Type 1 Diabetes MellitusEarly Phase 1SMART02NCT07655076
Simultaneous Measurement and Responsive Treatment - Part 2
A Early Phase 1 study testing DPP System (Insulin Pump and Continuous Glucose Monitoring Platform) in people with Type 1 Diabetes Mellitus and T1D, run by ClinSurge Research at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, T1D, Type 1 Diabetes
- What is being tested?
- DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 May 2026to 1 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
ClinSurge Research
Toronto, Ontario, M4G 3E8
Eden Stein, B.Sc, M.Sc, MBA, 416 688 0813, eden.stein@clinsurge.ca
Ronnie Aronson, M.D.
About this study
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.
Read more
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.
Read the detailed description
Current insulin pump and continuous glucose monitoring systems have improved glucose management for people with type 1 diabetes but typically require multiple devices worn at different body sites. This increases treatment burden and may contribute to device-related complications, including skin irritation, site failures, and challenges with coordination between devices. Integrating insulin delivery and glucose sensing into a single system may reduce these burdens and improve usability, but placing insulin infusion and glucose sensing close together may affect CGM accuracy.
This prospective, single-arm, early feasibility study is designed to evaluate an investigational Dual Port Pump (DPP) System, which integrates an insulin infusion patch pump with a CGM sensor positioned near the insulin delivery site. The objectives of the study are to characterize the effects of insulin bolus and basal infusion on CGM sensor readings, assess glucose sensing accuracy, and collect data to support development and optimization of a sensor recovery monitoring algorithm. In Part B, the study also evaluates the feasibility and performance of an automated glycaemic control algorithm used with the integrated system.
The study is conducted in two sequential in-patient parts and enrolls adults with type 1 diabetes.
Part A (Sensor Characterization) consists of a 1.5-day in-patient admission during which participants will wear three DPP systems simultaneously. One system will deliver varying basal insulin rates, while the other two systems will deliver predefined insulin boluses. Glucose levels will be intensively monitored using reference plasma glucose measurements obtained with a Yellow Springs Instruments (YSI) glucose analyzer, along with data from a commercially available CGM. Data from the integrated CGM sensor will not be used for therapy decisions in Part A.
Part B (Automated Glycaemic Control Feasibility) consists of a 2.5-day in-patient admission during which participants will wear one DPP system. CGM values from the integrated sensor will be manually entered by trained study staff into an automated glycaemic control algorithm at regular intervals. Insulin dose recommendations generated by the algorithm will be manually applied using the pump application. Participants will consume standardized meals and complete standardized exercise sessions to evaluate glucose control under controlled conditions.
Throughout both parts of the study, glucose levels will be closely monitored, and predefined procedures are in place for the treatment of hypoglycemia and hyperglycemia. Safety data and device performance data collected in this study will be used to inform further development of an integrated insulin delivery and glucose sensing system and to support future clinical studies.
- Conditions
- Type 1 Diabetes Mellitus, T1D, Type 1 Diabetes, T1DM
- Being tested
- DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DPP System (Insulin Pump and Continuous Glucose Monitoring Platform) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Percentage of overnight time (23:00-08:00) during which sensor glucose levels measured by the Dexcom G7 are within the following ranges: 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; and >13.9 mmol/L. Calculated for Day 1 and Day 2 separately and for the entire Part B intervention combined.
Measured: 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)
Percentage of daytime time (08:00-23:00) during which sensor glucose levels measured by the Dexcom G7 are within the following ranges: 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; and >13.9 mmol/L. Calculated for Day 1 and Day 2 separately and for the entire Part B intervention combined.
Measured: Part B in-patient period (Day 1 and Day 2 daytime periods, and combined across Part B).
Total daily insulin dose
Total daily insulin dose (TDD), expressed in international units (IU), calculated for Day 1 and Day 2 separately and for the entire Part B intervention combined.
Measured: Part B in-patient period (Day 1, Day 2, and combined across Part B).
Mean sensor glucose level
Mean sensor glucose level measured by the Dexcom continuous glucose monitoring system, calculated for Day 1 and Day 2 separately and for the entire Part B intervention combined.
