Diabetes Type 1Phase 2/3NCT02137174

Home and School Visits Intervention for Children With DM TYPE 1

A Phase 2/3 study testing Home and school visits in people with Diabetes Type 1, run by Ben-Gurion University of the Negev at 1 site in Israel.

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

Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus Read more about this study

Who is it for?: Ages 4 to 18 years
Conditions the study is for: Diabetes Type 1
What is being tested?: Home and school visits
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteIsrael
Study dates: Jan 2012to Feb 2014
Phase: Phase 2/3
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

Who may be able to join

HbA1c ≥ 8% at baseline, and diabetes duration of at least 7 months.

Who cannot join

Patients during honeymoon period
Patients and their parents who do not speak Hebrew or Arabic
Patients who were not under any educational system
Patients who had other severe chronic disorders

Trial locations and contacts

1 site in 1 country.

Israel1 site

Pediatric Endocrinology Unit, Soroka Medical Center
Beersheba, 84101

Other trials in Israel

About this study

Official title: The Efficacy of Constructed Intervention by Home and School Visits on Glycemic Control in Children With Type I Diabetes

Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus

Conditions: Diabetes Type 1
Being tested: Home and school visits
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.

Home and school visitsOther
Each child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.

Study groups in NCT02137174
Study group	Role	What they receive
Home and school visits	Active comparator	Not described Receives: Other: Home and school visits
Control	No intervention	Not described

What is being measured

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

HBA1C
Measured: 2 YEARS

Secondary outcomes (3)

Number of DKA episodes
Measured: 2 YEARS
Number of Hospitalizations
Measured: 2 years
Hypoglycemia rate
Measured: 2 years

Timeline

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

Jan 2012Feb 2014

First posted13 May 2014 (estimated)
Study startJan 2012
Primary completionMay 2013
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Type 1Studies 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 2/3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02137174
Sponsor's protocol ID: EH-diab013
Status last verified: May 2014
First submitted: 10 May 2014
Last updated: 13 May 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2014. 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 on Glycemic Control in Children With Type I Diabetes
ClinicalTrials.gov ID: NCT02137174
Acronym / sponsor ID: EH-diab013
Conditions: Diabetes Type 1
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Ben-Gurion University of the NegevUniversity, hospital or other
Study start: Jan 2012
Primary completion: May 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 13 May 2014 (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.

Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Home and school visits	Active comparator	Other: Home and school visits
Control	No intervention	–

Who may qualify

Ages: 4 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

HbA1c ≥ 8% at baseline, and diabetes duration of at least 7 months.

Key exclusion criteria (4 listed)

Patients during honeymoon period
Patients and their parents who do not speak Hebrew or Arabic
Patients who were not under any educational system
Patients who had other severe chronic disorders

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
Home and school visitsEach child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.	Other	Home and school visits

Primary outcome

HBA1C
Time frame: 2 YEARS

3 secondary outcomes

Number of DKA episodes
Time frame: 2 YEARS
Number of Hospitalizations
Time frame: 2 years
Hypoglycemia rate
Time frame: 2 years

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 13 May 2014.

Related trials for Diabetes Type 1

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
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RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Home and school visits in people with Diabetes Type 1, run by Ben-Gurion University of the Negev 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 1 inclusion and 4 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 13 May 2014. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

HBA1C (time frame: 2 YEARS). 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 NCT02137174.

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 13 May 2014.