Testing DPP System (Insulin Pump and Continuous for type 1 diabetes mellitus
Official title: Simultaneous Measurement and Responsive Treatment - Part 2
Interventions
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.
Canadian Sites (1)
ClinSurge Research
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Total daily insulin dose (TDD) between 30 and 100 IU.
- +Totally daily insulin dose (TDD) between 30 and 100 IU.
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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.
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → (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 protocolProtocolThe detailed plan a study must follow.Read more → 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).
- +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.
- +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.
- +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.
- +Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
Exclusion
- −(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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- −Failure to comply with the study protocolProtocolThe detailed plan a study must follow.Read more → 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).
- −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.
- −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.
- −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.
- −Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
Early Phase 1Early Phase 1A very small, very early study of how the body handles a treatment.Read more → — the earliest human testing, in a very small group, to observe how the body handles it.
What is being given or done in this study: DPP System (Insulin Pump and Continuous Glucose Monitoring Platform).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Maximum post-bolus difference between DPP CGM sensor glucose and YSI plasma glucose — measured over 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 — measured over 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 — measured over 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 — measured over Part A in-patient period (Day 1 to Day 2), with primary comparison during the clamp and intensive monitoring period.
The study lists 5 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07655076 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: During Part A clamp period (Day 2; approximately 09:00-17:00), assessed after each bolus..
The study as a whole is currently expected to finish around 2026-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.