Diabetes Mellitus, Type 1Phase 4NCT05541484
Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency
A Phase 4 study testing SGLT2 inhibitor and Biosense Breath Ketone Analyzer in people with Diabetes Mellitus, Type 1, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D). This is important for the potential use of sodium glucose co-transport inhibitors (SGLT2i) in persons with T1D. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- SGLT2 inhibitor and Biosense Breath Ketone Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2022to 23 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes for >1 year
- Age 18 - 75, any gender, race or ethnicity
- HbA1c <10%
- Stable insulin delivery method for the past 30 days
- Vision of 20/40 or better, including ability to read all device instructions and insulin pump settings
- Use of an insulin pump and ability to make adjustments to pump settings
Show all 12Show fewer
- Insulin delivery by MDI with basal insulin (glargine U100) given in the morning OR willingness to transition to basal glargine given in the morning for at least 48 hours prior to insulin withdrawal visits
- Use of personal CGM, only Dexcom G6 will be permitted for data consistency
- Use of cellular phone (iOS11 and above or Android) with data capability with connectivity to Dexcom Clarity app and Biosense Ketone Monitoring app
- Willing to share CGM, capillary ketone results and BrACE data with the study group
- Able to understand the study requirements, risks and benefits and able to provide written informed consent
- Able to schedule the visits and perform study related tasks
Who cannot join
- History of DKA in the past 6 months, or more than 1 episode of DKA in the past 2 years
- Use of insulin degludec, insulin glargine U300 or insulin detemir as basal insulin and unwilling to transition to glargine given in the morning for at least 48 hours before the insulin withdrawal visits
- Use of an SGLT2i in the past 30 days or intolerance to SGLT2i use in the past for any reason
- Unstable heart disease, including hospitalization for any cardiac or vascular event in the past 6 months.
- eGFR <30 ml/min/1.73m2 or hemoglobin <11.0 g/dL measured in the past year
- Cancer that has been under treatment in the past 6 months, or treatment is likely in the 3 months after signing the consent, not including skin cancer or cancers under long-term hormonal reduction treatment (breast or prostate, no other active treatment)
Show all 16Show fewer
- Psychiatric condition that interferes with daily activities or diabetes self-care, including substance abuse
- Any illness or condition that may interfere with study measurements, or contraindications for use of SGLT2i, based on investigator discretion (hemoglobinopathy, orthostatic hypotension)
- Unwilling to avoid alcohol during the active study periods, specifically to avoid alcohol for 4 hours prior to any breath ketone measurement
- Currently following or planning to adopt a diet that is low in carbohydrates (defined as <90 grams of carbohydrate per day) or is expected to be ketogenic
- Use of oral or injected corticosteroids within the past 30 days or planned during the study period
- Taking disulfiram (due to interference with breath ketone measurements)
- History of vomiting episodes for any reason in the past 30 days, or hospitalization for cyclic vomiting in the past year
- History of urinary tract infection in the past 3 months
- Pregnancy, breast-feeding or intention of becoming pregnant during the study time period and up to 30 days after study completion
- Pre-menopausal women not using acceptable birth control defined as abstinence, surgical sterilization, hysterectomy, hormonal contraception, IUD or proven effective barrier methods
Trial locations and contacts
1 site in 1 country.
About this study
This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D). This is important for the potential use of sodium glucose co-transport inhibitors (SGLT2i) in persons with T1D.
Read the detailed description
The study will consist of 4 distinct segments that include routine testing of ketones during usual care, during insulin deficiency, and while taking a SGLT2i in addition to usual care, then with insulin deficiency after the SGLT2i has reached steady state and ingested that morning, in a crossover design. We will study 20 adults with T1D who are using Dexcom G6 continuous glucose monitor (CGM), plus any form of insulin delivery. Simultaneous ketone monitoring using a the Biosense® breath ketone analyzer (BKA) and capillary blood beta hydroxybutyrate (BOHB) measurement will be done 2-3 times daily for 2 weeks during each of the outpatient segments. This will generate > 800 data points comparing breath acetone, measured in units called ACEs, versus capillary blood BOHB measurements for each 2 week period. On days of insulin withdrawal, which will take place on the Washington University Intensive Research Unit (IRU), frequent monitoring with capillary blood measurements of BOHB (Precision Xtra®, Abbott) will be compared with breath BrAce measurements (Biosense®, Readout) and laboratory measurements of BOHB and acetoacetate. Electrolytes and glucose will also be measured.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- SGLT2 inhibitor, Biosense Breath Ketone Analyzer
- Keywords
- ketosis, beta hydroxybutyrate, sodium glucose co-transport inhibitor, breath ketone
- Medical subject headings
- Diabetes Mellitus, Type 1, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called Dapagliflozin 10mg (Farxiga)
See above.
