Recruiting
Early Phase 1

Insulin Patch Pump

Sponsor:

ClinSurge Research

Code:

NCT07655076

Conditions

Type 1 Diabetes Mellitus

T1D

Type 1 Diabetes

T1DM

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)

Study Details

Brief 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.

Conditions

Type 1 Diabetes Mellitus

T1D

Type 1 Diabetes

T1DM

Study ID

NCT07655076

Start date

May 19, 2026

Status verified date

Jun, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Sensor Characterization and Automated Glycaemic Control

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.

Interventions

DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)

Participants will use the DPP System, an integrated insulin pump and continuous glucose monitoring-based device, during inpatient study visits. The system will be evaluated under multiple study conditions, including sensor characterization procedures and automated glycaemic control during standardized meals and exercise.

Primary outcome measure

  • Maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Part B in-patient period (Day 1 and Day 2, and combined across Part B). ]
  • Mean absolute deviation (MAD) of DPP CGM vs reference glucose by basal rate [ Time Frame: Part B in-patient period (Day 1 and Day 2, and combined across Part B). ]
  • Bias of DPP CGM vs reference glucose by basal rate [ Time Frame: Part B in-patient period (Day 1 and Day 2, and combined across Part B). ]
  • Percent of DPP CGM sensor values meeting 20/20 agreement criteria vs YSI (excluding post-bolus affected periods) [ Time Frame: Part B in-patient period (Day 1 and Day 2, and combined across Part B). ]

Central Contacts and Locations

Central contacts

Karri Venn, BSc

647 274 4133karri.venn@clinsurge.ca

Eden Stein, B.Sc, M.Sc, MBA

416 688 0813eden.stein@clinsurge.ca

Locations

ClinSurge Research

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Contacts

Eden Stein, B.Sc, M.Sc, MBA

416 688 0813eden.stein@clinsurge.ca

Principal Investigator:

Ronnie Aronson, M.D.

More Information

Sponsor

ClinSurge Research

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Type 1 Diabetes Mellitus
  • Hybrid closed-loop system
  • Closed-loop insulin delivery
  • Automated insulin delivery
  • Continuous Glucose Monitoring
  • Insulin Pump
  • Type 1 Diabetes
  • Insulin Patch Pump
  • Dual-port Insulin Patch Pump

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ClinSurge Research on 2026-06-23.