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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521105
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : October 6, 2011
Canadian Diabetes Association
Information provided by (Responsible Party):
Dr. Danièle Pacaud, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Virtual visit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521105

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Canada, Alberta
Endocrine Clinic, Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Canadian Diabetes Association
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Principal Investigator: Danièle Pacaud, MD University of Calgary
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Responsible Party: Dr. Danièle Pacaud, Pediatric Endocrinologist, University of Calgary Identifier: NCT00521105    
Other Study ID Numbers: AR-2-05-1823-DP
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Keywords provided by Dr. Danièle Pacaud, University of Calgary:
Type 1 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases