Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status

Readout, Inc.

Status

Completed

Conditions

Ketosis

Ketogenic Dieting

Treatments

Diagnostic Test: Breath ketone testing

Diagnostic Test: Blood ketone testing

Study type

Observational

Funder types

Industry

Identifiers

RO-0001

Details and patient eligibility

About

The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Ketogenic diet cohort: currently following a ketogenic or low-carbohydrate diet defined as less than 30 grams per day (ketogenic) or less than 100 grams per day (low-carbohydrate) as estimated by the individual. Subjects must have been following the diet before the beginning of the study period and must continue with the diet throughout the duration of the trial.
High-carbohydrate diet cohort: currently following a diet that does not restrict dietary carbohydrate. Carbohydrate consumption should be greater than 100 grams per day as estimated by the individual. Subjects must have been following the diet before the study period and must continue with the diet throughout the duration of the trial.

Exclusion criteria

Type-1 diabetes
Insulin-dependent type-2 diabetes
History of diabetic ketoacidosis
Currently taking Warfarin or other blood thinners
Currently taking a sodium-glucose cotransporter-2 (SGLT2) inhibitor
Currently taking Disulfiram
Unwilling to maintain their diet during the study period
Unwilling to test blood and breath ketones five times per day
Non-English speaking
Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.