Skip to main content
OpenTrials
Completed

NCT Number: NCT00521105

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrine Clinic, Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

About this study

Improved metabolic control reduces both the onset and progression of diabetes-related complications in adults and adolescents with type 1 diabetes. Frequency of contact with the medical care team has been associated with better control. Both the American Diabetes Association and Canadian Diabetes Association recommend regular quarterly visits. However, the increase in case loads and the limited manpower available forces us to look at alternative models of care. A model of care in which medical visits alternate between a face to face multidisciplinary visits and a virtual visit done via fax or e-mail communication and a phone call may be advantageous to both the patient and the medical care team. For the patient and his family, this model would decrease time away from school and work, travel inconveniences and costs. For the medical care team it may decrease time per patient and therefore increase the number of patients served with the same resources.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA

    Time frame: 1 year

Secondary outcomes

  1. Resource utilization: physicians, nurses, and dietitians, emergency room visits

    Time frame: 1 year

  2. Family satisfaction with diabetes care

    Time frame: 1 year

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2007
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.