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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542334
• Other study ID #: 07/02S(E)
• Status: Completed
• Start date: September 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2018
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Nocturnal Hypoglycemia
• Type 1 Diabetes

Locations

Country	Name	City	State
Canada	Children's Hosiptal of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and magnitude of nocturnal hypoglycemia		3 days
Secondary	Patient satisfaction with continuous glucose sensing		3 days