ClinicalTrials.gg
Not yet recruitingNCT07739342Updated Jul 31, 2026

Evaluating the Occurrence of DKA in People With Type I Diabetes

An observational study in Type 1 Diabetes, sponsored by Abbott Diabetes Care. Not yet recruiting at 7 sites in New Zealand. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Abbott Diabetes Care (part of Abbott) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Abbott Diabetes Care is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Type I Diabetic patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Device: Abbott Continuous Dual Glucose Ketone Monitoring System

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

06

What researchers measure

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 months

07

Study locations

7 sites
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07739342
Responsible party
Sponsor
First posted
Jul 31, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Mohamed Nada Director, Clinical Affairs, PhD
Contact
mohamed.nada@abbott.com
510-749-5416
Shridhara Alva, PhD
study director · Abbott Diabetes Care Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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