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Timing of Insulin Before Meals Everyday (TIME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789945
First Posted: November 13, 2008
Last Update Posted: April 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
David S. Schade, University of New Mexico
  Purpose
The inclusion of "Timing of premeal insulin administration (Timing)" in an Intensive Insulin Therapy regimen will reduce A1C by an average of 1% in type 1 diabetic patients who have initial A1C's between 7.0% and 9.0%.

Condition Intervention
Type 1 Diabetes Other: Control Other: Study Arm B

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Importance of Insulin Timing in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by David S. Schade, University of New Mexico:

Primary Outcome Measures:
  • To determine the changes in A1C. [ Time Frame: 8 months ]

Secondary Outcome Measures:
  • To determine changes in postprandial glucose excursion during the meal's 5 hour postprandial period. [ Time Frame: 8 months ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Study Arm A
Study Arm A will be the primary control arm.
Other: Control
Study Arm A will consist of patients with Type 1 diabetes who will continue their current intensive insulin therapy regimen with no additional interventions by the investigators. Their primary care providers will continue to manage their diabetes to obtain the best control as possible of their glucose, lipids, and blood pressure. Continuous Glucose Monitoring will be monitored. No timing of premeal insulin administration will be utilized in this arm.
Other Name: Control group- No "timing" insulin administartion.
Experimental: Study Arm B
Study Arm B will serve as the intervention arm.
Other: Study Arm B
Study Arm B will include participants with type 1 diabetes which will utilize "Timing" to adjust their pre-meal insulin dosages. Participants will continue taking their current insulin and will be placed on a continuous glucose monitor.
Other Name: Intervention- "Timing" of insulin administration.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 diabetic participants, History of insulin dependance for at least one year, A1C 7%-9%, normal CBC, Chemistry Profile,be sufficiently stable.

Exclusion Criteria:

  • pregnant women, children, prisoners, mentally ill individuals, patients currently utilizing continuous glucose monitors.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789945


Locations
United States, New Mexico
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
American Diabetes Association
Investigators
Principal Investigator: David S Schade, MD University of New Mexico, Health Sciences Center
  More Information

Responsible Party: David S. Schade, MD, University of New Mexico
ClinicalTrials.gov Identifier: NCT00789945     History of Changes
Other Study ID Numbers: 08-147
First Submitted: November 11, 2008
First Posted: November 13, 2008
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by David S. Schade, University of New Mexico:
type 1 diabetes
continuous glucose monitoring
Intensive Insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs