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Timing of Insulin Before Meals Everyday (TIME)

This study has been completed.
American Diabetes Association
Information provided by (Responsible Party):
David S. Schade, University of New Mexico Identifier:
First received: November 11, 2008
Last updated: April 4, 2013
Last verified: April 2013
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


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

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
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 identifier: NCT00789945

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
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 Identifier: NCT00789945     History of Changes
Other Study ID Numbers: 08-147
Study First Received: November 11, 2008
Last Updated: April 4, 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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017