Evaluating the Occurrence of DKA in People With Type I Diabetes
1 other identifier
observational
1,200
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2026
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2026
CompletedFirst Posted
Study publicly available on registry
July 31, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2027
July 31, 2026
July 1, 2026
1.2 years
July 28, 2026
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Objective
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.
12 months
Study Arms (1)
Type I Diabetic patients using a Continuous Dual Glucose Ketone Sensor (DGK) Monitoring System
This is a multicentre, single arm, prospective, observational clinical study to determine DKA episodes in adult and pediatric people living with type 1 diabetes who will manage their diabetes by use of a Continuous Dual Glucose Ketone (DGK) sensor for 3 months
Interventions
Participant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care
Eligibility Criteria
Type I Diabetic patients
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Optimal Clinical Trials (North)
Rosedale, Auckland, 0632, New Zealand
New Zealand Clinical Research
Christchurch, Christchurch Central City, 8011, New Zealand
Health New Zealand-Southern
Dunedin, Otago, 9016, New Zealand
Optimal Clinical Trials
Auckland, 1010, New Zealand
Aotearoa Diabetes Collective
Hamilton, 3204, New Zealand
Te Pae Hauora o Ruahine o Tararua /MidCentral Health New Zealand
Palmerston North, 4414, New Zealand
New Zealand Clinical Research
Wellington, 6011, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shridhara Alva, PhD
Abbott Diabetes Care Inc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2026
First Posted
July 31, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
All information concerning the ADC devices and ADC operations, such as ADC patent applications, formulas, manufacturing processes, basic scientific data, and formulation information supplied by ADC and not previously published, are considered confidential by ADC.