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Diabetes Mellitus, Type 1NCT01401790

Use of a Telehomecare Program for Young Patients With New Onset Type 1 Diabetes

A study testing Telehomecare (Intelligent Distance Patient Monitoring) and Standard education and follow up at diabetes clinic in people with Diabetes Mellitus, Type 1, run by Huot, Celine, M.D. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Telehomecare (Intelligent Distance Patient Monitoring) and Standard education and follow up at diabetes clinic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteCanada
Study dates
Feb 2008to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Child or adolescent with newly diagnosed type 1 diabetes

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

Other trials in Canada

About this study

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
Read more

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.

Read the detailed description

STUDY PROTOCOL

This is a randomized controlled study, unblinded.

The recruitment occured on Day 3 of teaching: random assignment (1:1) to receive either traditional follow up (telephone contacts and FAX communications) with the designated nurse OR a follow up with telehomecare PLUS the follow up by a specialized nurse.

If the patient is designated to telehomecare, the training is provided on day of recruitment and patient leaves with the Web e Phone. Activation of the device must be done at home to enable for transmission of information.

Families complete questionnaires to evaluate knowledge, Quality of Life Questionnaires (Skinner modified), a validated Life Habits survey and a satisfaction questionnaire at recruitment (time 0) and at study completion (3 months) (Children must be aged more than 8 years).

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

Being tested
Telehomecare (Intelligent Distance Patient Monitoring), Standard education and follow up at diabetes clinic
Keywords
Children, Adolescents, Telehomecare
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehomecare (Intelligent Distance Patient Monitoring)Device

    Also called Telehealth, Telemonitoring

    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

  • Standard education and follow up at diabetes clinicOther

    Also called Standard diabetes care

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

Study groups in NCT01401790
Study groupRoleWhat they receive
TelehomecareExperimental3 month use of a new telehomecare program
Receives: Device: Telehomecare (Intelligent Distance Patient Monitoring)
ControlActive comparator3 month regular education program and follow up at the Diabetes Clinic
Receives: Other: Standard education and follow up at diabetes clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (4)

  1. Patients and parents' health

    Families complete questionnaires to evaluate Quality of Life Questionnaires (Skinner modified) and a validated Life Habits Questionnaire at recruitment and at study completion (Children must be more than 8 years).

    Measured: 3 months

  2. Knowledge of diabetes

    using in house validated pre and post intervention questionnaires

    Measured: 3 months

  3. Organizational impacts

    Number and time required for contacts with the nurse at the clinic and / or with the physician on call

    Measured: 3 months

  4. Family satisfaction with the software application

    Using an in house validated questionnaire

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2011 (estimated)
  2. Study startFeb 2008
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01401790
Sponsor's protocol ID
CHUSTEJUSTINE2644
Status last verified
Jul 2011
First submitted
8 Jul 2011
Last updated
25 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12716807

  • 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.

    PubMed 12817805

  • 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.

    PubMed 19464030

  • 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.

    PubMed 17329725

  • 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.

    PubMed 16670859

  • 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.

    PubMed 16525844

Questions about this trial

What is this clinical trial studying?

A study testing Telehomecare (Intelligent Distance Patient Monitoring) and Standard education and follow up at diabetes clinic in people with Diabetes Mellitus, Type 1, run by Huot, Celine, M.D. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' health (reported number of hypoglycemias and nocturnal hypoglycemias) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01401790, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.

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