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

NCT ID: NCT00542334

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-06-30

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.

Conditions

Nocturnal Hypoglycemia; Type 1 Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Ahmet

Principal Investigator- MD,BSc, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra H Ahmet, MD, BSc,FRCPC

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Children's Hosiptal of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

References

Ahmet A, Dagenais S, Barrowman NJ, Collins CJ, Lawson ML. Prevalence of nocturnal hypoglycemia in pediatric type 1 diabetes: a pilot study using continuous glucose monitoring. J Pediatr. 2011 Aug;159(2):297-302.e1. doi: 10.1016/j.jpeds.2011.01.064. Epub 2011 Mar 17.

Reference Type: DERIVED

PMID: 21414634 (View on PubMed)

Other Identifiers

07/02S(E)

Identifier Type: -

Identifier Source: org_study_id