NCT01509157

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

December 25, 2011

Last Update Submit

July 15, 2013

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesContinuous Glucose MonitoringNocturnal Hypoglycemia

Outcome Measures

Primary Outcomes (2)

  • Reduction in time spent in hypoglycemia

    4 weeks (end of study period)

  • Parental fear of hypoglycemia

    4 weeks ( end of study pariod)

Secondary Outcomes (8)

  • Change in Treatment Satisfaction

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

  • Percentage of time spent in the target range

    4 weeks (end of study period)

  • Percentage of time spent in the tight normal range

    4 weeks (end of study period)

  • Average and median of blood glucose levels

    4 weeks (end of study period)

  • Percentage of time spent below 63 mg/dl

    4 weeks (end of study period)

  • +3 more secondary outcomes

Study Arms (2)

MDRS system

EXPERIMENTAL

Participants 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

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

Continuous Glucose Monitoring

ACTIVE COMPARATOR

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

Procedure: Continuous Glucose Monitoring

Interventions

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

MDRS system
Continuous Glucose MonitoringPROCEDURE

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

Continuous Glucose Monitoring

Eligibility Criteria

Age4 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Medical Center

Petah Tikva, 49202, Israel

Location

Related Publications (1)

  • 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.

    PMID: 25211216DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Moshe Phillip, Prof

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2011

First Posted

January 12, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

IL(1)