RecruitingEarly Phase 1

Simultaneous Measurement and Responsive Treatment - Part 2

Canada40 participantsStarted 2026-05-19

Plain-language summary

This research study is testing an investigational dual-port insulin patch pump that integrates a continuous glucose monitor (CGM) in adults with type 1 diabetes. The goal of the study is to better understand how insulin delivery near a CGM sensor affects glucose readings and to collect data to support development of a combined insulin pump and CGM system. People with type 1 diabetes require lifelong insulin therapy. Many use insulin pumps and CGMs, but these systems usually involve wearing multiple devices at different body sites. Managing several devices can increase treatment burden and may contribute to skin irritation, device failures, and challenges with glucose control. This study is conducted in two in-patient parts. In Part A, participants will wear three investigational devices at the same time while glucose levels are closely monitored using laboratory blood tests and a commercial CGM. This part of the study is designed to measure how basal and bolus insulin delivery near the CGM sensor affects sensor accuracy and how quickly the sensor signal recovers after insulin delivery. In Part B, participants will wear one investigational device while trained study staff use CGM information from the integrated sensor to guide insulin delivery recommendations generated by an automated glucose control algorithm. Insulin delivery decisions will be closely supervised, and glucose levels will be frequently monitored. Participants will stay at the clinical research center for short, controlled study visits. Safety will be monitored throughout the study, with predefined procedures for treating low or high blood sugar. The information collected will be used to support further development of an integrated insulin pump and CGM system for people with type 1 diabetes.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Early Phase 1 and seems to be testing how accurately a new CGM device called the DPP sensor reads glucose levels compared to a lab reference standard — does that mean it's primarily a device accuracy study rather than a treatment study, and what would that mean for my own diabetes management while I'm participating?
2The trial measures how the DPP CGM sensor behaves right after a bolus insulin delivery, including how far off its readings can get and how long it takes to recover — how significant could those temporary inaccuracies be for my safety if I were making dosing decisions during that window?
3Since this is an Early Phase 1 study, what is actually known so far about the DPP CGM device's reliability and safety, and are there any risks specific to wearing or using this device that I should understand before considering participation?
4The study compares the new DPP sensor against the Dexcom G7 and a lab blood glucose test called YSI — would I be switching away from my current CGM during the trial, and how might that affect my day-to-day blood sugar control?
5Given that this trial is focused on measuring device accuracy rather than testing a new treatment, would you recommend I consider this alongside — or instead of — other options that might more directly address my Type 1 diabetes management goals right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose

Timeframe: During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.

Time to maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose

Timeframe: During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.

Time to full recovery of DPP CGM sensor signal following bolus insulin delivery

Timeframe: During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.

Percent of DPP CGM sensor values meeting 20/20 agreement criteria vs reference glucose

Timeframe: Part A in-patient period (Day 1 to Day 2), with primary comparison during the clamp and intensive monitoring period.

Percent time in glucose ranges based on Dexcom G7 (Time in Range / Time Below / Time Above)

Timeframe: Part B in-patient period (approximately 2.5 days; Day 1 and Day 2, and combined across Part B).

Mean absolute relative difference (MARD) of DPP CGM vs reference glucose

Timeframe: Part B in-patient period (Day 1 and Day 2, and combined across Part B).

Trial details

NCT IDNCT07655076

SponsorClinSurge Research

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Karri Venn, BSc

647 274 4133 karri.venn@clinsurge.ca

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials