Type 1 Diabetes MellitusNCT01382459
Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to not given
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka.
Who may be able to join
- Type 1 DM diagnosis from at least 8 months/
- HbA1C levels >8
- Signed inform consent.
Who cannot join
- Children who are not in educational settings and are not hebrew or arabic speakers.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Soroka medical center
Beersheba, Israel
Eli Hershkovitz, PI, 972-522629025, elih@bgu.ac.il
About this study
Official title: The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes
The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.
Read the detailed description
The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:
- A decrease in HbA1C levels.
- A decrease in Hypoglycemia events.
- A decrease in DKA events.
- A decrease in patients' visits in ER and hospitalizations.
- An improvement in the knowledge of the patients and their families about the disease.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- 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.
| Study group | Role | What they receive |
|---|---|---|
| type 1 DM children- intervention group | will have home visits and trainings at school | |
| type 1 DM children- control group | will receive the standard care at the clinic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382459
- Sponsor's protocol ID
- sor517111ctil
- Status last verified
- Jun 2011
- First submitted
- 23 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes
- ClinicalTrials.gov ID
- NCT01382459
- Acronym / sponsor ID
- sor517111ctil
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Jul 2011
- First posted
- 27 Jun 2011 (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 investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.
Detailed description
The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:
- A decrease in HbA1C levels.
- A decrease in Hypoglycemia events.
- A decrease in DKA events.
- A decrease in patients' visits in ER and hospitalizations.
- An improvement in the knowledge of the patients and their families about the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 1 DM children- intervention group | – | –will have home visits and trainings at school |
| type 1 DM children- control group | – | –will receive the standard care at the clinic |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka.
Key inclusion criteria (3 listed)
- Type 1 DM diagnosis from at least 8 months/
- HbA1C levels >8
- Signed inform consent.
Key exclusion criteria (1 listed)
- Children who are not in educational settings and are not hebrew or arabic speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Soroka University Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 27 Jun 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eli Hershkovitz, PI (972- 522629025, elih@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Jun 2011.