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MDRS for Prevention of Nocturnal Hypoglycemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01509157
First received: December 25, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: MDRS System (Remote & Safety diabetes management system)
Procedure: Continuous Glucose Monitoring
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Nocturnal Hypoglycemia in Children and Young Adults With Type 1 Diabetes Using a Remote Safety and Control Diabetes Management System

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Reduction in time spent in hypoglycemia [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: Yes ]
  • Parental fear of hypoglycemia [ Time Frame: 4 weeks ( end of study pariod) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Treatment Satisfaction [ Time Frame: between week 0 (baseline) and week 4 (end of study period) ] [ Designated as safety issue: No ]
    We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score

  • Percentage of time spent in the target range [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: No ]
    Percentage of time spent in the target range, defined as sensor glucose level within 63-140 mg/dl

  • Percentage of time spent in the tight normal range [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: No ]
    Percentage of time spent in the tight normal range, defined as sensor glucose level within 80 to 120 mg/dl

  • Average and median of blood glucose levels [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: No ]
  • Percentage of time spent below 63 mg/dl [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: Yes ]
  • Percentage of time spent above 140,180,250 mg/dl [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: No ]
  • Glucose variability [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: No ]
    Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"

  • Hypoglycemic events-number and severity of episodes [ Time Frame: 4 weeks (end of study period) ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDRS system
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)
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
Active Comparator: Continuous Glucose Monitoring
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
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system

  Eligibility

Ages Eligible for Study:   4 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509157

Locations
Israel
Schneider Medical Center
Petah-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01509157     History of Changes
Other Study ID Numbers: rmc006447ctil
Study First Received: December 25, 2011
Last Updated: July 15, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Type 1 diabetes
Continuous Glucose Monitoring
Nocturnal Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014