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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014