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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00542334

Enrollment

Registered

2007-10-11

Start date

2008-09-30

Completion date

2009-06-30

Last updated

2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal Hypoglycemia, Type 1 Diabetes

Keywords

Nocturnal Hypoglycemia, Type 1 diabetes, Children, Adolescents, CGMS

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency and magnitude of nocturnal hypoglycemia	3 days

Secondary

Measure	Time frame
Patient satisfaction with continuous glucose sensing	3 days

Countries

Canada

Outcome results