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Completed

NCT Number: NCT01509157

MDRS for Prevention of Nocturnal Hypoglycemia

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Schneider Medical Center

Petah Tikva, 49202, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDRS System (Remote & Safety diabetes management system)

Device

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

Continuous Glucose Monitoring

Procedure

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

Primary outcomes

  1. Reduction in time spent in hypoglycemia

    Time frame: 4 weeks (end of study period)

  2. Parental fear of hypoglycemia

    Time frame: 4 weeks ( end of study pariod)

Secondary outcomes

  1. Change in Treatment Satisfaction

    Time frame: between week 0 (baseline) and week 4 (end of study period)

    We will measure the change in Treatment Satisfaction using questioner and calculation of the the satisfaction score

  2. Percentage of time spent in the target range

    Time frame: 4 weeks (end of study period)

    Percentage of time spent in the target range, defined as sensor glucose level within 63-140 mg/dl

  3. Percentage of time spent in the tight normal range

    Time frame: 4 weeks (end of study period)

    Percentage of time spent in the tight normal range, defined as sensor glucose level within 80 to 120 mg/dl

  4. Average and median of blood glucose levels

    Time frame: 4 weeks (end of study period)

  5. Percentage of time spent below 63 mg/dl

    Time frame: 4 weeks (end of study period)

  6. Percentage of time spent above 140,180,250 mg/dl

    Time frame: 4 weeks (end of study period)

  7. Glucose variability

    Time frame: 4 weeks (end of study period)

    Glucose variability measured by glucose Standard Deviation and "Kovatchev indexes"

  8. Hypoglycemic events-number and severity of episodes

    Time frame: 4 weeks (end of study period)

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Acronym: MDRS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2012
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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