Simultaneous Measurement and Responsive Treatment - Part 2
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinSurge Research
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
DPP System (Insulin Pump and Continuous Glucose Monitoring Platform)
DeviceParticipants 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Sensor Characterization and Automated Glycaemic ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.2
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.
Time frame
During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.3
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).
Time frame
During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.4
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.
Time frame
Part A in-patient period (Day 1 to Day 2), with primary comparison during the clamp and intensive monitoring period.Secondary outcomes
1
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.
Time frame
Part B in-patient period (Day 1 and Day 2 nights, and combined across Part B).2
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.
Time frame
Part B in-patient period (Day 1 and Day 2 daytime periods, and combined across Part B).3
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.
Time frame
Part B in-patient period (Day 1, Day 2, and combined across Part B).4
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.
Time frame
Part B in-patient period (Day 1, Day 2, and combined across Part B).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ClinSurge Research
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
PharmaSens AG, Biel/Bienne Switzerland
Collaborator
Source ClinicalTrials.gov