Evaluating the Occurrence of DKA in People With Type I Diabetes
ConditionType 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorAbbott Diabetes Care
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
Type I Diabetic patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Abbott Continuous Dual Glucose Ketone Monitoring System
DeviceParticipant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care
Treatment groups
1,200 Participants
are divided into 1 treatment groupGroup A: Type I Diabetic patients using a Continuous Dual Glucose Ketone Sensor (DGK) Monitoring System1 intervention
Trial outcomes
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: