RightFit
Not yet recruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests an upper-arm device that tracks blood sugar and ketones, chemicals made when the body breaks down fat. It is for 10 people with type 1 diabetes who use an insulin pump. At Stanford Medical School, the pump will be disconnected for 3 hours, with blood samples taken every 5 minutes during that time.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had type 1 diabetes for at least 1 year, and your body makes little or no insulin.
  • Currently use an insulin pump.
  • Understand the study, agree to follow its steps, and sign a form agreeing to take part.
  • Agree to sign a form allowing your medical information to be shared when you join.
  • Can speak, read, and write in the language used by the study team.

Who can't join

  • Had diabetic ketoacidosis (a dangerous buildup of acids called ketones) or severely low blood sugar in the past 6 months.
  • Have an eGFR below 45 (a measure of how well your kidneys filter blood) or another serious kidney problem.
  • Are pregnant or breastfeeding.
  • Take medicines other than insulin that affect ketone levels, including medicines called SGLT2 inhibitors.
  • Have a skin infection or condition where the sensor would be placed.
  • Have a known skin allergy to tape or glue used to hold devices in place.
  • Currently use any long-acting insulin analogs, a type of long-lasting insulin.
  • Have a medical condition that the study doctor thinks could keep you from finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

CA