Clinical trial NCT01509157: MDRS for Prevention of Nocturnal Hypoglycemia
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Continuous Glucose Monitoring
Nocturnal Hypoglycemia
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Reduction in time spent in hypoglycemia
timeFrame: 4 weeks (end of study period)
measure: Parental fear of hypoglycemia
timeFrame: 4 weeks ( end of study pariod)
Secondary outcomes:
measure: Change in Treatment Satisfaction
timeFrame: between week 0 (baseline) and week 4 (end of study period)
measure: Percentage of time spent in the target range
timeFrame: 4 weeks (end of study period)
measure: Percentage of time spent in the tight normal range
timeFrame: 4 weeks (end of study period)
measure: Average and median of blood glucose levels
timeFrame: 4 weeks (end of study period)
measure: Percentage of time spent below 63 mg/dl
timeFrame: 4 weeks (end of study period)
measure: Percentage of time spent above 140,180,250 mg/dl
timeFrame: 4 weeks (end of study period)
measure: Glucose variability
timeFrame: 4 weeks (end of study period)
measure: Hypoglycemic events-number and severity of episodes
timeFrame: 4 weeks (end of study period)
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Schneider Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.