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

This study has been completed.
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Dr. Danièle Pacaud, University of Calgary
ClinicalTrials.gov Identifier:
NCT00521105
First received: August 24, 2007
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
 Other: Virtual visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Resource utilization: physicians, nurses, and dietitians, emergency room visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Family satisfaction with diabetes care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Associated costs to the family (time away from school and work, travel, etc) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: August 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
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.
Experimental: 2
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
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.

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

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521105

Locations
Canada, Alberta
Endocrine Clinic, Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Canadian Diabetes Association
Investigators
Principal Investigator: Danièle Pacaud, MD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. Danièle Pacaud, Pediatric Endocrinologist, University of Calgary
ClinicalTrials.gov Identifier: NCT00521105     History of Changes
Other Study ID Numbers: AR-2-05-1823-DP
Study First Received: August 24, 2007
Last Updated: October 5, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Type 1 Diabetes
Telemedicine
Children

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013