Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

Evaluation of the Hypoglycaemia Notification Device Hyposafe H02 - the Pilot 2 Study - in Subjects With Type 1 Diabetes

To evaluate the technical performance of the hyposafe H02 during everyday activities and during insulin-induced hypoglycaemia, in addition to safety issues associated with the implantation and use of the hyposafe H02 in subjects with type 1 diabetes.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: hyposafe H02

Detailed Description

While a finger prick test accurately measures the blood glucose level, it does not provide continuous measurements and hence it is unreliable as a hypoglycaemia notification. Recent studies have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe hypoglycaemia. However, some find these devices troublesome to use and are annoyed by the inaccuracy of the measurements and even after short-term use the coverage in subgroups of patients is as low as 50% of the time. Thus, there is a medical need for a reliable hypoglycaemia notification which is easy and convenient to use and with high sensitivity and high rate of positive prediction.

This clinical investigation is designed to evaluate the sensitivity and the positive predictive value of the Hyposafe H02 in subjects with type 1 diabetes during everyday activities and during insulin-induced hypoglycaemia. In addition, the investigation provides information regarding safety and usability of the device. This to verify that the Hyposafe H02 works as intended in subjects with type 1 diabetes before proceeding with a larger study in subjects with type 1 diabetes.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark
    • North Zealand Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent obtained before any study related activities
• Type 1 diabetes diagnosed at least five years prior to inclusion in the study
• Impaired awareness and/or history of at least one severe hypoglycaemia within the preceding year

Exclusion Criteria:

• Severe cardiac disease
• History of stroke or cerebral haemorrhage and any other structural cerebral disease
• Active cancer or cancer diagnosis within the past 5 years
• Uraemia defined as s-creatinine ≥ 3 times upper reference value
• Liver disease defined as s-ALAT ≥ 3 times upper reference interval
• Epilepsy
• Use of antiepileptic drugs for any indication
• Clinically important hearing impairment
• Use of active implantable medical device including pacemaker and ICD-unit and cochlear implant
• Use of following drugs: Chemotherapeutic drugs of any kind, Methotrexate, Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
• Contraindications to the local anaesthetic used during implantation
• Known or suspected abuse of alcohol or any other neuro-active substances
• Infection at the site of device implantation
• Any haemorrhagic disease
• Females of childbearing potential who are pregnant or intend to become pregnant or are not using adequate contraceptive methods throughout the study
• Performing extreme sport, including scuba diving (snorkel diving is allowed) or parachute jumping
• Incapable of understanding the subject information or unlikely to complete the study for any reason
• Operating MRI scanners
• Operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military)
• Working at broadcast stations for television or FM/DAB radio
• Use of CGM or FGM with visible glucose measurements and activated glucose notifications
• Involved in therapies with medical devices that deliver electrical energy into the area around the implant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hyposafe H02; All subjects included are assigned to hyposafe H02-testing	Device: hyposafe H02; hypoglycaemia notification device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Number of spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated spontaneous hypoglycaemic episodes. Validation was performed by self-measured blood glucose (SMBG).	3 months
Positive Predictive Value	Number of validated spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of notification from the hyposafe H02. Validation was performed by self-measured blood glucose (SMBG).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Sensitivity	Total number of hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated hypoglycaemic episodes. Validation was performed by self-measured blood glucose (SMBG) or plasma glucose (PG).	3 months
Overall Positive Predictive Value	Total number of validated hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02. Validation was performed by self-measured blood glucose (SMBG) or plasma glucose (PG).	3 months
Sensitivity During Insulin-induced Hypoglycaemia	Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes.	2 days
Positive Predictive Value for Insulin-induced Hypoglycaemia	Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02	2 days
Number of Participants With a Satisfactory EEG Quality Test	The EEG quality test was performed twice in the study. At start up and at the end of the study. Evaluation was based on visual review of EEG of known phenomena and artefacts by an experienced EEG reviewer.	start up and after 3 months
Change in Impedance (kOhm) Over Time	The EEG performance was measured as the impedance as a function of time. An impedance value below 5 kOhm is considered very good. Number of participants with impedance values below 5 kOhm and no change over time is reported.	start up and after 3 months
Device Deficiencies	Total number of device deficiencies	4 months
Mean Glucose Level at the Time of a Hypoglycaemia Notification	Glucose levels were measured at the time of a hypoglycaemia notification during an outpatients settings (the spontaneous episodes) and during insulin-induced hypoglycaemia (the insulin-induced episodes)	3 months
Development in Discomfort Over Time Based on Questionnaires	Implant discomfort over time were evaluated at 3 time points; on average 3 weeks, 7 weeks and 15 weeks after implantation (baseline). Here the categories were converted into cardinal numbers: ranging from strongly agree=5 to strongly disagree=1 on the statement ''The implant has not caused discomfort in the past two days'.	3 weeks, 7 weeks and 15 weeks after implantation (baseline)
User Satisfaction Based on Questionnaire	User satisfaction were evaluated as to whether the subjects wished to continue to use the device	1 month
Mean Number of Hours of Use Per Device	Mean number of hours of use per device is measured as recording time of device	3 months
Response to Hypoglycaemia Notification	Response to hypoglyceamia notifications measured as the participants were able to take preventive actions upon notification of hypoglycaemia in an outpatient settings (the spontaneous hypoglycemic episodes) and during insulin-induced hypoglycaemia	3 months
Alarm Fatigue Based on Questionnaire	The participants were given a questionnaire regarding their preferences for sensitivity and false alarms at the end of the study. Reporting are for preferences during the day.	3 months

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Investigators: Principal Investigator: Ulrik Pedersen-Bjergaard, MD, PhD, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2016
• Primary Completion (Actual): August 29, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimated): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hypoglycaemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: Pilot 2 Diabetes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The main findings of study will be submitted for publication in a peer reviewed journal or made publically available at www.clinicaltrials.gov