Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS)

Prevalence of Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes on a Standard (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS) - A Pilot Study

Sponsors

Lead Sponsor: Children's Hospital of Eastern Ontario

Collaborator: The Physicians' Services Incorporated Foundation

Source Children's Hospital of Eastern Ontario
Brief Summary

This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low blood sugar at night during sleep), in children with type 1 diabetes who are on a standard insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH) can be associated with significant morbidity including seizure and coma. The investigators intend to use the CGMS in a future study investigating the use of a new insulin combination aimed to decrease the frequency of NH in the pediatric population.

Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a CGMS for 3 days. During this time the participants will be required to test and record self-monitored blood glucose readings at designated time periods and if they have symptoms of hypoglycemia. The comparison of these values with each other and with different previously defined values of NH will allow for a clear definition of NH to be made. A survey has also been designed to assess participant satisfaction with the CGMS.

Overall Status Completed
Start Date September 2008
Completion Date June 2009
Primary Completion Date June 2009
Study Type Observational
Primary Outcome
Measure Time Frame
Frequency and magnitude of nocturnal hypoglycemia 3 days
Secondary Outcome
Measure Time Frame
Patient satisfaction with continuous glucose sensing 3 days
Enrollment 30
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Type 1 diabetes

- less than 18 years of age

- >2 year duration of diabetes

- on a conventional TID insulin regimen (morning and bedtime NPH) for a minimum of 3 months

- informed consent and assent

Exclusion Criteria:

- medical conditions other than treated hypothyroidism or asthma requiring oral glucocorticoids more than once per year

- intention to move outside of CHEO's catchment area within the next 4 months

- more than 17 years of age and unwilling to continue receiving diabetes care at CHEO until study completion

- intention to switch to a different insulin regimen prior to study completion

Gender: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Alexandra H Ahmet, MD, BSc,FRCPC Principal Investigator Children's Hospital of Eastern Ontario
Location
Facility: Children's Hosiptal of Eastern Ontario
Location Countries

Canada

Verification Date

July 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Children's Hospital of Eastern Ontario

Investigator Full Name: Alexandra Ahmet

Investigator Title: Principal Investigator- MD,BSc, FRCPC

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Case-Only

Time Perspective: Cross-Sectional

Source: ClinicalTrials.gov