NCT01401790

Brief Summary

In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient Monitoring Program was developed to allow for:

  • Automatic download of blood glucose levels
  • Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical team
  • Changes in treatment plan by the diabetes professionals
  • E mail exchanges between families and health care professionals
  • Reinforcement of teaching program Use of this program does not replace the existing diabetes education program nor does it preclude contacts with the diabetes team. This service was devised to complement the care already in place for families of children and adolescents with diabetes, hence the term ''telehomecare-enhanced'' approach. Hypotheses
  • This approach would not incur more health problems for Web e Phone users when compared to patients treated by the ''conventional'' approach (telephone and FAX).
  • Use of the Web e Phone would save time for members of the diabetes health providers and consequently cut costs.
  • This means of communication would be acceptable and user friendly for both families and health care professionals. OBJECTIVE - To determine the effects of a telehomecare (THC) program used for 3 months in families of children and adolescents with newly diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS - A bilingual telehomecare program was developed for type 1 diabetes at the Centre Hospitalier Universitaire Sainte-Justine in Montreal. Between February 2008 and August 2009, newly diagnosed patients and their family were randomly assigned to the standard education program or to the telehomecare-enhanced group. Outcomes of interest were patients' and parents' health (reported number for total and nocturnal hypoglycemias; quality of life using the Diabetes Quality of life for Youth questionnaire and a validated Life Habits survey); knowledge of diabetes (using pre and post intervention questionnaires); organizational impacts (number and time for contacts with the nurses or with the physician on call) and family satisfaction with the software application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

July 8, 2011

Last Update Submit

July 22, 2011

Conditions

Diabetes Mellitus, Type 1

Keywords

ChildrenAdolescentsTelehomecare

Outcome Measures

Primary Outcomes (1)

  • Patients' health (reported number of hypoglycemias and nocturnal hypoglycemias)

    All reported hypoglycemias (less than 3 mmol/L) by any means (telephone, FAX or Web e Phone) during the follow up period (3 months) to be accounted for in intervention and control groups

    3 months

Secondary Outcomes (4)

  • Patients and parents' health

    3 months

  • Knowledge of diabetes

    3 months

  • Organizational impacts

    3 months

  • Family satisfaction with the software application

    3 months

Study Arms (2)

Telehomecare

EXPERIMENTAL

3 month use of a new telehomecare program

Device: Telehomecare (Intelligent Distance Patient Monitoring)

Control

ACTIVE COMPARATOR

3 month regular education program and follow up at the Diabetes Clinic

Other: Standard education and follow up at diabetes clinic

Interventions

Telehomecare (Intelligent Distance Patient Monitoring)DEVICE

Randomized patients were to be taugth and to use for 3 months a telehomecare program designed for * Automatic download of blood glucose levels * Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical team * Changes in treatment plan by the diabetes professionals * E mail exchanges between families and health care professionals * Reinforcement of teaching program

Also known as: Telehealth, Telemonitoring
Telehomecare
Standard education and follow up at diabetes clinicOTHER

Patients allocated to the control branch receive standard diabetes teaching and care.

Also known as: Standard diabetes care
Control

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Child or adolescent with newly diagnosed type 1 diabetes

You may not qualify if:

  • Inability to write or communicate in writing in French or English Blindness Exclusive follow up in another health center once teaching is complete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (6)

  • Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.

    PMID: 12716807BACKGROUND

  • d'Annunzio G, Bellazzi R, Larizza C, Montani S, Pennati C, Castelnovi C, Stefanelli M, Rondini G, Lorini R. Telemedicine in the management of young patients with type 1 diabetes mellitus: a follow-up study. Acta Biomed. 2003;74 Suppl 1:49-55.

    PMID: 12817805BACKGROUND

  • Izquierdo R, Morin PC, Bratt K, Moreau Z, Meyer S, Ploutz-Snyder R, Wade M, Weinstock RS. School-centered telemedicine for children with type 1 diabetes mellitus. J Pediatr. 2009 Sep;155(3):374-9. doi: 10.1016/j.jpeds.2009.03.014. Epub 2009 May 21.

    PMID: 19464030BACKGROUND

  • Pare G, Jaana M, Sicotte C. Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc. 2007 May-Jun;14(3):269-77. doi: 10.1197/jamia.M2270. Epub 2007 Feb 28.

    PMID: 17329725BACKGROUND

  • Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 2006 Oct;165(10):701-5. doi: 10.1007/s00431-006-0156-6. Epub 2006 May 3.

    PMID: 16670859BACKGROUND

  • Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.

    PMID: 16525844BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 25, 2011

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

CA(1)