Type 1 DiabetesICU-TeleCGMNCT07769138
Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)
An observational study of Type 1 Diabetes and Type 2 Diabetes Treated With Insulin, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit. The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes Treated With Insulin, Hyperglycemia
- What is being tested?
- Dexcom G7 and ViewsEMR telemetry
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2026to Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults admitted to the intensive care unit with hyperglycaemia
Who may be able to join
- Age >18years inclusive
- Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
- Admission to ICU within 48hours
Who cannot join
- Known significant allergy to tape/ adhesives
- Imminent death or anticipated length of stay <24hours
- Women who are pregnant
- Imminent extracorporeal membrane oxygenation (ECMO)
- Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit. The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.
Read the detailed description
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
- Phase 1: A single arm (non-randomised) unmasked feasibility study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry. This phase will be conducted at a single site at Imperial College Healthcare NHS Trust (ICHNT).
- Phase 2: A randomised, parallel-group pilot study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry compared to standard of care. This phase will be conducted at three hospitals within the same site: ICHNT (St Mary's Hospital, Charing Cross Hospital and Hammersmith Hospital). The study will be conducted at Imperial College Healthcare NHS Trust in people with hyperglycaemia on admission to ICU requiring insulin.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes Treated With Insulin, Hyperglycemia, Intensive Care (ICU), Continuous Glucose Monitoring, Hypoglycaemia
- Being tested
- Dexcom G7, ViewsEMR telemetry
- Keywords
- diabetes, hyperglycaemia, hypoglycaemia, intensive care unit, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia, Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G7Device
Continuous glucose monitoring.
ViewsEMR telemetryDevice
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®) | Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®) Receives: Device: Dexcom G7; Device: ViewsEMR telemetry | |
| Usual care + masked Dexcom G7 | Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®) Receives: Device: Dexcom G7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Eligible participants that consent to participate.
Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
Measured: Throughout Phase 1 study period, up to 6 months
Phase 1: Time from admission to ICU to initiation of CGM
Time in minutes from admission to ICU to initiation of CGM
Measured: From admission to ICU to initiation of CGM, up to 48 hours
Phase 1: Time from consent to initiation of CGM
Time from consent to initiation of CGM
Measured: From enrollment to the end of intervention at 10 days
Phase 1: Percentage of CGM data availability for each participant
Percentage of CGM data availability for each participant
Measured: From enrollment to the end of intervention at 10 days
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Measured: From enrollment to the end of intervention at 10 days
Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use)
Number of premature sensor failures per participant (defined as <70% of anticipated use)
Measured: From enrollment to the end of intervention at 10 days
Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Measured: From enrollment to the end of intervention at 10 days
Phase 1: Proportion of participants completing the study
Proportion of participants completing the study
Measured: Throughout Phase 1 study period, up to 6 months
Phase 1: Proportion of nursing staff completing study survey
Proportion of nursing staff completing study survey
Measured: Throughout Phase 1 study period, up to 6 months
Phase 2: Number of episodes of hypoglycaemia per participant
Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
Measured: Throughout Phase 2, up to 30 days
Secondary outcomes (1)
Phase 1: Safety Outcomes
- Duration of CGM signal loss (units: minutes)
Measured: From enrollment to the end of intervention, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769138
- Sponsor's protocol ID
- 167867
- Acronym
- ICU-TeleCGM
- Status last verified
- Aug 2026
- First submitted
- 29 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Ethics approval does not allow sharing of individual participant data
Publications
Wexler DJ, Meigs JB, Cagliero E, Nathan DM, Grant RW. Prevalence of hyper- and hypoglycemia among inpatients with diabetes: a national survey of 44 U.S. hospitals. Diabetes Care. 2007 Feb;30(2):367-9. doi: 10.2337/dc06-1715. No abstract available.
