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
  Purpose

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


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target

Resource links provided by NLM:


Further study details as provided by Diabetes Care Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from the Diabetes Care Center clinic

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548222

Locations
United States, California
Diabetes Care Center
Salinas, California, United States, 93901
Sponsors and Collaborators
Diabetes Care Center
Medtronic
  More Information

Publications:
Responsible Party: Diabetes Care Center
ClinicalTrials.gov Identifier: NCT01548222     History of Changes
Other Study ID Numbers: MM2012
Study First Received: February 27, 2012
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Diabetes Care Center:
type 2 diabetes
continuous glucose
basal insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014