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

NCT00542334 | Completed

• 1 other identifier: 07/02S(E)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency and magnitude of nocturnal hypoglycemia

  3 days

Secondary Outcomes (1)

• Patient satisfaction with continuous glucose sensing

  3 days

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with type 1 diabetes

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Children's Hosiptal of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• 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.

  PMID: 21414634 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alexandra H Ahmet, MD, BSc,FRCPC

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- MD,BSc, FRCPC

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

CA (1)