PubMed 17259511Dhatariya KK, Umpierrez G. Gaps in our knowledge of managing inpatient dysglycaemia and diabetes in non-critically ill adults: A call for further research. Diabet Med. 2023 Mar;40(3):e14980. doi: 10.1111/dme.14980. Epub 2022 Nov 16.
PubMed 36256494Tomlin AM, Tilyard MW, Dovey SM, Dawson AG. Hospital admissions in diabetic and non-diabetic patients: a case-control study. Diabetes Res Clin Pract. 2006 Sep;73(3):260-7. doi: 10.1016/j.diabres.2006.01.008. Epub 2006 Feb 28.
PubMed 16504336Sarkisian S, Fenton TR, Shaheen AA, Raman M. Parenteral nutrition-associated hyperglycemia in noncritically ill inpatients is associated with higher mortality. Can J Gastroenterol. 2010 Jul;24(7):453-7. doi: 10.1155/2010/718526.
PubMed 20652162Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
PubMed 16449265Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.
PubMed 11889147Hulkower RD, Pollack RM, Zonszein J. Understanding hypoglycemia in hospitalized patients. Diabetes Manag (Lond). 2014 Mar;4(2):165-176. doi: 10.2217/DMT.13.73.
PubMed 25197322Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.
PubMed 19502209Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127.
PubMed 19564471Cook CB, Kongable GL, Potter DJ, Abad VJ, Leija DE, Anderson M. Inpatient glucose control: a glycemic survey of 126 U.S. hospitals. J Hosp Med. 2009 Nov;4(9):E7-E14. doi: 10.1002/jhm.533.
PubMed 20013863Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
PubMed 21737469Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.
PubMed 28118454Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
PubMed 28118453Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.
PubMed 28389582Litchman ML, Allen NA. Real-Time Continuous Glucose Monitoring Facilitates Feelings of Safety in Older Adults With Type 1 Diabetes: A Qualitative Study. J Diabetes Sci Technol. 2017 Sep;11(5):988-995. doi: 10.1177/1932296817702657. Epub 2017 Apr 5.
PubMed 28376647
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)
- ClinicalTrials.gov ID
- NCT07769138
- Acronym / sponsor ID
- ICU-TeleCGM / 167867
- Conditions
- Type 1 Diabetes, Type 2 Diabetes Treated With Insulin, Hyperglycemia, Intensive Care (ICU), Continuous Glucose Monitoring, Hypoglycaemia
- Keywords
- diabetes, hyperglycaemia, hypoglycaemia, intensive care unit, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Aug 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.
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit. The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.
Detailed description
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
- Phase 1: A single arm (non-randomised) unmasked feasibility study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry. This phase will be conducted at a single site at Imperial College Healthcare NHS Trust (ICHNT).
- Phase 2: A randomised, parallel-group pilot study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry compared to standard of care. This phase will be conducted at three hospitals within the same site: ICHNT (St Mary's Hospital, Charing Cross Hospital and Hammersmith Hospital). The study will be conducted at Imperial College Healthcare NHS Trust in people with hyperglycaemia on admission to ICU requiring insulin.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®) | – | Device: Dexcom G7, Device: ViewsEMR telemetryAdjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®) |
| Usual care + masked Dexcom G7 | – | Device: Dexcom G7Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the intensive care unit with hyperglycaemia
Key inclusion criteria (3 listed)
- Age >18years inclusive
- Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
- Admission to ICU within 48hours
Key exclusion criteria (5 listed)
- Known significant allergy to tape/ adhesives
- Imminent death or anticipated length of stay <24hours
- Women who are pregnant
- Imminent extracorporeal membrane oxygenation (ECMO)
- Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest
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 |
|---|---|---|
| Dexcom G7Continuous glucose monitoring. | Device | Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®), Usual care + masked Dexcom G7 |
| ViewsEMR telemetryViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends | Device | Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®) |
Primary outcome
Phase 1: Eligible participants that consent to participate.
