Prevention of Nocturnal Hypoglycemia in Children and Young Adults With Type 1 Diabetes Using a Remote Safety and Control Diabetes Management System

Rabin Medical Center1 site in 1 country38 target enrollmentJanuary 2012

ConditionsType 1 Diabetes

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Rabin Medical Center
Enrollment: 38
Locations: 1
Primary Endpoint: Parental fear of hypoglycemia
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rabin Medical Center

Responsible Party

Sponsor

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.

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

Outcomes

Primary Outcomes

Parental fear of hypoglycemia

Time Frame: 4 weeks ( end of study pariod)

Reduction in time spent in hypoglycemia

Time Frame: 4 weeks (end of study period)

Secondary Outcomes

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))
Percentage of time spent in the tight normal range(4 weeks (end of study period))
Change in Treatment Satisfaction(between week 0 (baseline) and week 4 (end of study period))
Average and median of blood glucose levels(4 weeks (end of study period))
Percentage of time spent in the target range(4 weeks (end of study period))
Glucose variability(4 weeks (end of study period))
Hypoglycemic events-number and severity of episodes(4 weeks (end of study period))