Biosense Breath Ketone AnalyzerDevice
The hand-held device tests ketones in exhaled breath
| Study group | Role | What they receive |
|---|---|---|
| Usual care (UC) or Dapagliflozin (DAPA) | Other | 20 persons with T1D Receives: Drug: SGLT2 inhibitor; Device: Biosense Breath Ketone Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary Blood Beta-hydroxybutyrate (BOHB) During Outpatient Care
Differences between usual care v dapagliflozin of capillary beta hydroxybutyrate (BOHB) measurements during outpatient care.
Measured: Measurements were taken 2-3 times daily for 2 weeks
Breath Acetone (BrACE) During Outpatient Care
Differences of breath acetone (BrACE) measurements between usual care v dapagliflozin during outpatient care.
Measured: Measurements were taken 2-3 times daily for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start14 Oct 2022
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- Participants will test the breath ketone analyzer under usual care or with usual care plus SGLT2i treatment. Each out patient segment will last two weeks. At the end of each out patient segment, participants will undergo a one-day insulin withdrawal period with more intense monitoring.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Janet B McGill, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541484
- Sponsor's protocol ID
- 202206078
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2022
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After all analyses have been completed and papers have been published, the investigators plan to share the IPD. Detailed plan will be forthcoming.
Publications
Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14.
PubMed 28919061Mathieu C, Dandona P, Gillard P, Senior P, Hasslacher C, Araki E, Lind M, Bain SC, Jabbour S, Arya N, Hansen L, Thoren F, Langkilde AM; DEPICT-2 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial. Diabetes Care. 2018 Sep;41(9):1938-1946. doi: 10.2337/dc18-0623. Epub 2018 Jul 19.
PubMed 30026335Owen OE, Trapp VE, Skutches CL, Mozzoli MA, Hoeldtke RD, Boden G, Reichard GA Jr. Acetone metabolism during diabetic ketoacidosis. Diabetes. 1982 Mar;31(3):242-8. doi: 10.2337/diab.31.3.242.
PubMed 6818074Garg SK, Peters AL, Buse JB, Danne T. Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol. Diabetes Technol Ther. 2018 Sep;20(9):571-575. doi: 10.1089/dia.2018.0246. Epub 2018 Aug 21. No abstract available.
PubMed 30129772Laffel L. Ketone bodies: a review of physiology, pathophysiology and application of monitoring to diabetes. Diabetes Metab Res Rev. 1999 Nov-Dec;15(6):412-26. doi: 10.1002/(sici)1520-7560(199911/12)15:63.0.co;2-8.
PubMed 10634967Hancock G, Sharma S, Galpin M, Lunn D, Megson C, Peverall R, Richmond G, Ritchie GAD, Owen KR. The correlation between breath acetone and blood betahydroxybutyrate in individuals with type 1 diabetes. J Breath Res. 2020 Oct 29;15(1):017101. doi: 10.1088/1752-7163/abbf37.
PubMed 33027776Suntrup Iii DJ, Ratto TV, Ratto M, McCarter JP. Characterization of a high-resolution breath acetone meter for ketosis monitoring. PeerJ. 2020 Sep 24;8:e9969. doi: 10.7717/peerj.9969. eCollection 2020.
PubMed 33024634Spanel P, Dryahina K, Rejskova A, Chippendale TW, Smith D. Breath acetone concentration; biological variability and the influence of diet. Physiol Meas. 2011 Aug;32(8):N23-31. doi: 10.1088/0967-3334/32/8/N01. Epub 2011 Jul 1.
PubMed 21725144Rydosz A. A Negative Correlation Between Blood Glucose and Acetone Measured in Healthy and Type 1 Diabetes Mellitus Patient Breath. J Diabetes Sci Technol. 2015 Jul;9(4):881-4. doi: 10.1177/1932296815572366. Epub 2015 Feb 17.
PubMed 25691653Herring RA, Shojaee-Moradie F, Garesse R, Stevenage M, Jackson N, Fielding BA, Mendis A, Johnsen S, Umpleby AM, Davies M, Russell-Jones DL. Metabolic Effects of an SGLT2 Inhibitor (Dapagliflozin) During a Period of Acute Insulin Withdrawal and Development of Ketoacidosis in People With Type 1 Diabetes. Diabetes Care. 2020 Sep;43(9):2128-2136. doi: 10.2337/dc19-2579. Epub 2020 Jul 8.
PubMed 32641376Patel NS, Van Name MA, Cengiz E, Carria LR, Weinzimer SA, Tamborlane WV, Sherr JL. Altered Patterns of Early Metabolic Decompensation in Type 1 Diabetes During Treatment with a SGLT2 Inhibitor: An Insulin Pump Suspension Study. Diabetes Technol Ther. 2017 Nov;19(11):618-622. doi: 10.1089/dia.2017.0267. Epub 2017 Oct 25.
