Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes

NCT00521105 | Completed

• 1 other identifier: AR-2-05-1823-DP
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to look at the effect of replacing the physician only visit by a transmission of information on the participant's current diabetes management and blood glucose monitoring results followed by a phone contact by the diabetes nurse educator. The study will also measure the effect on diabetes control (HbA1c), satisfaction with care, resource utilisation, and costs to the health care system and to the participant. We hypothesize that replacement of the physician-only visit by a virtual visit will not result in worsening of the medical outcomes and that it will result in a reduction in medical resources utilization and costs for families while increasing the satisfaction with care.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes; Telemedicine; Children

Outcome Measures

Primary Outcomes (1)

• Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA

  1 year

Secondary Outcomes (3)

• Resource utilization: physicians, nurses, and dietitians, emergency room visits

  1 year

• Family satisfaction with diabetes care

  1 year

• Associated costs to the family (time away from school and work, travel, etc)

  1 year

Study Arms (2)

1

NO INTERVENTION

Participants will be seen every 3-4 months with a physician-only visit alternating with a multidisciplinary visit (MD, RN and RD). This is the current standard of practice.

2

EXPERIMENTAL

Participants will be seen every 3-4 months with a phone contact, with the diabetes nurse educator, alternating with a multidisciplinary visit (MD, RN and RD).

Other: Virtual visit

Interventions

Virtual visit OTHER

Participants will alternate between a multidisciplinary visit (MD, RN and RD) and a phone contact with the diabetes nurse educator (the phone contact will replace the physician-only visit). Prior to the phone contact, transmission of information from the participant will be sent through either fax or a web browser.

2

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children: 17 years of age or less
• Diagnosis of Type 1 Diabetes for at least 12 months
• Currently being followed at the Alberta Children's Hospital Diabetes Clinic.

You may not qualify if:

• Compromised metabolic control (HbA1c \> 10%)
• Uncontrolled hypo or hyperthyroidism
• Uncontrolled celiac disease
• Language or psychosocial barrier preventing the family from completing the study
• Diabetes duration of less than 1 year
• Participation in other clinical trials with specified clinic visits.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Diabetes Association: collaborator

Study Sites (1)

Endocrine Clinic, Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

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

• Danièle Pacaud, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: August 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

CA (1)