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

NCT06977633 | Not Yet Recruiting FDA Device

• 1 other identifier: 76354
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (2)

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

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

  5 hours

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

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

  5 hours

Secondary Outcomes (2)

• Plasma Insulin Concentration Measured by Mercodia ELISA Assay

  5 hours

• Plasma Glucagon Concentration Measured by Mercodia ELISA Assay

  5 hours

Study Arms (1)

People with type 1 diabetes on insulin pump

EXPERIMENTAL

Behavioral: Temporary Insulin Suspension; Device: Glucose and ketone sensor

Interventions

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.

People with type 1 diabetes on insulin pump

Glucose and ketone sensor DEVICE

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

People with type 1 diabetes on insulin pump

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahla Poudineh: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• Ausri IR, Sadeghzadeh S, Biswas S, Zheng H, GhavamiNejad P, Huynh MDT, Keyvani F, Shirzadi E, Rahman FA, Quadrilatero J, GhavamiNejad A, Poudineh M. Multifunctional Dopamine-Based Hydrogel Microneedle Electrode for Continuous Ketone Sensing. Adv Mater. 2024 Aug;36(32):e2402009. doi: 10.1002/adma.202402009. Epub 2024 Jun 16.

  PMID: 38847967 RESULT

• GhavamiNejad P, GhavamiNejad A, Zheng H, Dhingra K, Samarikhalaj M, Poudineh M. A Conductive Hydrogel Microneedle-Based Assay Integrating PEDOT:PSS and Ag-Pt Nanoparticles for Real-Time, Enzyme-Less, and Electrochemical Sensing of Glucose. Adv Healthc Mater. 2023 Jan;12(1):e2202362. doi: 10.1002/adhm.202202362. Epub 2022 Oct 13.

  PMID: 36183355 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Rayhan Lal, MD

CONTACT

650-498-7351; inforay@stanford.edu

Ryan Kingman

CONTACT

650-736-4417; rkingman@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking will be used.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-group, non-randomized study designed to evaluate the accuracy of an investigational continuous glucose ketone sensor in participants with type 1 diabetes. Under controlled inpatient conditions, sensor readings will be compared to reference standards for blood glucose and ketone levels. The study does not include therapeutic interventions or real-time clinical decision-making based on sensor output.

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 18, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)