Type 1 Diabetes MellitusNCT00521105
Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
A study testing Virtual visit in people with Type 1 Diabetes Mellitus, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Virtual visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Nov 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Endocrine Clinic, Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
About this study
Official title: Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Virtual visit
- Keywords
- Type 1 Diabetes, Telemedicine, Children
- 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.
Virtual visitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | 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. |
| 2 | Experimental | 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). Receives: Other: Virtual visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA
Measured: 1 year
Secondary outcomes (3)
Resource utilization: physicians, nurses, and dietitians, emergency room visits
Measured: 1 year
Family satisfaction with diabetes care
Measured: 1 year
Associated costs to the family (time away from school and work, travel, etc)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startAug 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Principal investigator, Dr. Danièle Pacaud, University of Calgary
- Investigators
- Danièle Pacaud, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521105
- Sponsor's protocol ID
- AR-2-05-1823-DP
- Status last verified
- Oct 2011
- First submitted
- 24 Aug 2007
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00521105
- Acronym / sponsor ID
- AR-2-05-1823-DP
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes, Telemedicine, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Aug 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –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. |
| 2 | Experimental | Other: Virtual visitParticipants 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). |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual visitParticipants 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. | Other | 2 |
Primary outcome
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA
Time frame: 1 year
3 secondary outcomes
Resource utilization: physicians, nurses, and dietitians, emergency room visits
Time frame: 1 year
Family satisfaction with diabetes care
Time frame: 1 year
Associated costs to the family (time away from school and work, travel, etc)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danièle Pacaud, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual visit in people with Type 1 Diabetes Mellitus, run by University of Calgary 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 3 inclusion and 6 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 6 Oct 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?
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2011.