Simultaneous Measurement and Responsive Treatment - Part 2

Sponsor
ClinSurge Research
Study ID
NCT07655076
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
May 19, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

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.

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. ]

Central Contacts

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