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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-30

Study Completion Date

2027-04-30

Brief Summary

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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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Detailed Description

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

Conditions

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Type 1 Diabetes (T1D)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking will be used.

Study Groups

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People with type 1 diabetes on insulin pump

Group Type EXPERIMENTAL

Temporary Insulin Suspension

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Temporary Insulin Suspension

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

Intervention Type BEHAVIORAL

Glucose and ketone sensor

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No