Type 1 DiabetesNCT04142229
Artificial Pancreas With Different Stress Assessments in the Outpatient Setting
A study testing iAPS and Sensor-Augmented Pump in people with Type 1 Diabetes, run by Sansum Diabetes Research Institute at 2 sites in United States.
Trial summary
This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- iAPS and Sensor-Augmented Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2019to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
- Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to include predictive or threshold low-glucose suspend or hybrid closed-loop with or without a Dexcom sensor.
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥18.0 years old
- HbA1c < 10.5%, as performed by point of care or central laboratory testing. HbA1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study and up to one month afterwards. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
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- Willingness to switch home pump to PLGS or full manual mode if using hybrid - Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
Who cannot join
- Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed.
- Have a blood pressure at screening outside the range of 160 mmHg systolic blood pressure and/or greater than 100 mmHg for diastolic blood pressure (if repeated measurements are within this range, the patient may be included in the study)
- Have coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
- Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk, to include:
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- Pregnancy, or planning pregnancy within 1 month of completing the clinical trial.
- Allergy or hypersensitivity to hydrocortisone, or any component of the formulation
- Presence of a known adrenal disorder
- Systemic fungal infections
- Active infection of any kind, or at risk of infection (susceptibility to infection) from known immunosuppression or underlying immunosuppressed condition
- Idiopathic thrombocytopenia purpura (ITP)
- Varicella
- Glaucoma or other chronic ocular condition that could be adversely affected by steroids (e.g., cataracts, increased ocular pressure from other causes, exophthalmos)
- Hypertension requiring treatment with one or more antihypertensive medications
- Congestive heart failure
- Current treatment for a seizure disorder
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write
- Known coronary artery disease
- Active gastroparesis
- Cystic fibrosis
- Uncontrolled thyroid disease (TSH undetectable or > 10 mIU/L)
- Known abuse of alcohol
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
- Current use of a beta blocker medication
- Laboratory results:
- HbA1c > 10.5%
- Abnormal liver or renal function (Transaminase >2 times the upper limit of normal, creatinine> 1.5 mg/dL)
- Labs drawn at screening visit or within three months prior to screening (for other purposes) will suffice for enrollment purposes
- Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
- Currently on long-term treatment using prednisone or other steroid
- If subject had been on short term treatment of prednisone, defer enrollment until underlying condition and prednisone treatment have resolved.
- Allergy to study drug, food or other study material.
- Clinically significant physical examination, laboratory test, or vital sign abnormality.
- Exposure to any investigational drug within 30 days.
- History of malignancy within the 5 years before screening (other than basal cell carcinoma).
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: A Randomized Crossover Comparison of Artificial Pancreas vs. Sensor Augmented Pump/Predictive Low Glucose Suspend With Different Stress Assessments in the Outpatient Setting for Patients With Type 1 Diabetes
This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will include different stress induction and assessments over a 4 week period.
Read the detailed description
Eligible participants will be randomly assigned to one of two treatment arms: 1) AID for two weeks and SAP/PLGS for two weeks , or 2) SAP/PLGS for two weeks and AID for two weeks. During the 4-week trial, subjects will wear the Empatica E4 wristband every day to record electrodermal activity, accelerometer and heartrate data. Subjects will also complete logbooks to record activity and stress. During each two-week period, subjects will come to the clinical center twice for stress induction tests in a medically supervised setting.
