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Feasibility Study of a Continuous Glucose-Ketone Monitoring Device for Type 1 Diabetes

This study is testing a new device called a continuous glucose-ketone monitoring (CGM-CKM) sensor in people with type 1 diabetes. The goal is to see how well this device measures glucose (blood sugar) and ketones compared to standard methods. You might be able to join if you are 18 to 65 years old, have had type 1 diabetes for at least a year, and use an insulin pump. The study will involve temporarily stopping your insulin pump for up to 3 hours while wearing the new sensor. Researchers will compare the sensor's readings to blood tests to see if it's accurate. This is a small pilot study with 10 participants.

Study design
This is an interventional study with 10 participants. It is testing a new device, the continuous glucose-ketone monitoring (CGM-CKM) sensor.
What's involved
You would visit Stanford Medical School, wear the CGM-CKM device for 4 hours, and temporarily suspend your insulin pump for up to 3 hours. During this time, blood samples will be collected every 5 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for glucose and ketones are taken at 5 hours after the start of the study procedures.

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NCT06977633

Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes

Not Yet Recruiting
NAAges 18–65InterventionalDiagnostic
Mahla Poudineh
~10 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Temporary Insulin SuspensionGlucose and ketone sensor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose
Measured over 5 hours
+1 more outcome measured

Conditions

Type 1 Diabetes (T1D)

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Who to contact

Rayhan Lal, MD
[email protected]
650-498-7351
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Clinical diagnosis of type 1 diabetes for at least 1 year without significant endogenous insulin production
Currently using insulin pump
Understanding and willingness to follow the protocol and sign informed consent.
Willingness to sign a consent for release of medical information at the time of enrollment
Ability to speak, read and write in the language of the investigators.

Exclusion

History of DKA or severe hypoglycemia within the past 6 months
eGFR \<45 mL/min/1.73 m2 or other significant renal impairment
Pregnancy or breastfeeding
Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors
Active skin infections or conditions affecting sensor application sites
Known skin allergies to tapes or adhesives
Current use of any long-acting insulin analogs
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol

What this trial measures

  • Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose5 hours

    Correlation between glucose concentrations (mmol/L) measured by the CGM-CKM sensor and plasma glucose concentrations measured with YSI 2300 glucose analyzer.

  • Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones5 hours

    Correlation between ketone concentrations (mmol/L) measured by the experimental CKM-CKM sensor and blood ketone concentrations measured using commercially available tests.