Time frame: Throughout Phase 1 study period, up to 6 months
Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
Phase 1: Time from admission to ICU to initiation of CGM
Time frame: From admission to ICU to initiation of CGM, up to 48 hours
Time in minutes from admission to ICU to initiation of CGM
Phase 1: Time from consent to initiation of CGM
Time frame: From enrollment to the end of intervention at 10 days
Time from consent to initiation of CGM
Phase 1: Percentage of CGM data availability for each participant
Time frame: From enrollment to the end of intervention at 10 days
Percentage of CGM data availability for each participant
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Time frame: From enrollment to the end of intervention at 10 days
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use)
Time frame: From enrollment to the end of intervention at 10 days
Number of premature sensor failures per participant (defined as <70% of anticipated use)
Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Time frame: From enrollment to the end of intervention at 10 days
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
Phase 1: Proportion of participants completing the study
Time frame: Throughout Phase 1 study period, up to 6 months
Proportion of participants completing the study
Phase 1: Proportion of nursing staff completing study survey
Time frame: Throughout Phase 1 study period, up to 6 months
Proportion of nursing staff completing study survey
Phase 2: Number of episodes of hypoglycaemia per participant
Time frame: Throughout Phase 2, up to 30 days
Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
1 secondary outcome
Phase 1: Safety Outcomes
Time frame: From enrollment to the end of intervention, up to 10 days
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 17 Aug 2026.
- Background: PubMed 17259511Wexler DJ, Meigs JB, Cagliero E, Nathan DM, Grant RW. Prevalence of hyper- and hypoglycemia among inpatients with diabetes: a national survey of 44 U.S. hospitals. Diabetes Care. 2007 Feb;30(2):367-9. doi: 10.2337/dc06-1715. No abstract available.
- Background: PubMed 36256494Dhatariya KK, Umpierrez G. Gaps in our knowledge of managing inpatient dysglycaemia and diabetes in non-critically ill adults: A call for further research. Diabet Med. 2023 Mar;40(3):e14980. doi: 10.1111/dme.14980. Epub 2022 Nov 16.
- Background: PubMed 16504336Tomlin AM, Tilyard MW, Dovey SM, Dawson AG. Hospital admissions in diabetic and non-diabetic patients: a case-control study. Diabetes Res Clin Pract. 2006 Sep;73(3):260-7. doi: 10.1016/j.diabres.2006.01.008. Epub 2006 Feb 28.
- Background: PubMed 20652162Sarkisian S, Fenton TR, Shaheen AA, Raman M. Parenteral nutrition-associated hyperglycemia in noncritically ill inpatients is associated with higher mortality. Can J Gastroenterol. 2010 Jul;24(7):453-7. doi: 10.1155/2010/718526.
- Background: PubMed 16449265Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
- Background: PubMed 11889147Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.
- Background: PubMed 25197322Hulkower RD, Pollack RM, Zonszein J. Understanding hypoglycemia in hospitalized patients. Diabetes Manag (Lond). 2014 Mar;4(2):165-176. doi: 10.2217/DMT.13.73.
- Background: PubMed 19502209Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.
- Background: PubMed 19564471Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127.
- Background: PubMed 20013863Cook CB, Kongable GL, Potter DJ, Abad VJ, Leija DE, Anderson M. Inpatient glucose control: a glycemic survey of 126 U.S. hospitals. J Hosp Med. 2009 Nov;4(9):E7-E14. doi: 10.1002/jhm.533.
- Background: PubMed 21737469Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
- Background: PubMed 28118454Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.
- Individual participant dataSharing planned: No. Ethics approval does not allow sharing of individual participant data
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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.
1 site 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 and Type 2 Diabetes Treated With Insulin, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 3 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 17 Aug 2026. 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 Kingdom. 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 Parizad Avari, MBBS, PhD (020 33133706, p.avari@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Eligible participants that consent to participate. (time frame: Throughout Phase 1 study period, up to 6 months). The study lists 10 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 NCT07769138, which also lists 32 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 17 Aug 2026.