222
First received: February 27, 2012
Last updated: August 23, 2013
Last verified: August 2013

February 27, 2012
August 23, 2013
February 2012
December 2012   (final data collection date for primary outcome measure)
Percentage of time CGM glucose is <70mg/dl [ Time Frame: the subject will be followed for 9 days ] [ Designated as safety issue: No ]
The percentage of time CGM glucose is <70 mg/dl during the basal glucose evaluation
Same as current
Complete list of historical versions of study NCT01548222 on ClinicalTrials.gov Archive Site
  • Percentage of time CGM glucose is <40 mg/dl [ Time Frame: the subject will be followed for 9 days ] [ Designated as safety issue: No ]
    The percentage of time the CGM glucose is <40 mg/dl
  • Determined hypoglycaemic episodes [ Time Frame: the subject will be followed for 9 days ] [ Designated as safety issue: No ]
    The percentage of subjects who perceived all CGM determined hypoglycaemic episodes
  • Weight gain [ Time Frame: the subject will be followed for 9 days ] [ Designated as safety issue: No ]
    The mean weight gain since initiating basal insulin fromo retrospectively gathered data.
Same as current
Not Provided
Not Provided
 
CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects will be recruited from the Diabetes Care Center clinic

Type 2 Diabetes
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01548222
MM2012
No
Diabetes Care Center
Diabetes Care Center
Medtronic
Not Provided
Diabetes Care Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP