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Type 1 DiabetesPhase 1MDRSNCT01509157

MDRS for Prevention of Nocturnal Hypoglycemia

A Phase 1 study testing MDRS System (Remote & Safety diabetes management system) and Continuous Glucose Monitoring in people with Type 1 Diabetes, run by Rabin Medical Center 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

The investigators have developed a unique Remote \& Safety diabetes management system (MDRS) that offers real-time remote monitoring and control of glucose levels. The system allows the supervising personal to alarm the patient and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or… Read more about this study

Who is it for?
Ages 4 to 24 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
MDRS System (Remote & Safety diabetes management system) and Continuous Glucose Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteIsrael
Study dates
Jan 2012to Apr 2013
Phase
Phase 1
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 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Type 1 diabetes diagnosed at least 1 year prior to study entry
  • Continuous subcutaneous insulin infusion pump for at least 3 month prior to study entry
  • Use of continuous glucose measurement device for at least one month prior to study entry
  • Age: 4-24 years old
  • HbA1c < =8.5%
  • No more than one severe hypoglycemia or an episode diabetic ketoacidosis within the year prior to study entry, and none within the month prior to study entry.
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  • Capable of reading a pump screen in English
  • Capable of operating the MDRS software
  • A patient older than 18 years- leaving routinely with at least one more adult(age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
  • A patient younger than 18 years- leaving routinely with at least two adults (age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
  • All participants must provide an adult independent contact person, leaving near by the participant, capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal. This person will be called into action in emergency cases in which the participant or his household members can not be reached.
  • Capable of completing the hypoglycemia the relevant surveys
  • Able to understand and sign an informed consent forms

Who cannot join

  • Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
  • Patients participating in other device or drug studies
  • Known dermal hypersensitivity to trial products or those that contain medical adhesive
  • Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication for participation in the study.
  • Inability to understand/complete the hypoglycemia fear survey
  • Female subject who is pregnant or planning to become pregnant within the planned study duration

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Schneider Medical Center

    Petah Tikva, 49202

Other trials in Israel

About this study

Official title: Prevention of Nocturnal Hypoglycemia in Children and Young Adults With Type 1 Diabetes Using a Remote Safety and Control Diabetes Management System

The investigators have developed a unique Remote \& Safety diabetes management system (MDRS) that offers real-time remote monitoring and control of glucose levels. The system allows the supervising personal to alarm the patient and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults.The aim of this feasibility study is to evaluate the efficacy of the MDRS system in preventing nocturnal hypoglycemia in children and young adults with type 1 diabetes.

Conditions
Type 1 Diabetes
Being tested
MDRS System (Remote & Safety diabetes management system), Continuous Glucose Monitoring
Keywords
Type 1 diabetes, Continuous Glucose Monitoring, Nocturnal Hypoglycemia
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.

  • MDRS System (Remote & Safety diabetes management system)Device

    Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults

  • Continuous Glucose MonitoringProcedure or surgery

    Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system

Study groups in NCT01509157
Study groupRoleWhat they receive
MDRS systemExperimentalParticipants will be using the MDRS system combined with their regular treatment with Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
Receives: Device: MDRS System (Remote & Safety diabetes management system)
Continuous Glucose MonitoringActive comparatorParticipants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Receives: Procedure: Continuous Glucose Monitoring

What is being measured

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

  1. Reduction in time spent in hypoglycemia

    Measured: 4 weeks (end of study period)

  2. Parental fear of hypoglycemia

    Measured: 4 weeks ( end of study pariod)

Secondary outcomes (8)

  1. Change in Treatment Satisfaction

    We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score

    Measured: between week 0 (baseline) and week 4 (end of study period)

  2. Percentage of time spent in the target range

    Percentage of time spent in the target range, defined as sensor glucose level within 63-140 mg/dl

    Measured: 4 weeks (end of study period)

  3. Percentage of time spent in the tight normal range

    Percentage of time spent in the tight normal range, defined as sensor glucose level within 80 to 120 mg/dl

    Measured: 4 weeks (end of study period)

  4. Average and median of blood glucose levels

    Measured: 4 weeks (end of study period)

  5. Percentage of time spent below 63 mg/dl

    Measured: 4 weeks (end of study period)

  6. Percentage of time spent above 140,180,250 mg/dl

    Measured: 4 weeks (end of study period)

  7. Glucose variability

    Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"

    Measured: 4 weeks (end of study period)

  8. Hypoglycemic events-number and severity of episodes

    Measured: 4 weeks (end of study period)

Timeline

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

  1. First posted12 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2013
  4. Study completionApr 2013

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01509157
Sponsor's protocol ID
rmc006447ctil
Acronym
MDRS
Status last verified
Jul 2013
First submitted
25 Dec 2011
Last updated
16 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Oron T, Farfel A, Muller I, Miller S, Atlas E, Nimri R, Phillip M. A remote monitoring system for artificial pancreas support is safe, reliable, and user friendly. Diabetes Technol Ther. 2014 Nov;16(11):699-705. doi: 10.1089/dia.2014.0090. Epub 2014 Sep 11.

    PubMed 25211216

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDRS System (Remote & Safety diabetes management system) and Continuous Glucose Monitoring in people with Type 1 Diabetes, run by Rabin 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 13 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 16 Jul 2013. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Reduction in time spent in hypoglycemia (time frame: 4 weeks (end of study period)). The study lists 2 primary outcomes in all. 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 NCT01509157, 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 16 Jul 2013.

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