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Simultaneous Measurement and Responsive Treatment - Part 2 (SMART02)

2026年6月19日 更新者：ClinSurge Research

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M4G 3E8
        • 招聘中
        • ClinSurge Research
        • 接触：
        • 首席研究员：
          • Ronnie Aronson, M.D.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：不适用
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose
大体时间：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.
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
大体时间：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.
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
大体时间：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).
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
大体时间：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.
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)
大体时间：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.
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
大体时间：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.
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
大体时间：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.
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
大体时间：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.
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)
大体时间：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).
Part B in-patient period (Day 1 and Day 2, and combined across Part B).

次要结果测量

结果测量
措施说明
大体时间
Overnight percentage of time in glucose ranges (Dexcom G7)
大体时间：Part B in-patient period (Day 1 and Day 2 nights, and combined across Part B).
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.
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)
大体时间：Part B in-patient period (Day 1 and Day 2 daytime periods, and combined across Part B).
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.
Part B in-patient period (Day 1 and Day 2 daytime periods, and combined across Part B).
Total daily insulin dose
大体时间：Part B in-patient period (Day 1, Day 2, and combined across Part B).
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.
Part B in-patient period (Day 1, Day 2, and combined across Part B).
Mean sensor glucose level
大体时间：Part B in-patient period (Day 1, Day 2, and combined across Part B).
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.
Part B in-patient period (Day 1, Day 2, and combined across Part B).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ClinSurge Research

合作者

McGill University Health Centre/Research Institute of the McGill University Health Centre
PharmaSens AG, Biel/Bienne Switzerland

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月19日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月23日

上次提交的符合 QC 标准的更新

2026年6月19日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PTL-SMART02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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