NCT02925676 is a NA clinical trial of hyposafe H02 in Diabetes Mellitus, Type 1, sponsored by UNEEG Medical A/S.

Who is sponsoring NCT02925676?

NCT02925676 is sponsored by UNEEG Medical A/S.

What drugs are being tested in NCT02925676?

Interventions in NCT02925676: hyposafe H02.

What condition does NCT02925676 study?

NCT02925676 studies Diabetes Mellitus, Type 1.

Is NCT02925676 still recruiting?

NCT02925676 is currently terminated. Last updated 26 July 2024.

Are results published for NCT02925676?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-26 · How we verify

NCT02925676

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

Terminated NA Results posted Last updated 26 July 2024

What this trial tests

NA trial testing hyposafe H02 in Diabetes Mellitus, Type 1 in 8 participants. Terminated before completion.

Timeline

5 October 2016

Primary endpoint
29 August 2018

10 September 2018

Quick facts

Lead sponsor	UNEEG Medical A/S
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	8
Start date	5 October 2016
Primary completion	29 August 2018
Estimated completion	10 September 2018
Sites	2 locations across Denmark

Drugs / interventions tested

hyposafe H02

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

UNEEG Medical A/S

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity Primary · 3 months

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).

Sensitivity (day)

Group	Value	95% CI
Overall Study: Hyposafe H02	100

Sensitivity (night)

Group	Value	95% CI
Overall Study: Hyposafe H02	100

Positive Predictive Value Primary · 3 months

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).

Positive predictive value (day)

Group	Value	95% CI
Overall Study: Hyposafe H02	8

Positive predictive value (night)

Group	Value	95% CI
Overall Study: Hyposafe H02	2

Overall Sensitivity Secondary · 3 months

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).

Group	Value	95% CI
Overall Study: Hyposafe H02	81

Overall Positive Predictive Value Secondary · 3 months

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).

Group	Value	95% CI
Overall Study: Hyposafe H02	11

Sensitivity During Insulin-induced Hypoglycaemia Secondary · 2 days

Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes.

Group	Value	95% CI
Overall Study: Hyposafe H02	57

Positive Predictive Value for Insulin-induced Hypoglycaemia Secondary · 2 days

Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02

Group	Value	95% CI
Overall Study: Hyposafe H02	100

Number of Participants With a Satisfactory EEG Quality Test Secondary · start up and after 3 months

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.

Group	Value	95% CI
Overall Study: Hyposafe H02	7

Change in Impedance (kOhm) Over Time Secondary · start up and after 3 months

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.

Group	Value	95% CI
Overall Study: Hyposafe H02	7

Device Deficiencies Secondary · 4 months

Total number of device deficiencies

Group	Value	95% CI
Overall Study: Hyposafe H02	15

Mean Glucose Level at the Time of a Hypoglycaemia Notification Secondary · 3 months

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)

Spontanous episodes

Group	Value	95% CI
Overall Study: Hyposafe H02	2.4	1.9 – 3.8

Insulin-induced episodes

Group	Value	95% CI
Overall Study: Hyposafe H02	2	1.7 – 2.6

Development in Discomfort Over Time Based on Questionnaires Secondary · 3 weeks, 7 weeks and 15 weeks after implantation (baseline)

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 after implantation

Group	Value	95% CI
Overall Study: Hyposafe H02	4.1	3 – 5

7 weeks after implantation

Group	Value	95% CI
Overall Study: Hyposafe H02	4.7	4 – 5

15 weeks after implantation

Group	Value	95% CI
Overall Study: Hyposafe H02	4.9	4 – 5

User Satisfaction Based on Questionnaire Secondary · 1 month

User satisfaction were evaluated as to whether the subjects wished to continue to use the device

Group	Value	95% CI
Overall Study: Hyposafe H02	2
Overall Study: Hyposafe H02	5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event were collected in a period of 17 weeks for each participant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Overall Study: Hyposafe H02

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (11 terms — click to expand)

Reaction	System	Overall Study: Hyposafe H02
Implant site pain	General disorders	—
Skin infection	Skin and subcutaneous tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Ear pain	Ear and labyrinth disorders	—
Implant site hyperesthesia	Nervous system disorders	—
Hypoglycaemia	Endocrine disorders	—
Thooth infection	Infections and infestations	—
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	—
Urinary tract infection	Infections and infestations	—
Influenza	Infections and infestations	—
Renal stone removal	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT02925676 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

Other UNEEG Medical A/S trials

Trials by the same sponsor.

NCT05495386 — Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes · NA · withdrawn
NCT06934005 — Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II · NA · completed
NCT05111847 — Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part I · NA · completed
NCT04526418 — Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lo · NA · terminated
NCT04513743 — Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02925676 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNEEG Medical A/S
Last refreshed: 26 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02925676.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing