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Type 1 Diabetes MellitusSPEEDNCT07679347

Safety and Performance Evaluation of the SAVA Continuous Glucose Monitor for Effective Glucose Detection

A study testing CGM Devices in people with Type 1 Diabetes Mellitus, run by SAVA Technologies Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
CGM Devices
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Aug 2026to Sep 2026
Phase
Interventional
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

Who may be able to join

  • The participant is willing and able to give informed consent to participate in the study.
  • The participant is at least 18 years of age at the time of enrolment.
  • The participant has a clinical diagnosis of Type 1 diabetes, with 7% < HbA1C < 10% within the last 6 months, for a minimum of 6 months duration prior to enrolment, as determined by a medical record by an individual qualified to make a medical diagnosis, and is using insulin (either by an insulin pump, subcutaneous injections, and/or inhaled insulin) for at least 6 months prior to enrolment.
  • If participant is using noninsulin glucose-lowering medications (such as SGLT2I Inhibitor, Metformin, or other), dose has been stable for at least 2 weeks prior to screening.
  • The participant body weight is at least 110 pounds, in accordance with U.S. Department of Health and Human Services guidance for blood collection.
  • The participant has adequate venous access as assessed by an investigator or appropriate centre staff.
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  • The participant is available to attend all three up to 8-hour, clinically supervised, in-clinic sessions and to have multiple venous and capillary blood samples collected.
  • The participant agrees to not consume Vitamin C for the duration of the study.
  • The participant is prepared to record details related to their participation (e.g. meals, finger prick times, device incidents, comfort) daily.
  • The participant is prepared to wear up to three blinded investigational devices, and one unblinded investigational device for 15 days.
  • In the investigators' opinion, are suitable for participation in the study.
  • The participant is able to read and understand English.
  • The participant is willing to return the research devices at the end of the study.
  • The participant is willing to manage diabetes with insulin during study visits as they would do otherwise.
  • The participant can commit to not getting the CGMs wet for the first 12 hours after application, such as by showering or swimming.

Who cannot join

  • The participant gave birth within the last 6 months, is pregnant, is trying to conceive or is not willing and able to practice birth control during the study duration.
  • The participant has serious concomitant disorders or diseases (e.g. history of hypoglycaemia with unawareness requiring third party assistance, coagulation disorders) that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.
  • The participant has had a recent cardiovascular event or major surgery in the last 6 months that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.
  • The participant has been admitted to the hospital with Diabetic Ketoacidosis in the last 6 months prior to enrolment.
  • The participant has donated more than 500mL of blood in the past 4 weeks.
  • The participant has a blood haemoglobin (Hb) that is 10% or more below the normal reference range for men and women, at the discretion of the Investigator.
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  • Current use of sulfonylurea medications.
  • Current use of GLP-1 Receptor Agonist medications.
  • The participant has an implanted medical device such as a pacemaker or an implantable cardioverter-defibrillator (ICD).
  • The participant has multiple tattoos, scars, active skin condition or wound, or significant dermatitis overlying the skin where devices are likely to be placed.
  • The participant has a known allergy or sensitivity to skin adhesives or sensor materials.
  • The participant is taking part in another interventional clinical study requiring blood sampling, an investigational drug or device during the 15-day wear period of this study.
  • The participant is not willing to suspend their hybrid closed loop (Automated Insulin Delivery) system during the clinic sampling session.
  • The participant has any X-ray or MRI scheduled at any time during the participation of the study.
  • Any other reason which, in the investigator's opinion, would compromise participant safety or data integrity.

About this study

The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes. This is a pilot study, so the main purposes are to collect preliminary data for future studies, assess comfort and safety, and explore the accuracy of the CGM against references and benchmarks.

Being tested
CGM Devices
Keywords
Type 1 Diabetes Mellitus, Continuous Glucose Monitor
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.

  • CGM DevicesDevice

    Each participant will wear 3 SAVA CGMs and 1 commercially available CGM

Study groups in NCT07679347
Study groupRoleWhat they receive
CGM ArmExperimentalNot described
Receives: Device: CGM Devices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paired Sensor-Venous Blood Glucose Readings

    The primary outcome is at least 98% of all paired sensor-venous blood glucose reference readings fall within the clinically acceptable Zones A and B of the Clarke Error Grid.

    Measured: For the duration of time the participant is wearing the CGM device (Day 0 to Day 14; up to 15 days)

Secondary outcomes (5)

  1. Assessment of comfort associated with devices at insertion and removal

    Assess participant-reported comfort and pain associated with sensor application and removal using the Numeric Pain Rating Scale which measures participants' pain level on a scale of 0 to 10 where higher scores mean worse pain.

    Measured: At device application (Day 0) and removal (up to Day 14)

  2. Assessment of duration of pain associated with devices at insertion and removal

    Assess participant-reported comfort and pain associated with sensor application and removal using the Pain Duration Scale which measures participants' pain level at different time points (within 5 seconds, 5-30 seconds, more than 30 seconds) after sensor application or removal, on a scale of 0 to 10 where higher scores mean worse pain.

    Measured: At device application (Day 0) and removal (up to Day 14)

  3. Evaluation of skin response at device wear sites

    Characterise the skin and evaluate skin response at sensor wear sites before and after device removal using the Draize Scale where higher scores mean worse skin response.

    Measured: At device application (Day 0) and removal (up to Day 14)

  4. Characterisation of the safety profile of the SAVA CGMs

    Characterise the safety profile of the SAVA CGM in terms of adverse events and device deficiencies. The number, type, and severity of adverse events and device deficiencies will be evaluated.

    Measured: Up to 15 days (Day 14)

  5. Description of SAVA CGM clinical safety profile

    Describe the clinical safety profile of the SAVA CGM based on the percentage distribution of paired sensor-reference glucose readings across zones of the Consensus (Parkes) Error Grid.

    Measured: Up to 15 days (Day 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07679347
Sponsor's protocol ID
SPEED-SUB-002
Acronym
SPEED
Status last verified
Jul 2026
First submitted
17 Jun 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CGM Devices in people with Type 1 Diabetes Mellitus, run by SAVA Technologies Ltd..

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 15 inclusion and 15 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Paired Sensor-Venous Blood Glucose Readings (time frame: For the duration of time the participant is wearing the CGM device (Day 0 to Day 14; up to 15 days)). 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 NCT07679347.

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 7 Jul 2026.

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