NCT03165110 is a NA clinical trial of Onyx BG Meter / App System in Diabetes Mellitus, sponsored by Ascensia Diabetes Care.

Who is sponsoring NCT03165110?

NCT03165110 is sponsored by Ascensia Diabetes Care.

What drugs are being tested in NCT03165110?

Interventions in NCT03165110: Onyx BG Meter / App System.

What condition does NCT03165110 study?

NCT03165110 studies Diabetes Mellitus.

Is NCT03165110 still recruiting?

NCT03165110 is currently completed. Last updated 4 June 2019.

Are results published for NCT03165110?

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

Last reviewed 2019-06-04 · How we verify

NCT03165110

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

Evaluation of an Ascensia Diabetes Care Blood Glucose Meter and App System

Completed NA Results posted Last updated 4 June 2019

What this trial tests

NA trial testing Onyx BG Meter / App System in Diabetes Mellitus in 47 participants. Completed in 12 May 2017.

Timeline

17 March 2017

Primary endpoint
12 May 2017

12 May 2017

Quick facts

Lead sponsor	Ascensia Diabetes Care
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	47
Start date	17 March 2017
Primary completion	12 May 2017
Estimated completion	12 May 2017
Sites	1 location across United States

Drugs / interventions tested

Onyx BG Meter / App System

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Ascensia Diabetes Care

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus. 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.

Percent of Responses From Persons With Diabetes That 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success With Syncing the Reading on the Onyx Glucose Meter and App. Primary · 6 weeks

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the success of syncing the blood glucose value on the meter with the App for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	89.13

Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Accessing and Using Smart Reminders Feature in the Onyx App System Primary · 6 weeks

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on accessing and using the Smart Reminders feature in the Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.Recognize and use "Smart Reminders"

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	26
Users of the Onyx Blood Glucose Meter/ App System at Home	20

Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success at Accessing the Expanded Graph and My Readings View in the Onyx App System Primary · 6 weeks

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to access the Expanded Graph and My Readings views in Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	46

Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Interpreting the Expanded Graph and My Readings View in the Onyx App System Primary · 6 weeks

Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to interpret the Expanded Graph and My Readings views in Onyx the App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	45

Change in HbA1c% From Study Start to End of Study Secondary · 6 weeks

Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study). The average change of HbA1c for all subjects at Visit 1 were compared to the average change of HbA1c for all subjects at Visit 2. Lower scores are better outcomes.

Site Visit 1

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	7.7273003	5.6 – 11

Site Visit 2

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	7.6993933	5.6 – 11

Change in Fructosamine (µmol/L) From Study Start to End of Study Secondary · 6 Weeks

Laboratory reports were used to compare fructosamine results from subjects at visit 1 with frustosamine results at Visit 2 (end of study).

Visit 1

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	332.8	211 – 555

Visit 2

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	322.7	211 – 555

Average Change in Subject Body Weight From Study Start to End of Study Secondary · 6 weeks

The average change in subject body weight from study start (Visit 1) to end of study (Visit 2).

Site Visit 1

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	194.4	± 59.51

Site Visit 2

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	193.8	± 59.30

Average Change in Subject BMI From Study Start to End of Study Secondary · 6 weeks

Subject BMI results at visit 1 were compared with BMI results at Visit 2 (end of study).

Site Visit 1

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	29.723913	± 0.10903799

Site Visit 2

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	29.636304	± 0.10903799

Average Change in Total Daily Insulin Dose From Study Start to End of Study Secondary · 6 weeks

A Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).

Site Visit 1

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	76.869565	± 1.4668160

Site Visit 2

Group	Value	95% CI
Users of the Onyx Blood Glucose Meter/ App System at Home	78.326087	± 1.4668160

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Users of the Onyx Blood Glucose Meter/ App System at Home

Serious: 0/46 (0%)

Deaths: 0/46

Other adverse events (2 terms — click to expand)

Reaction	System	Users of the Onyx Blood Gl…
Shoulder pain	Musculoskeletal and connective tissue disorders	—
Bladder Infection	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT03165110 adverse events section.

Sponsor's own description

The purpose of this study is to assess the utility of the Contour Diabetes App 2.0 when used with the Contour Next One meter (the Onyx system).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07392437 — Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and I · NA · recruiting
NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
NCT06918977 — Improving Glycemic Control With Telemedicine and Smart Insulin Pens · NA · recruiting

Other Ascensia Diabetes Care trials

Trials by the same sponsor.

NCT06053593 — Ketostix® and Keto-Diastix® Performance Study · completed
NCT05449795 — Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults · completed
NCT05467345 — Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples · completed
NCT05647824 — User Performance of the TV4 BGMS · completed
NCT04033315 — Performance of the L-PLUS BGMS by Persons With Diabetes Mellitus · 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 NCT03165110 (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 Ascensia Diabetes Care
Last refreshed: 4 June 2019

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/NCT03165110.

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

NCT03165110

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetes Mellitus

Other Ascensia Diabetes Care trials

Verify against primary sources