- Conditions
- Type 1 Diabetes
- Being tested
- iAPS, Sensor-Augmented Pump
- Keywords
- type 1 diabetes, automated insulin delivery, artificial pancreas, stress
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iAPSDevice
The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
Sensor-Augmented PumpOther
Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.
| Study group | Role | What they receive |
|---|---|---|
| Automated Insulin Delivery | Experimental | Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting, and come to the clinical center twice for supervised stress assessments. Receives: Device: iAPS |
| SAP/PLGS | Active comparator | Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting, and come to the clinical center twice for supervised stress assessments. Receives: Other: Sensor-Augmented Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target glucose range
Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system
Measured: 4 weeks
Secondary outcomes (16)
Change in glucose levels with stress induction
Change in glucose levels with stress induction sessions (mg/dL)
Measured: 4 weeks
Change in insulin requirements with stress induction
Change in insulin requirements with stress induction sessions (units of insulin)
Measured: 4 weeks
EDA stress detection
Analysis of EDA to verify stress detection and correlation to glucose changes, both during the stress sessions and in the outpatient setting
Measured: 4 weeks
Postprandial Time in Target Range
Percent time within the target range of 70-180 mg/dl postprandial within 5 hours following meals
Measured: 4 weeks
Glucose < 70 mg/dL
Percent time GGM glucose < 70 mg/dL
Measured: 4 weeks
Glucose < 54 mg/dL
Percent time GGM glucose < 54 mg/dL
Measured: 4 weeks
Glucose > 180 mg/dL
Percent time GGM glucose > 180 mg/dL
Measured: 4 weeks
Glucose > 250 mg/dL
Percent time GGM glucose > 250 mg/dL
Measured: 4 weeks
Serious adverse events (SAE)
The total number of serious adverse events during the clinical trial
Measured: 4 weeks
Serious adverse device events (SADE)
The total number of serious adverse events related to the study device use during the clinical trial
Measured: 4 weeks
Adverse device effects (ADE)
The total number of adverse device effects (ADE) during the clinical trial
Measured: 4 weeks
Unanticipated adverse device effects (UADE)
The total number of unanticipated adverse device effects (UADE) during the clinical trial
Measured: 4 weeks
Salivary cortisol assessment
Salivary cortisol assessment (nmol/l) during psychologic and physiologic stress induction
Measured: 4 weeks
Empatica device-based assessment of psychologic and physiologic stress
EDA Measurement of psychologic and physiologic stress from the Empatica E4 Watch
Measured: 4 weeks
Trier Social Stress Test (TSST)
Trier Social Stress Test (TSST) score at end of each test induction
Measured: 4 weeks
Socially evaluated cold-pressor test (SECPT)
Socially evaluated cold-pressor test (SECPT) score at end of each test induction
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start25 Oct 2019
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Harvard University
- Responsible party
- Sponsor
- Investigators
- Yogish Kudva, MBBS, Principal investigator, Mayo ClinicEyal Dassau, PhD, Principal investigator, Harvard UniversityJordan Pinsker, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142229
- Sponsor's protocol ID
- 19-006965
- Status last verified
- Nov 2020
- First submitted
- 25 Oct 2019
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pinsker JE, Deshpande S, McCrady-Spitzer S, Church MM, Kaur RJ, Perez J, Desjardins D, Piper M, Reid C, Doyle FJ 3rd, Kudva YC, Dassau E. Use of the Interoperable Artificial Pancreas System for Type 1 Diabetes Management During Psychological Stress. J Diabetes Sci Technol. 2021 Jan;15(1):184-185. doi: 10.1177/1932296820948566. Epub 2020 Aug 12. No abstract available.
PubMed 32783473Kaur RJ, Deshpande S, Pinsker JE, Gilliam WP, McCrady-Spitzer S, Zaniletti I, Desjardins D, Church MM, Doyle Iii FJ, Kremers WK, Dassau E, Kudva YC. Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges. Diabetes Technol Ther. 2022 May;24(5):338-349. doi: 10.1089/dia.2021.0436. Epub 2022 Apr 25.
PubMed 35049354
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Comparison of Artificial Pancreas vs. Sensor Augmented Pump/Predictive Low Glucose Suspend With Different Stress Assessments in the Outpatient Setting for Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04142229
- Acronym / sponsor ID
- 19-006965
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, automated insulin delivery, artificial pancreas, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Mayo Clinic, Harvard University
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will include different stress induction and assessments over a 4 week period.
