Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07739342

Evaluating the Occurrence of DKA in People With Type I Diabetes

This study will evaluate the occurrences of Diabetes-related Ketoacidosis (DKA) in adult and pediatric individuals living with Type I diabetes while managing diabetes with Abbott's Continuous Monitoring Systems.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Optimal Clinical Trials (North), Rosedale, Auckland, New Zealand

Loading trial locations.

About this study

The purpose of this study is to understand the occurrence of DKA in people with type 1 diabetes which will subsequently inform the benefit of continuous glucose and ketone monitoring in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged at least 2 years old at the time of study enrollment.
  • Diagnosis of type 1 diabetes with at least 12 months of diabetes medical history.
  • In the investigator's opinion, the participant is willing to wear the sensor, follow study specific instructions, and perform all study tasks.
  • Willing and able to provide written signed and dated informed consent (adults) or participant's parent/legal guardian must be willing and able to provide written signed and dated informed consent along with assent form completed by the participant for those mature enough to make their own decisions per investigator assessment (those less than 16 years of age).

Exclusion criteria

  • In the investigator's opinion, the participant has a known (or suspected) allergy to medical grade adhesives at enrollment that would interfere with participant completing study required activities.
  • In the investigator's opinion, the participant has concomitant medical condition(s) which could interfere with the study or present a risk to the safety or welfare of the participant or study staff.
  • Participant is currently in another clinical study which may affect glucose or ketone management (or does so during the study).
  • Participant is unsuitable for participation due to any other cause as determined by the investigator.
  • Participant has implanted medical devices such as pacemakers or requires dialysis or is critically ill.

Treatment and study plan

Abbott Continuous Dual Glucose Ketone Monitoring System

Device

Participant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care

Primary outcomes

  1. Primary Objective

    Time frame: 12 months

    Occurrence of Diabetes-related Ketoacidosis (DKA) in adult and pediatric individuals living with type 1 diabetes while managing diabetes with the Abbott's Continuous Dual Glucose Ketone Monitoring System.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Nada Director, Clinical Affairs, PhD

CONTACT

[email protected]

510-749-5416

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

Evaluating the Occurrence of DKA in People With Type 1 Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.