Type 1 Diabetes (T1D)NCT06977633
Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes
A study testing Temporary Insulin Suspension and Glucose and ketone sensor in people with Type 1 Diabetes (T1D), run by Mahla Poudineh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Temporary Insulin Suspension and Glucose and ketone sensor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 30 Sep 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94304
Rayhan Lal, MD, 925-727-1317, inforay@stanford.edu
Ryan Kingman, BS, 408-612-1720, rkingman@stanford.edu
About this study
Official title: A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM
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.
Read the detailed description
This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Temporary Insulin Suspension, Glucose and ketone sensor
- 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.
Temporary Insulin SuspensionBehavioural
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 sensorDevice
The participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| People with type 1 diabetes on insulin pump | Experimental | Not described Receives: Behavioral: Temporary Insulin Suspension; Device: Glucose and ketone sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 hours
Secondary outcomes (2)
Plasma Insulin Concentration Measured by Mercodia ELISA Assay
Insulin concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.
Measured: 5 hours
Plasma Glucagon Concentration Measured by Mercodia ELISA Assay
Glucagon concentration (pmol/L) in plasma samples collected during the study will be measured using Mercodia insulin ELISA assay.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start30 Jun 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahla Poudineh
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor-investigator, Mahla Poudineh, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977633
- Sponsor's protocol ID
- 76354
- Status last verified
- May 2025
- First submitted
- 18 Apr 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Sensor measurements and blood plasma levels will be shared via journal/conference publications.
Publications
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.
PubMed 38847967GhavamiNejad 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.
PubMed 36183355
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A pH-Responsive Hydrogel Microneedle Patch for Continuous Measurement of Ketone Bodies and Glucose: CGM-CKM
- ClinicalTrials.gov ID
- NCT06977633
- Acronym / sponsor ID
- 76354
- Conditions
- Type 1 Diabetes (T1D)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mahla PoudinehUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-significant risk (NSR) device study not conducted under an IDE, in accordance with 21 CFR 812.2(b)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| People with type 1 diabetes on insulin pump | Experimental | Behavioral: Temporary Insulin Suspension, Device: Glucose and ketone sensor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary Insulin SuspensionParticipants will suspend insulin delivery from their personal insulin pumps for up to 3 hours. Insulin suspension is temporary and participant-driven under supervision. | Behavioural | People with type 1 diabetes on insulin pump |
| Glucose and ketone sensorThe participants wear a prototype continuous glucose-ketone monitoring (CGM-CKM) device using painless hydrogel microneedles for 4 hours. | Device | People with type 1 diabetes on insulin pump |
Primary outcome
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.
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.
2 secondary outcomes
Plasma Insulin Concentration Measured by Mercodia ELISA Assay
Time frame: 5 hours
Plasma Glucagon Concentration Measured by Mercodia ELISA Assay
Time frame: 5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 38847967Ausri 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.
- Results publication: PubMed 36183355GhavamiNejad 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.
- Individual participant dataSharing planned: Yes. Sensor measurements and blood plasma levels will be shared via journal/conference publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Insulin Suspension and Glucose and ketone sensor in people with Type 1 Diabetes (T1D), run by Mahla Poudineh at 1 site in United States.
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 5 inclusion and 8 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Rayhan Lal, MD (650-498-7351, inforay@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose (time frame: 5 hours). The study lists 2 primary outcomes in all. 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 NCT06977633, which also lists 2 linked publications.
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 5 May 2026.