Detailed description
Eligible participants will be randomly assigned to one of two treatment arms: 1) AID for two weeks and SAP/PLGS for two weeks , or 2) SAP/PLGS for two weeks and AID for two weeks. During the 4-week trial, subjects will wear the Empatica E4 wristband every day to record electrodermal activity, accelerometer and heartrate data. Subjects will also complete logbooks to record activity and stress. During each two-week period, subjects will come to the clinical center twice for stress induction tests in a medically supervised setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Automated Insulin Delivery | Experimental | Device: iAPSParticipants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting, and come to the clinical center twice for supervised stress assessments. |
| SAP/PLGS | Active comparator | Other: Sensor-Augmented PumpParticipants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting, and come to the clinical center twice for supervised stress assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
- Using an insulin pump for at least 3 months at the time of screening. Insulin pump use includes use of automated features, to include predictive or threshold low-glucose suspend or hybrid closed-loop with or without a Dexcom sensor.
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥18.0 years old
- HbA1c < 10.5%, as performed by point of care or central laboratory testing. HbA1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
Key exclusion criteria (38 listed)
- Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed.
- Have a blood pressure at screening outside the range of 160 mmHg systolic blood pressure and/or greater than 100 mmHg for diastolic blood pressure (if repeated measurements are within this range, the patient may be included in the study)
- Have coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
- Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iAPSThe AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices. | Device | Automated Insulin Delivery |
| Sensor-Augmented PumpSubjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor. | Other | SAP/PLGS |
Primary outcome
Time in target glucose range
Time frame: 4 weeks
Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system
16 secondary outcomes
Change in glucose levels with stress induction
Time frame: 4 weeks
Change in insulin requirements with stress induction
Time frame: 4 weeks
EDA stress detection
Time frame: 4 weeks
Postprandial Time in Target Range
Time frame: 4 weeks
Glucose < 70 mg/dL
Time frame: 4 weeks
Glucose < 54 mg/dL
Time frame: 4 weeks
Glucose > 180 mg/dL
Time frame: 4 weeks
Glucose > 250 mg/dL
Time frame: 4 weeks
Serious adverse events (SAE)
Time frame: 4 weeks
Serious adverse device events (SADE)
Time frame: 4 weeks
Adverse device effects (ADE)
Time frame: 4 weeks
Unanticipated adverse device effects (UADE)
Time frame: 4 weeks
Salivary cortisol assessment
Time frame: 4 weeks
Empatica device-based assessment of psychologic and physiologic stress
Time frame: 4 weeks
Trier Social Stress Test (TSST)
Time frame: 4 weeks
Socially evaluated cold-pressor test (SECPT)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Results publication: PubMed 32783473Pinsker JE, Deshpande S, McCrady-Spitzer S, Church MM, Kaur RJ, Perez J, Desjardins D, Piper M, Reid C, Doyle FJ 3rd, Kudva YC, Dassau E. Use of the Interoperable Artificial Pancreas System for Type 1 Diabetes Management During Psychological Stress. J Diabetes Sci Technol. 2021 Jan;15(1):184-185. doi: 10.1177/1932296820948566. Epub 2020 Aug 12. No abstract available.
- Derived from this study: PubMed 35049354Kaur RJ, Deshpande S, Pinsker JE, Gilliam WP, McCrady-Spitzer S, Zaniletti I, Desjardins D, Church MM, Doyle Iii FJ, Kremers WK, Dassau E, Kudva YC. Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges. Diabetes Technol Ther. 2022 May;24(5):338-349. doi: 10.1089/dia.2021.0436. Epub 2022 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yogish Kudva, MBBS principal investigator
Mayo Clinic
Eyal Dassau, PhD principal investigator
Harvard University
Jordan Pinsker, MD principal investigator
Sansum Diabetes Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iAPS and Sensor-Augmented Pump in people with Type 1 Diabetes, run by Sansum Diabetes Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in target glucose range (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.