Timing of Insulin Before Meals Everyday (TIME)

This study has been completed.

Sponsor:

Collaborator:

American Diabetes Association

Information provided by (Responsible Party):

David S. Schade, University of New Mexico

ClinicalTrials.gov Identifier:

NCT00789945

First received: November 11, 2008

Last updated: April 4, 2013

Last verified: April 2013

History of Changes

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 Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	The Importance of Insulin Timing in Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

To determine the changes in A1C. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine changes in postprandial glucose excursion during the meal's 5 hour postprandial period. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

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.

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	David S. Schade, MD, University of New Mexico
ClinicalTrials.gov Identifier:	NCT00789945 History of Changes
Other Study ID Numbers:	08-147
Study First Received:	November 11, 2008
Last Updated:	April 4, 2013
Health Authority:	United States: Federal Government

Keywords provided by University of New Mexico:

type 1 diabetes
continuous glucose monitoring
Intensive Insulin therapy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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