Timing of Insulin Before Meals Everyday

NCT00789945 | Terminated DMC

• 1 other identifier: 08-147
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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%.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; continuous glucose monitoring; Intensive Insulin therapy

Outcome Measures

Primary Outcomes (1)

• To determine the changes in A1C.

  8 months

Secondary Outcomes (1)

• To determine changes in postprandial glucose excursion during the meal's 5 hour postprandial period.

  8 months

Study Arms (2)

Study Arm A

PLACEBO COMPARATOR

Study Arm A will be the primary control arm.

Other: Control

Study Arm B

EXPERIMENTAL

Study Arm B will serve as the intervention arm.

Other: Study Arm B

Interventions

Control OTHER

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.

Also known as: Control group- No "timing" insulin administartion.

Study Arm A

Study Arm B OTHER

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.

Also known as: Intervention- "Timing" of insulin administration.

Study Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant women, children, prisoners, mentally ill individuals, patients currently utilizing continuous glucose monitors.

Sponsors & Collaborators

• University of New Mexico: lead
• American Diabetes Association: collaborator

Study Sites (2)

UNM HSC Diabetes Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Unm Hsc Gcrc

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David S Schade, MD

  University of New Mexico, Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (2)