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Taking people in CanadaEarly phase 1

Testing a Combined Insulin Pump and Glucose Sensor in Adults With Type 1 Diabetes

Tests one patch that gives insulin and reads glucose in adults.

Key facts

Who runs it
ClinSurge Research
Where
Toronto, CanadaSee the site
Trial code
Registry title
Simultaneous Measurement and Responsive Treatment - Part 2
Status
Recruiting
Phase
Early phase 1
People taking part
40 people, planned
Started
19 May 2026
Expected to end
1 Dec 2026
Type of study
Interventional
Treatments tested
  • DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)
Record updated
23 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 diabetes who use insulin injections or an insulin pump. They stay at a research center for short, supervised visits.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Type 1 diabetes for at least 12 months. Total daily insulin dose between 30 and 100 IU.
Earlier treatment
Part A: multiple daily insulin injections or an insulin pump for at least 3 months. Part B: an insulin pump for at least 3 months. Automated insulin delivery systems are also allowed.

Main reasons for not taking part

  • Pregnant, breastfeeding, or unwilling to use effective contraception
  • Severe low blood sugar or severe diabetic ketoacidosis within 1 month before admission
  • Use of diabetes medicines other than insulin (within 1 month for GLP1-RA, within 1 week for all others)
  • Heart attack, acute coronary syndrome or heart surgery within the last 6 months
  • Clinically significant kidney, nerve or eye damage from diabetes

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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
  • 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

Who cannot take part

  • 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
  • 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 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
  • 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 in Canada

  • ClinSurge ResearchToronto, CanadaContact: Eden Stein, B.Sc, M.Sc, MBATaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Sensor Characterization and Automated Glycaemic ControlTreatment being tested

    Sensor characterization, Part "A": Participants will undergo a 1.5-day in-patient stay using the DPP System. The pump and the CGM functions of the DPP System are controlled by separate smartphone applications. Blood glucose will be monitored with a Yellow Springs Instruments (YSI) glucose analyzer and a separate commercial CGM (Dexcom G7 CGM System). Participants will also undergo euglycemic glucose clamp testing to assess sensor response to basal and bolus insulin delivery. Automated glycaemic control, "Part B": Participants will undergo a 2.5-day in-patient stay using the DPP System and an automated glycaemic control (AGC) algorithm. During this period, they will consume standardized meals and engage in standardized exercise to evaluate glucose control.

    Treatment: DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Simultaneous Measurement and Responsive Treatment - Part 2
Plain-language title
Testing a Combined Insulin Pump and Glucose Sensor in Adults With Type 1 DiabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
23 June 2026