Type 1 DiabetesNCT07739342
Evaluating the Occurrence of DKA in People With Type I Diabetes
An observational study of Type 1 Diabetes, run by Abbott Diabetes Care at 7 sites in New Zealand.
Trial 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 more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Abbott Continuous Dual Glucose Ketone Monitoring System
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 7 sitesNew Zealand
- Study dates
- Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type I Diabetic patients
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
New Zealand7 sites
Optimal Clinical Trials
Auckland, 1010
Nah Y Baik, MD, +64 9 303 4987, Tina@optimalclinicaltrials.com
Kim AU, +64 9 303 4987, Kim.a@optimalclinicaltrials.com
New Zealand Clinical Research
Christchurch, Christchurch Central City, 8011
Martin deBock, MD, +64 (0) 211956579, martin.debock@otago.ac.nz
Jo Sanders, +6433729477, jo.sanders@nzcr.co.nz
Health New Zealand-Southern
Dunedin, Otago, 9016
Benjamin Wheeler, MD, 0064223279429, ben.wheeler@otago.ac.nz
Ben Wheeler, MD
Aotearoa Diabetes Collective
Hamilton, 3204
Ryan Y Paul, MD, 07 834 0189, ryan.paul@tewhatuora.govt.nz
Te Pae Hauora o Ruahine o Tararua /MidCentral Health New Zealand
Palmerston North, 4414
Helen Snell, MD, helen.snell@midcentraldhb.govt.nz
Optimal Clinical Trials (North)
Rosedale, Auckland, 0632
Claudette Lionnet, MD, +64 9 303 4987, Claudette@optimalclinicaltrials.com
Kshemina Mhaskar, +64 9 303 4987, kshemina@optimalclinicaltrials.com
New Zealand Clinical Research
Wellington, 6011
Dr. Jian Hui Feng, MD, 6421338986, David.Feng@nzcr.co.nz
Trish Smith, +64 4 333 1726, Trish.Smith@nzcr.co.nz
About this study
Official title: Evaluating the Occurrence of DKA in People With Type 1 Diabetes
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Abbott Continuous Dual Glucose Ketone Monitoring System
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Continuous Dual Glucose Ketone Monitoring SystemDevice
Participant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Abbott Continuous Dual Glucose Ketone Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shridhara Alva, PhD, Study director, Abbott Diabetes Care Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739342
- Sponsor's protocol ID
- ADC-US-RES-25280
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Occurrence of DKA in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07739342
- Acronym / sponsor ID
- ADC-US-RES-25280
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type I Diabetic patients using a Continuous Dual Glucose Ketone Sensor (DGK) Monitoring System | – | Device: Abbott Continuous Dual Glucose Ketone Monitoring SystemThis 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type I Diabetic patients
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott Continuous Dual Glucose Ketone Monitoring SystemParticipant will utilize the Abbott Continuous Dual Glucose Ketone Monitoring System in place of the Standard of Care | Device | Type I Diabetic patients using a Continuous Dual Glucose Ketone Sensor (DGK) Monitoring System |
Primary outcome
Primary Objective
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shridhara Alva, PhD study director
Abbott Diabetes Care Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Abbott Diabetes Care at 7 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Nada Director, Clinical Affairs, PhD (510-749-5416, mohamed.nada@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.