Simultaneous Measurement and Responsive Treatment - Part 2

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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 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

Primary outcome measure(s)

• Maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose — 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 — 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 — 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 — 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) — 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 — 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 — 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 — 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) — 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).

Trial sites (1)

Other trials for the same condition