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MDRS for Prevention of Nocturnal Hypoglycemia (MDRS)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
MDRS System (Remote & Safety diabetes management system)
Continuous Glucose Monitoring
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Continuous Glucose Monitoring, Nocturnal Hypoglycemia

Eligibility Criteria

4 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schneider Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MDRS system

Continuous Glucose Monitoring

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction in time spent in hypoglycemia
Parental fear of hypoglycemia

Secondary Outcome Measures

Change in Treatment Satisfaction
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
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
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
Percentage of time spent below 63 mg/dl
Percentage of time spent above 140,180,250 mg/dl
Glucose variability
Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"
Hypoglycemic events-number and severity of episodes

Full Information

First Posted
December 25, 2011
Last Updated
July 15, 2013
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01509157
Brief Title
MDRS for Prevention of Nocturnal Hypoglycemia
Acronym
MDRS
Official Title
Prevention of Nocturnal Hypoglycemia in Children and Young Adults With Type 1 Diabetes Using a Remote Safety and Control Diabetes Management System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Continuous Glucose Monitoring, Nocturnal Hypoglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDRS system
Arm Type
Experimental
Arm Description
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
Arm Title
Continuous Glucose Monitoring
Arm Type
Active Comparator
Arm Description
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Intervention Type
Device
Intervention Name(s)
MDRS System (Remote & Safety diabetes management system)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Primary Outcome Measure Information:
Title
Reduction in time spent in hypoglycemia
Time Frame
4 weeks (end of study period)
Title
Parental fear of hypoglycemia
Time Frame
4 weeks ( end of study pariod)
Secondary Outcome Measure Information:
Title
Change in Treatment Satisfaction
Description
We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score
Time Frame
between week 0 (baseline) and week 4 (end of study period)
Title
Percentage of time spent in the target range
Description
Percentage of time spent in the target range, defined as sensor glucose level within 63-140 mg/dl
Time Frame
4 weeks (end of study period)
Title
Percentage of time spent in the tight normal range
Description
Percentage of time spent in the tight normal range, defined as sensor glucose level within 80 to 120 mg/dl
Time Frame
4 weeks (end of study period)
Title
Average and median of blood glucose levels
Time Frame
4 weeks (end of study period)
Title
Percentage of time spent below 63 mg/dl
Time Frame
4 weeks (end of study period)
Title
Percentage of time spent above 140,180,250 mg/dl
Time Frame
4 weeks (end of study period)
Title
Glucose variability
Description
Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"
Time Frame
4 weeks (end of study period)
Title
Hypoglycemic events-number and severity of episodes
Time Frame
4 weeks (end of study period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Medical Center
City
Petah-Tikva
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
25211216
Citation
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.
Results Reference
derived

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MDRS for Prevention of Nocturnal Hypoglycemia

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