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NCT Number: NCT06977633

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

The goal of this study is to evaluate a CGM-CKM device during insulin suspension in patients with type 1 diabetes. 10 patients with T1D will be recruited for a pilot study. The patients will visit CTRU at Stanford Medical School. The CGM-CKM device will be applied to the upper arm area of patients and baseline ketone and glucose measurement will be performed for one hour prior to suspending or disconnecting the pump. Upon baseline measurement, the pump will be disconnected for 3 hours while the electrochemical signals are collected from the CGM-CKM device. During the 3 hours of pump disconnection, blood samples will be collected every 5 minutes from participants for analyzing their insulin and glucagon using conventional ELISA kits and glucose and ketone using standard meters.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Temporary Insulin Suspension

Behavioral

Participants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision.

Glucose and ketone sensor

Device

The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.

Primary outcomes

  1. Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose

    Time frame: 5 hours

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

  2. Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones

    Time frame: 5 hours

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

Secondary outcomes

  1. Plasma Insulin Concentration Measured by Mercodia ELISA Assay

    Time frame: 5 hours

    Insulin concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.

  2. Plasma Glucagon Concentration Measured by Mercodia ELISA Assay

    Time frame: 5 hours

    Glucagon concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.

Study contacts

Contact information is provided by the study sponsor or research team.

Rayhan Lal, MD

CONTACT

[email protected]

650-498-7351

Ryan Kingman

CONTACT

[email protected]

650-736-4417

Sponsors and collaborators

Lead sponsor

Mahla Poudineh

Other

Collaborators

  • Stanford University

Registry information

Official study title

A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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