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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521105
• Other study ID #: AR-2-05-1823-DP
• Status: Completed
• Phase: N/A
• First received: August 24, 2007
• Last updated: October 5, 2011
• Start date: August 2005
• Est. completion date: November 2009

Study information

• Verified date: October 2011
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Virtual visit
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.

Locations

Country	Name	City	State
Canada	Endocrine Clinic, Alberta Children's Hospital	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA		1 year	Yes
Secondary	Resource utilization: physicians, nurses, and dietitians, emergency room visits		1 year	No
Secondary	Family satisfaction with diabetes care		1 year	No
Secondary	Associated costs to the family (time away from school and work, travel, etc)		1 year	No