Nocturnal Hypoglycemia, Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Hypoglycemia detection, Non-invasive sensor, Nocturnal hypoglycemia
Brief summary
Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device. The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods The proposed study will be consisting of two main segments: The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer. The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events. During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced. The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events. During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).
Interventions
DEVICEHypo-Sense (non invasive sensor)
Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
Sponsors
Night Sense Ltd
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signing an inform consent form prior to any trial related procedure * Type 1 diabetes diagnosed at least 12 months prior to study inclusion * Age \> 18 years old
Exclusion criteria
* Participating in other device or drug study * Any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study * Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease * Chronic skin problem in the lower inner arm * Pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study) | Sensitivity of the Hypo Sense-the proportion of hypoglycemia events detected by the Hypo Sense sensor from total number of hypoglycemic events detected by reference capillary glucometer |
| Positive Predictive Value of the hypo-Sense | At final visit ( week 4 for participants at segment 1 of the study and week 6 for participants at segment 2 of the study) | Positive Predictive Value of the hypo sense- the proportion of validated (true) hypoglycemia events detected by the hypo sense sensor from total alerts detected by the Hypo-Sense sensor |
Countries
Israel
Outcome results
None listed