T1D, T1DM, Type 1 Diabetes, Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes Mellitus, Hybrid closed-loop system, Closed-loop insulin delivery, Automated insulin delivery, Continuous Glucose Monitoring, Insulin Pump, Type 1 Diabetes, Insulin Patch Pump, Dual-port Insulin Patch Pump
Brief 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.
Detailed description
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.
Interventions
DEVICEDPP 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.
Sponsors
ClinSurge Research
McGill University Health Centre/Research Institute of the McGill University Health Centre
PharmaSens AG, Biel/Bienne Switzerland
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a two-part, sequential interventional study in which Part A is completed prior to the initiation of Part B. While participants from Part A may continue into Part B, participation in Part B is optional and Part B may enroll additional participants independently.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overnight percentage of time in glucose ranges (Dexcom G7) | 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. |
| Daytime percentage of time in glucose ranges (Dexcom G7) | 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. |
| Total daily insulin dose | 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. |
| Mean sensor glucose level | 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. |
Countries
Canada
Contacts
CONTACTKarri Venn, BSc
CONTACTEden Stein, B.Sc, M.Sc, MBA
Outcome results
None listed