Simultaneous Measurement and Responsive Treatment - Part 2

NCT07655076 | Recruiting Early Phase 1

• 1 other identifier: PTL-SMART02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (9)

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

  Highest (maximum) difference between DPP integrated CGM sensor glucose and reference YSI plasma glucose concentration following each predefined insulin bolus delivered by the two DPP systems assigned to bolus delivery.

  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 from each predefined insulin bolus delivery to the time of the highest (maximum) difference between DPP integrated CGM sensor glucose and reference YSI plasma glucose concentration.

  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 from each predefined insulin bolus delivery until the DPP integrated CGM sensor signal is considered fully recovered following the transient post-bolus effect (as defined in the study analysis plan/protocol recovery criteria).

  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

  Percent of DPP integrated CGM sensor values meeting 20/20 agreement criteria compared with (a) reference YSI plasma glucose and (b) Dexcom G7 interstitial glucose. 20/20 is defined as within ±20% of the reference value when reference glucose is ≥100 mg/dL (5.5 mmol/L) and within ±20 mg/dL (1.1 mmol/L) when reference glucose is \<100 mg/dL (5.5 mmol/L). Reported including and excluding periods affected after bolus infusion, between bolus insulin deliveries, and during basal insulin deliveries.

  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)

  Percentage of time sensor glucose levels (Dexcom G7) are in each range: 3.9-7.8 mmol/L, 3.9-10.0 mmol/L, \<3.9 mmol/L, \<3.0 mmol/L, \>7.8 mmol/L, \>10.0 mmol/L, \>13.9 mmol/L Calculated for Day 1 and Day 2 separately and for the entire Part B intervention combined.

  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

  Mean absolute relative difference (MARD) of DPP integrated CGM values compared with (a) reference YSI plasma glucose and (b) Dexcom G7 interstitial glucose, expressed as a percentage. Calculated for Day 1, Day 2, and entire Part B combined.

  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

  Mean absolute deviation of DPP integrated CGM values compared with (a) reference YSI plasma glucose and (b) Dexcom G7 interstitial glucose, expressed in mmol/L, summarized for each basal rate.

  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

  Bias (DPP CGM minus reference) in mmol/L between DPP integrated CGM values and (a) reference YSI plasma glucose and (b) Dexcom G7 interstitial glucose, summarized for each basal rate.

  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)

  Percent of DPP integrated CGM sensor values meeting 20/20 agreement criteria compared with reference YSI plasma glucose, excluding times when the sensor is affected after bolus infusion. 20/20 is defined as within ±20% of the reference value when reference glucose is ≥100 mg/dL (5.5 mmol/L) and within ±20 mg/dL (1.1 mmol/L) when reference glucose is \<100 mg/dL (5.5 mmol/L).

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

Secondary Outcomes (4)

• Overnight percentage of time in glucose ranges (Dexcom G7)

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

• Daytime percentage of time in glucose ranges (Dexcom G7)

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

• Total daily insulin dose

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

• Mean sensor glucose level

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

Study Arms (1)

Sensor Characterization and Automated Glycaemic Control

EXPERIMENTAL

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.

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

Interventions

DPP System (Insulin Pump and Continuous Glucose Monitoring Platform) DEVICE

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.

Sensor Characterization and Automated Glycaemic Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 10 30 and 100 IU.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ClinSurge Research: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• PharmaSens AG, Biel/Bienne Switzerland: collaborator

Study Sites (1)

ClinSurge Research

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Related Publications (6)

• Cunningham H, Apostolopoulos J, Ngan J, Jones H, Barnard-Kelly K, Brown K, Dutt-Ballerstadt R, Flint S, Kong YW, Netzer E, Obeyesekere V, Reid S, Wu HP, Seidl T, O'Neal D. Feasibility study of a combined insulin-delivery and glucose sensor system worn over 7 days in persons with type 1 diabetes. Diabetes Obes Metab. 2026 Feb;28(2):1403-1410. doi: 10.1111/dom.70331. Epub 2025 Nov 25.

  PMID: 41290544 BACKGROUND

• Sperling MA, Laffel LM. Current Management of Glycemia in Children with Type 1 Diabetes Mellitus. N Engl J Med. 2022 Mar 24;386(12):1155-1164. doi: 10.1056/NEJMcp2112175. No abstract available.

  PMID: 35320645 BACKGROUND

• Bonato L, Taleb N, Gingras V, Messier V, Gobeil F, Menard J, Ardilouze JL, Rabasa-Lhoret R. Duration of Catheter Use in Patients with Diabetes Using Continuous Subcutaneous Insulin Infusion: A Review. Diabetes Technol Ther. 2018 Jul;20(7):506-515. doi: 10.1089/dia.2018.0110.

  PMID: 29958025 BACKGROUND

• Schoemaker M, Martensson A, Mader JK, Norgaard K, Freckmann G, Benhamou PY, Diem P, Heinemann L. Combining Glucose Monitoring and Insulin Infusion in an Integrated Device: A Narrative Review of Challenges and Proposed Solutions. J Diabetes Sci Technol. 2025 Mar;19(2):441-451. doi: 10.1177/19322968231203237. Epub 2023 Oct 5.

  PMID: 37798963 BACKGROUND

• Sherr JL, Heinemann L, Fleming GA, Bergenstal RM, Bruttomesso D, Hanaire H, Holl RW, Petrie JR, Peters AL, Evans M. Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetologia. 2023 Jan;66(1):3-22. doi: 10.1007/s00125-022-05744-z. Epub 2022 Oct 6.

  PMID: 36198829 BACKGROUND

• Berg AK, Norgaard K, Thyssen JP, Zachariae C, Hommel E, Rytter K, Svensson J. Skin Problems Associated with Insulin Pumps and Sensors in Adults with Type 1 Diabetes: A Cross-Sectional Study. Diabetes Technol Ther. 2018 Jul;20(7):475-482. doi: 10.1089/dia.2018.0088. Epub 2018 Jun 12.

  PMID: 29893593 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Karri Venn, BSc

CONTACT

647 274 4133; karri.venn@clinsurge.ca

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

CONTACT

416 688 0813; eden.stein@clinsurge.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a two-part, sequential interventional study in which Part A is completed prior to the initiation of Part B. While participants from Part A may continue into Part B, participation in Part B is optional and Part B may enroll additional participants independently.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 17, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)