Evaluating the Occurrence of DKA in People With Type I Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abbott Continuous Dual Glucose Ketone Monitoring System.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Occurrence of DKA in People With Type 1 Diabetes
Overview
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.
Detailed description
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.
Interventions
- Device Abbott Continuous Dual Glucose Ketone Monitoring System
Participant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care
Primary outcome measures
- Primary Objective [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
New Zealand · 7 centers
- Optimal Clinical Trials (North) — Rosedale
- New Zealand Clinical Research — Christchurch
- Health New Zealand-Southern — Dunedin
- Optimal Clinical Trials — Auckland
- Aotearoa Diabetes Collective — Hamilton
- Te Pae Hauora o Ruahine o Tararua /MidCentral Health New Zealand — Palmerston North
- New Zealand Clinical Research — Wellington
Identifiers
NCT: NCT07739342 · ADC-US-RES-25280