Type 1 DiabetesNCT00566475
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
A study testing telemedicine in people with Type 1 Diabetes, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2008
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
- Grade K-8
- Age 5-14 at time of enrollment
- Consent of student, parent and school
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
The purpose of this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.
Read the detailed description
Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling.
- Conditions
- Type 1 Diabetes
- Being tested
- telemedicine
- 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.
telemedicineOther
School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual care of type 1 diabetes at the diabetes center |
| 2 | Experimental | Usual care at the diabetes center supplemented by a telemedicine intervention in the school involving school personnel, the child with diabetes and at least 1 parent of the child. The diabetes center NP conducts videovisits with the school nurse, patient (child) +/- parent monthly. Receives: Other: telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c
Measured: 1 year
Secondary outcomes (1)
glucose levels, hypoglycemia, quality of life, satisfaction
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 posted3 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, New York State Department of Health, Children's Miracle Network
- Responsible party
- Principal investigator, Roberto Izquierdo, State University of New York - Upstate Medical University
- Investigators
- Ruth S Weinstock, MD PhD, Principal investigator, State University of New York - Upstate Medical UniversityRoberto E Izquierdo, MD, Study director, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566475
- Sponsor's protocol ID
- IRB#5302
- Status last verified
- Oct 2017
- First submitted
- 29 Nov 2007
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00566475
- Acronym / sponsor ID
- IRB#5302
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, New York State Department of Health, Children's Miracle Network
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Dec 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 this study is to determine if using school-based telemedicine for diabetes support and education in students with type 1 diabetes in grades K-8 can lead to improvement in control of diabetes and improved satisfaction of all caregivers.
Detailed description
Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual care of type 1 diabetes at the diabetes center |
| 2 | Experimental | Other: telemedicineUsual care at the diabetes center supplemented by a telemedicine intervention in the school involving school personnel, the child with diabetes and at least 1 parent of the child. The diabetes center NP conducts videovisits with the school nurse, patient (child) +/- parent monthly. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 1 diabetes under care of Joslin Diabetes Center in Syracuse NY
- Grade K-8
- Age 5-14 at time of enrollment
- Consent of student, parent and school
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| telemedicineSchool telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent | Other | 2 |
Primary outcome
hemoglobin A1c
Time frame: 1 year
1 secondary outcome
glucose levels, hypoglycemia, quality of life, satisfaction
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 14 Oct 2021.
- Results publication: PubMed 19464030Izquierdo 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.
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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.
Ruth S Weinstock, MD PhD principal investigator
State University of New York - Upstate Medical University
Roberto E Izquierdo, MD study director
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telemedicine in people with Type 1 Diabetes, run by State University of New York - Upstate Medical University at 1 site in United States.
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 4 inclusion and 0 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 14 Oct 2021. 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 United States. 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?
hemoglobin A1c (time frame: 1 year). 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 NCT00566475, which also lists 1 linked publication.
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 14 Oct 2021; AzTrials last refreshed its copy on 3 Nov 2026.