Clinical trial NCT00521105: Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
Official title: Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes
Telemedicine
Children
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2007-08-27
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA
timeFrame: 1 year
Secondary outcomes:
measure: Resource utilization: physicians, nurses, and dietitians, emergency room visits
timeFrame: 1 year
measure: Family satisfaction with diabetes care
timeFrame: 1 year
measure: Associated costs to the family (time away from school and work, travel, etc)
timeFrame: 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Endocrine Clinic, Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Danièle Pacaud, MD
role: PRINCIPAL_INVESTIGATOR
References: