MDRS for Prevention of Nocturnal Hypoglycemia

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509157
• Other study ID #: rmc006447ctil
• Status: Completed
• Phase: Phase 1
• First received: December 25, 2011
• Last updated: July 15, 2013
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

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

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

Locations

Country	Name	City	State
Israel	Schneider Medical Center	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in time spent in hypoglycemia		4 weeks (end of study period)	Yes
Primary	Parental fear of hypoglycemia		4 weeks ( end of study pariod)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Average and median of blood glucose levels		4 weeks (end of study period)	No
Secondary	Percentage of time spent below 63 mg/dl		4 weeks (end of study period)	Yes
Secondary	Percentage of time spent above 140,180,250 mg/dl		4 weeks (end of study period)	No
Secondary	Glucose variability	Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"	4 weeks (end of study period)	No
Secondary	Hypoglycemic events-number and severity of episodes		4 weeks (end of study period)	Yes