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Simultaneous Measurement and Responsive Treatment - Part 2 (SMART02)

2026年6月12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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

40

段階

  • 初期フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M4G 3E8
        • 募集
        • ClinSurge Research
        • コンタクト：
        • 主任研究者：
          • Ronnie Aronson, M.D.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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 10 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：なし
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Overnight percentage of time in glucose ranges (Dexcom G7)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ClinSurge Research

協力者

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月19日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PTL-SMART02

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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