Measured: Part B in-patient period (Day 1, Day 2, and combined across Part B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start19 May 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinSurge Research
- Sponsor type
- Research network
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, PharmaSens AG, Biel/Bienne Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655076
- Sponsor's protocol ID
- PTL-SMART02
- Acronym
- SMART02
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41290544Sperling 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.
PubMed 35320645Bonato 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.
PubMed 29958025Schoemaker 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.
PubMed 37798963Sherr 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.
PubMed 36198829Berg 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.
PubMed 29893593
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Measurement and Responsive Treatment - Part 2
- ClinicalTrials.gov ID
- NCT07655076
- Acronym / sponsor ID
- SMART02 / PTL-SMART02
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ClinSurge ResearchResearch network
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, PharmaSens AG, Biel/Bienne Switzerland
- Study start
- 19 May 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current insulin pump and continuous glucose monitoring systems have improved glucose management for people with type 1 diabetes but typically require multiple devices worn at different body sites. This increases treatment burden and may contribute to device-related complications, including skin irritation, site failures, and challenges with coordination between devices. Integrating insulin delivery and glucose sensing into a single system may reduce these burdens and improve usability, but placing insulin infusion and glucose sensing close together may affect CGM accuracy.
This prospective, single-arm, early feasibility study is designed to evaluate an investigational Dual Port Pump (DPP) System, which integrates an insulin infusion patch pump with a CGM sensor positioned near the insulin delivery site. The objectives of the study are to characterize the effects of insulin bolus and basal infusion on CGM sensor readings, assess glucose sensing accuracy, and collect data to support development and optimization of a sensor recovery monitoring algorithm. In Part B, the study also evaluates the feasibility and performance of an automated glycaemic control algorithm used with the integrated system.
The study is conducted in two sequential in-patient parts and enrolls adults with type 1 diabetes.
Part A (Sensor Characterization) consists of a 1.5-day in-patient admission during which participants will wear three DPP systems simultaneously. One system will deliver varying basal insulin rates, while the other two systems will deliver predefined insulin boluses. Glucose levels will be intensively monitored using reference plasma glucose measurements obtained with a Yellow Springs Instruments (YSI) glucose analyzer, along with data from a commercially available CGM. Data from the integrated CGM sensor will not be used for therapy decisions in Part A.
Part B (Automated Glycaemic Control Feasibility) consists of a 2.5-day in-patient admission during which participants will wear one DPP system. CGM values from the integrated sensor will be manually entered by trained study staff into an automated glycaemic control algorithm at regular intervals. Insulin dose recommendations generated by the algorithm will be manually applied using the pump application. Participants will consume standardized meals and complete standardized exercise sessions to evaluate glucose control under controlled conditions.
Throughout both parts of the study, glucose levels will be closely monitored, and predefined procedures are in place for the treatment of hypoglycemia and hyperglycemia. Safety data and device performance data collected in this study will be used to inform further development of an integrated insulin delivery and glucose sensing system and to support future clinical studies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sensor Characterization and Automated Glycaemic Control | Experimental | Device: DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sensor Characterization and Automated Glycaemic Control |
Primary outcome
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.
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.
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 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.
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.
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).
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 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.
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).
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.
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 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.
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).
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.
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).
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.
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).
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).
4 secondary outcomes
Overnight percentage of time in glucose ranges (Dexcom G7)
Time frame: 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)
Time frame: Part B in-patient period (Day 1 and Day 2 daytime periods, and combined across Part B).
Total daily insulin dose
Time frame: Part B in-patient period (Day 1, Day 2, and combined across Part B).
Mean sensor glucose level
Time frame: Part B in-patient period (Day 1, Day 2, and combined across Part B).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 41290544Cunningham 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.
- Background: PubMed 35320645Sperling 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.
- Background: PubMed 29958025Bonato 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.
- Background: PubMed 37798963Schoemaker 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.
- Background: PubMed 36198829Sherr 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.
- Background: PubMed 29893593Berg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DPP System (Insulin Pump and Continuous Glucose Monitoring Platform) in people with Type 1 Diabetes Mellitus and T1D, run by ClinSurge Research at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karri Venn, BSc (647 274 4133, karri.venn@clinsurge.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07655076, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.