MDRS for Prevention of Nocturnal Hypoglycemia (MDRS)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: MDRS System (Remote & Safety diabetes management system); Procedure: Continuous Glucose Monitoring

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel, 49202
    • Schneider Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in time spent in hypoglycemia	4 weeks (end of study period)
Parental fear of hypoglycemia	4 weeks ( end of study pariod)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Treatment Satisfaction	We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score	between week 0 (baseline) and week 4 (end of study period)
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	4 weeks (end of study period)
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	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)
Percentage of time spent above 140,180,250 mg/dl		4 weeks (end of study period)
Glucose variability	Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"	4 weeks (end of study period)
Hypoglycemic events-number and severity of episodes		4 weeks (end of study period)

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 25, 2011
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 15, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Type 1 diabetes; Nocturnal Hypoglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: rmc006447ctil