Type 1 Diabetes
Conditions
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.
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
DEVICEAbbott Continuous Dual Glucose Ketone Monitoring System
Participant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care
Sponsors
Abbott Diabetes Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged at least 2 years old at the time of study enrollment. 2. Diagnosis of type 1 diabetes with at least 12 months of diabetes medical history. 3. In the investigator's opinion, the participant is willing to wear the sensor, follow study specific instructions, and perform all study tasks. 4. 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
1. 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. 2. 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. 3. Participant is currently in another clinical study which may affect glucose or ketone management (or does so during the study). 4. Participant is unsuitable for participation due to any other cause as determined by the investigator. 5. Participant has implanted medical devices such as pacemakers or requires dialysis or is critically ill.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 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. |
Countries
New Zealand
Contacts
CONTACTMohamed Nada Director, Clinical Affairs, PhD
STUDY_DIRECTORShridhara Alva, PhD
Abbott Diabetes Care Inc
Outcome results
None listed