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Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 and up

Near-sensor insulin delivery with CGM in people with type 1 diabetes

Official title: Simultaneous Measurement and Responsive Treatment - Part 2

Run by ClinSurge Research · NCT07655076 · Data updated 2026-11-12

A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

More Type 1 Diabetes trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment40 (estimated)
SponsorClinSurge Research
Research network
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedMay 19, 2026
Main results expectedSeptember 1, 2026
Study endsDecember 1, 2026
Registry record updatedJune 23, 2026
Trial IDNCT07655076 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults ≥18 years with type 1 diabetes for at least 12 months, on multiple daily injections or continuous subcutaneous insulin infusion (including automated systems), with a total daily insulin dose between 30 and 100 IU.

Probably not a fit

People outside the specified insulin dose range or not using subcutaneous insulin therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm study tests an investigational dual-port pump that combines insulin delivery with a nearby CGM sensor in adults with type 1 diabetes. Part A focuses on sensor characterization by having participants wear three devices to measure how basal and bolus insulin near the CGM influences readings. Part B explores the feasibility and performance of an automated glycaemic control algorithm using the integrated system. The study is conducted in two sequential inpatient sessions to gather data on sensor accuracy and system usability. Primary aims include understanding CGM reading changes due to insulin delivery and collecting data to optimize a sensor recovery monitoring algorithm.

Why it matters

Potential benefit: If successful, the integrated pump-CGM approach could reduce device burden and improve glucose management for people with type 1 diabetes.

How similar studies have gone: Previous attempts to integrate sensing and delivery show promise, but this exact dual-port approach with near-sensor insulin delivery is exploratory and early feasibility.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria Part A:

* Males and females ≥ 18 years of age.
* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.
* Total daily insulin dose (TDD) between 30 and 100 IU.

Inclusion Criteria Part B:

* Males and females ≥ 18 years of age.
* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Undergoing continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.
* Totally daily insulin dose (TDD) between 30 and 100 IU.

Exclusion Criteria (A and B):

* Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
* Failure to comply with the study protocol or with the team's recommendations.
* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).
* Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study. Pregnancy will be verified by urine dipstick testing at the time of admission visit.
* Severe hypoglycemic episode within one month of admission.
* Severe diabetic ketoacidosis episode within one month of admission.
* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
* Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
* Current or ≤ one month use of supraphysiological doses of systemic glucocorticoids
* Pronounced lipohypertrophy in the abdominal subcutaneous adipose tissue, which may impair sensor function or insulin infusion.
* Insufficient abdominal surface area to support the wearing of three DPP systems in Part A.

Where it's running

  • ClinSurge Research
    Toronto, Ontario, Canada     Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.