PubMed 29068709Jones KE, Petersen MC, Markov AM, Salam M, Krutilova P, McKee AM, Bohnert KL, Adamson SE, McGill JB. Breath Acetone Correlates With Capillary beta-hydroxybutyrate in Type 1 Diabetes. J Diabetes Sci Technol. 2025 Apr 22:19322968251334640. doi: 10.1177/19322968251334640. Online ahead of print.
PubMed 40260699Jones KE, Petersen MC, Markov AM, Salam M, Krutilova P, McKee AM, Bohnert KL, Adamson SE, McGill JB. Breath Acetone Correlates with Capillary beta-hydroxybutyrate in Type 1 Diabetes. medRxiv [Preprint]. 2025 Jan 31:2025.01.30.25321320. doi: 10.1101/2025.01.30.25321320.
PubMed 39974120
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency
- ClinicalTrials.gov ID
- NCT05541484
- Acronym / sponsor ID
- 202206078
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- ketosis, beta hydroxybutyrate, sodium glucose co-transport inhibitor, breath ketone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D). This is important for the potential use of sodium glucose co-transport inhibitors (SGLT2i) in persons with T1D.
Detailed description
The study will consist of 4 distinct segments that include routine testing of ketones during usual care, during insulin deficiency, and while taking a SGLT2i in addition to usual care, then with insulin deficiency after the SGLT2i has reached steady state and ingested that morning, in a crossover design. We will study 20 adults with T1D who are using Dexcom G6 continuous glucose monitor (CGM), plus any form of insulin delivery. Simultaneous ketone monitoring using a the Biosense® breath ketone analyzer (BKA) and capillary blood beta hydroxybutyrate (BOHB) measurement will be done 2-3 times daily for 2 weeks during each of the outpatient segments. This will generate > 800 data points comparing breath acetone, measured in units called ACEs, versus capillary blood BOHB measurements for each 2 week period. On days of insulin withdrawal, which will take place on the Washington University Intensive Research Unit (IRU), frequent monitoring with capillary blood measurements of BOHB (Precision Xtra®, Abbott) will be compared with breath BrAce measurements (Biosense®, Readout) and laboratory measurements of BOHB and acetoacetate. Electrolytes and glucose will also be measured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will test the breath ketone analyzer under usual care or with usual care plus SGLT2i treatment. Each out patient segment will last two weeks. At the end of each out patient segment, participants will undergo a one-day insulin withdrawal period with more intense monitoring.
| Arm | Type | Receives |
|---|---|---|
| Usual care (UC) or Dapagliflozin (DAPA) | Other | Drug: SGLT2 inhibitor, Device: Biosense Breath Ketone Analyzer20 persons with T1D |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Type 1 diabetes for >1 year
- Age 18 - 75, any gender, race or ethnicity
- HbA1c <10%
- Stable insulin delivery method for the past 30 days
- Vision of 20/40 or better, including ability to read all device instructions and insulin pump settings
Key exclusion criteria (16 listed)
- History of DKA in the past 6 months, or more than 1 episode of DKA in the past 2 years
- Use of insulin degludec, insulin glargine U300 or insulin detemir as basal insulin and unwilling to transition to glargine given in the morning for at least 48 hours before the insulin withdrawal visits
- Use of an SGLT2i in the past 30 days or intolerance to SGLT2i use in the past for any reason
- Unstable heart disease, including hospitalization for any cardiac or vascular event in the past 6 months.
- eGFR <30 ml/min/1.73m2 or hemoglobin <11.0 g/dL measured in the past year
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 |
|---|---|---|
| SGLT2 inhibitorAlso: Dapagliflozin 10mg (Farxiga)See above. | Drug | Usual care (UC) or Dapagliflozin (DAPA) |
| Biosense Breath Ketone AnalyzerThe hand-held device tests ketones in exhaled breath | Device | Usual care (UC) or Dapagliflozin (DAPA) |
Primary outcome
Capillary Blood Beta-hydroxybutyrate (BOHB) During Outpatient Care
Time frame: Measurements were taken 2-3 times daily for 2 weeks
Differences between usual care v dapagliflozin of capillary beta hydroxybutyrate (BOHB) measurements during outpatient care.
Breath Acetone (BrACE) During Outpatient Care
Time frame: Measurements were taken 2-3 times daily for 2 weeks
Differences of breath acetone (BrACE) measurements between usual care v dapagliflozin during outpatient care.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28919061Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14.
