Type 1 Diabetes Trial, Recruiting NCT07296276 Sponsor: i-SENS, Inc. Condition: Type 1 Diabetes
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Type 1 Diabetes Trial, Recruiting

NCT07296276
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 18 and 65 years of age (inclusive)
  • People with type 1 diabetes who have been using intensive insulin therapy — either multiple daily injections or an insulin pump (with or without a continuous glucose monitor that automatically adjusts insulin doses) — for at least 3 months
  • People who choose to take part willingly and sign a written consent form

Who may not be able to join:

  • People who have certain skin conditions or skin changes at the area where the glucose sensor would be placed, including severe psoriasis, recent burns or severe sunburn, severe eczema, severe scarring, large tattoos, dermatitis herpetiformis, severe rash, or a Staphylococcus aureus (staph) skin infection
  • People who have had an allergic skin reaction to medical adhesives (the sticky part of medical patches or devices)
  • People with a history of frequent abscesses (painful infected lumps) at insulin pump catheter sites
  • People who have had a severe low blood sugar episode in the 3 months before screening — defined as losing consciousness or having a seizure that required emergency medical treatment
  • People who cannot feel or recognise the warning signs of low blood sugar (a condition called hypoglycemia unawareness)
  • People with conditions that make low blood sugar more likely, such as untreated or poorly managed thyroid or adrenal disease
  • People who have had diabetic ketoacidosis (a serious diabetes complication) in the 3 months before screening
  • People with a history of epilepsy or fainting episodes in the 6 months before screening
  • People with unstable blood vessel or heart conditions — including stroke, mini-stroke (TIA), heart disease, poor circulation in the legs, or serious irregular heartbeat — where symptoms have occurred or worsened in the last 6 months, or where treatment is not adequate
  • People with anaemia (low haemoglobin / low red blood cell levels)
  • People who are scheduled to have an X-ray, MRI, CT scan, or diathermy (a heat-based medical treatment) during the study period
  • Women who are pregnant, breastfeeding, planning to become pregnant, or not willing to use an adequate method of contraception during the study
  • People who are currently in another clinical study, have been in one within the 2 weeks before screening, or plan to join another study that the trial doctor believes could affect safety or results
  • People who are unwilling to avoid eating certain foods (listed in a study document called Appendix 3) beyond the amounts allowed in the study
  • People with cognitive difficulties (problems with thinking, memory, or understanding), or anyone the trial doctor considers unsuitable or at increased risk from taking part
  • People who wear a pacemaker or similar implanted medical device
  • People whose HbA1c (a measure of average blood sugar over roughly 3 months) is above 9.5%
  • People who have a close personal or professional relationship with the study sponsor or the trial doctor that could create a conflict of interest
  • People who are unwilling or unable to follow the study procedures as required

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
i-SENS, Inc.
Registry
ClinicalTrials.gov
Start date
9 February 2026
Est. completion
30 April 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Accuracy of the glucose concentration measurements

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov