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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMahla Poudineh

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Temporary Insulin Suspension
  • Glucose and ketone sensor

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mahla Poudineh

Lead sponsor

University of Waterloo

Sponsor institution

Stanford University

Collaborator