- Background: PubMed 30026335Mathieu C, Dandona P, Gillard P, Senior P, Hasslacher C, Araki E, Lind M, Bain SC, Jabbour S, Arya N, Hansen L, Thoren F, Langkilde AM; DEPICT-2 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial. Diabetes Care. 2018 Sep;41(9):1938-1946. doi: 10.2337/dc18-0623. Epub 2018 Jul 19.
- Background: PubMed 6818074Owen OE, Trapp VE, Skutches CL, Mozzoli MA, Hoeldtke RD, Boden G, Reichard GA Jr. Acetone metabolism during diabetic ketoacidosis. Diabetes. 1982 Mar;31(3):242-8. doi: 10.2337/diab.31.3.242.
- Background: PubMed 30129772Garg SK, Peters AL, Buse JB, Danne T. Strategy for Mitigating DKA Risk in Patients with Type 1 Diabetes on Adjunctive Treatment with SGLT Inhibitors: A STICH Protocol. Diabetes Technol Ther. 2018 Sep;20(9):571-575. doi: 10.1089/dia.2018.0246. Epub 2018 Aug 21. No abstract available.
- Background: PubMed 10634967Laffel L. Ketone bodies: a review of physiology, pathophysiology and application of monitoring to diabetes. Diabetes Metab Res Rev. 1999 Nov-Dec;15(6):412-26. doi: 10.1002/(sici)1520-7560(199911/12)15:63.0.co;2-8.
- Background: PubMed 33027776Hancock G, Sharma S, Galpin M, Lunn D, Megson C, Peverall R, Richmond G, Ritchie GAD, Owen KR. The correlation between breath acetone and blood betahydroxybutyrate in individuals with type 1 diabetes. J Breath Res. 2020 Oct 29;15(1):017101. doi: 10.1088/1752-7163/abbf37.
- Background: PubMed 33024634Suntrup Iii DJ, Ratto TV, Ratto M, McCarter JP. Characterization of a high-resolution breath acetone meter for ketosis monitoring. PeerJ. 2020 Sep 24;8:e9969. doi: 10.7717/peerj.9969. eCollection 2020.
- Background: PubMed 21725144Spanel P, Dryahina K, Rejskova A, Chippendale TW, Smith D. Breath acetone concentration; biological variability and the influence of diet. Physiol Meas. 2011 Aug;32(8):N23-31. doi: 10.1088/0967-3334/32/8/N01. Epub 2011 Jul 1.
- Background: PubMed 25691653Rydosz A. A Negative Correlation Between Blood Glucose and Acetone Measured in Healthy and Type 1 Diabetes Mellitus Patient Breath. J Diabetes Sci Technol. 2015 Jul;9(4):881-4. doi: 10.1177/1932296815572366. Epub 2015 Feb 17.
- Background: PubMed 32641376Herring RA, Shojaee-Moradie F, Garesse R, Stevenage M, Jackson N, Fielding BA, Mendis A, Johnsen S, Umpleby AM, Davies M, Russell-Jones DL. Metabolic Effects of an SGLT2 Inhibitor (Dapagliflozin) During a Period of Acute Insulin Withdrawal and Development of Ketoacidosis in People With Type 1 Diabetes. Diabetes Care. 2020 Sep;43(9):2128-2136. doi: 10.2337/dc19-2579. Epub 2020 Jul 8.
- Background: PubMed 29068709Patel NS, Van Name MA, Cengiz E, Carria LR, Weinzimer SA, Tamborlane WV, Sherr JL. Altered Patterns of Early Metabolic Decompensation in Type 1 Diabetes During Treatment with a SGLT2 Inhibitor: An Insulin Pump Suspension Study. Diabetes Technol Ther. 2017 Nov;19(11):618-622. doi: 10.1089/dia.2017.0267. Epub 2017 Oct 25.
- Derived from this study: PubMed 40260699Jones KE, Petersen MC, Markov AM, Salam M, Krutilova P, McKee AM, Bohnert KL, Adamson SE, McGill JB. Breath Acetone Correlates With Capillary beta-hydroxybutyrate in Type 1 Diabetes. J Diabetes Sci Technol. 2025 Apr 22:19322968251334640. doi: 10.1177/19322968251334640. Online ahead of print.
- Individual participant dataSharing planned: Undecided. After all analyses have been completed and papers have been published, the investigators plan to share the IPD. Detailed plan will be forthcoming.
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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. This study is not recruiting at the moment.
Janet B McGill, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2 inhibitor and Biosense Breath Ketone Analyzer in people with Diabetes Mellitus, Type 1, run by Washington University School of Medicine at 1 site in United States.
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 12 inclusion and 16 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: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary Blood Beta-hydroxybutyrate (BOHB) During Outpatient Care (time frame: Measurements were taken 2-3 times daily for 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541484, which also lists 13 linked publications.
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 21 Feb 2025.