NCT00475345

Brief Summary

The purpose of this study is to determine whether or not bedtime snacks are necessary to prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1 diabetes who are using intensive insulin therapies, either multiple injections of insulin or insulin pump. We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well adjusted and delivered, especially by use of insulin pump which is considered the "gold standard" for overnight blood glucose control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

May 16, 2007

Last Update Submit

May 17, 2007

Conditions

Type 1 Diabetes Mellitus

Keywords

Nocturnal hypoglycemiaBedtime snacksContinuous glucose monitoringContinuous subcutaneous insulin infusionCSIIIntensive therapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of nocturnal hypoglycemia (< 4mmol/L) occurring between 11pm and 7am, as determined with the Continuous Glucose Monitoring System (CGMS) and hemoglobin A1c

    end of 3 months for each group

Secondary Outcomes (1)

  • Nadir nocturnal BG, timing and duration of nocturnal hypoglycemia, fasting BG, lipid profile, psychosocial factors, total insulin dose, insulin sensitivity and body composition (weight, BMI, % fat, waist circumference).

    end of 3 months for each group

Interventions

Bedtime snacksBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with type 1 diabetes for more than 3 years duration and on intensive insulin therapy using multiple daily injections of insulin (MDI) for at least 1 year prior to study.

You may not qualify if:

  • Pregnant women or intending to become pregnant in next year,
  • Significant hepatic or renal disease,
  • Active cancer,
  • Abuse of alcohol or drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A-1A1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jean_Francois Yale, MD

    McGill Nutrition and Food Science Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 21, 2007

Study Start

August 1, 2000

Study Completion

September 1, 2001

Last Updated

May 21, 2007

Record last verified: 2007-05

Locations

CA(1)