MDRS for Prevention of Nocturnal Hypoglycemia

Clalit Health Services

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Procedure: Continuous Glucose Monitoring; Device: MDRS System (Remote & Safety diabetes management system)

Study type: Interventional

Funder types: Other

Identifiers

NCT01509157

rmc006447ctil

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 4 to 24 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

MDRS system

Experimental group

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

Treatment:

Device: MDRS System (Remote & Safety diabetes management system)

Continuous Glucose Monitoring

Active Comparator group

Description:

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

Treatment:

Procedure: Continuous Glucose Monitoring