NCT00340613

Brief Summary

We hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control, grades, and decreases school absences in children and teens with poorly controlled T1DM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

First QC Date

June 19, 2006

Last Update Submit

July 12, 2016

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesPoorly controlled glucoseadolescents

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    At the start of the study and again in 3 months

Secondary Outcomes (1)

  • Urine microalbumin

    At the beginning and the end of the study

Interventions

glargine insulinDRUG

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Child with T1DM for at least 1 year
  • Age 10-19 years
  • Have a Hgb A1C greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months.
  • School must have a school nurse

You may not qualify if:

  • Child who has Type 2 diabetes
  • Subject receiving home schooling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Diabetes Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Nguyen TM, Mason KJ, Sanders CG, Yazdani P, Heptulla RA. Targeting blood glucose management in school improves glycemic control in children with poorly controlled type 1 diabetes mellitus. J Pediatr. 2008 Oct;153(4):575-8. doi: 10.1016/j.jpeds.2008.04.066.

    PMID: 18847622DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Rubina A Heptulla, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2007

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

US(1)