Glucose, Low BloodPhase 1/2NCT03428295
Dose Safety Hybrid Closed Loop and Fully Automated Closed Loop Artificial Pancreas Device in CRC
A Phase 1/2 study testing Dose Safety AP system in people with Glucose, Low Blood and Glucose, High Blood, run by Dose Safety Inc. at 1 site in United States.
Trial summary
The objective of this study is to test two different operating modes of the latest version of the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version 2.3), in a population of subjects with type 1 diabetes (TID) in a hospital CRC setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glucose, Low Blood, Glucose, High Blood
- What is being tested?
- Dose Safety AP system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 31 Aug 2019
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have type 1 diabetes for greater than 1 year
- Have a hemoglobin A1c less than 9.0%
- Participants in the FACL arm must report that they engage in aerobic exercise at least 30 minutes three times weekly
- If participants in the FACL arm are age >35 OR duration of T1D >15 years OR history of T1D complications (proliferative retinopathy, nephropathy, peripheral vascular disease, autonomic neuropathy), participant must have EKG within normal limits obtained within last 6 months of study date
- Age 18-70
- Fluent and literate in English
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- Use of an insulin pump for ≥ 3 months
- Use of a CGM/sensor for ≥ 5 days/week for ≥3 months
- Must have a diabetes care provider
- Use of an effective birth control method for women who are sexually active and of childbearing potential
- Willing and able to give informed consent
Who cannot join
- History of ≥ 1 episode of severe hypoglycemia (defined as hypoglycemia leading to loss of consciousness, seizure, or requiring assistance) in the previous 6 months
- History of ≥ 1 episode of DKA in the previous 6 months
- History of cardiovascular disease, characterized by any of the following:
- Prolonged QT or arrhythmia
- History of myocardial infarction within the past 6 months
- History of ischemia on functional cardiac exam within the last year
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- History of left ventricular ejection fraction < 30%
- Uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg)
- Current use of a beta blocker
- Stage 3 or greater renal disease
- Untreated thyroid disease
- History of substance abuse
- Current or previous use of medications for control of a seizure disorder
- Enrolled in another clinical trial in which they received investigational drug in the last 12 weeks
- Inability to comply with protocol
- Pregnant or breast feeding
- Use of medications other than insulin to control glucose
- Chronic corticosteroid use
- Pre-existing medical conditions deemed by study investigator to interfere with the study or increase risks of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessments of Hybrid Closed Loop and Fully Automated Closed Loop Dose Safety Artificial Pancreas Device in Type 1 Diabetes in a Hospital Clinical Research Setting
The objective of this study is to test two different operating modes of the latest version of the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version 2.3), in a population of subjects with type 1 diabetes (TID) in a hospital CRC setting. The first mode is the Fully Automated Closed Loop (FACL) mode, in which all insulin delivery is directed by the controller and the second mode is the Hybrid Closed Loop (HCL) mode, in which insulin delivery is a hybrid between controller directed delivery and user directed insulin delivery. There will be two study arms: HCL and FACL. No comparisons will be made between the two arms.
Read the detailed description
3.1 Overview Two independent questions will be addressed in this study. For evaluation of the safety and efficacy of the hybrid closed loop (HCL), participants will use the hybrid closed loop during and after a standardized meal on the clinical research center. For evaluation of the safety and efficacy of the fully automated closed loop (FACL), participants will use the system for a 24 hour clinical research center stay incorporating meals and standardized exercise. Safety and efficacy will be evaluated by descriptive outcomes including number of completed studies and glycemic control.
3.2 Eligibility. Participants will be recruited from the Diabetes Registry at the Benaroya Research Institute. Eligibile participants may enroll in the HCL, the FACL, or both studies.
HCL Study visit, Day 1 (~7 hours total): The below times are approximate and may be adjusted to accommodate the CRC schedule. Prior to arrival at the CRC, participants will be asked to eat their normal breakfast and take their usual amount of insulin based on BG and carbohydrate content before 8am. Once at the CRC, participants will be able to drink water ad lib, but no food other than the prescribed meals can be eaten, unless hypoglycemia intervention is necessary. Participants will be required to check FSBG before the meal and calibrate if the FSBG value varies by >30% from CGM value.
FACL Study visit, Day 1 (~ 23 hours total): The below times are approximate and may be adjusted to accommodate the CRC schedule. Prior to arrival at the CRC, participants will be asked to eat their normal breakfast and take their usual amount of insulin based on BG and carbohydrate content before 8 am. Once arrived at the CRC, participants will be able to drink water, but no food other than the prescribed meals can be eaten, unless hypoglycemia intervention is necessary. Participants will be required to check FSBG before meals, at bedtime and at 0300. They will calibrate if the FSBG value varies by >30% from the CGM value. They will calibrate the CGM every 12 hours as recommended by Dexcom.
- Conditions
- Glucose, Low Blood, Glucose, High Blood
- Being tested
- Dose Safety AP system
- Keywords
- artificial pancreas, automated insulin delivery, hybrid closed loop, APDS, fully automated closed loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Safety AP systemDevice
Device will be used to automatically dose insulin
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Single Cohort in CRC | Experimental | This study is a single-arm, single-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. Receives: Device: Dose Safety AP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in hypoglycemic range
defined as <70 mg/dL
Measured: 36 hours
Percentage of time in severe hyperglycemic range
defined as >/=250 mg/dL
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start22 Jun 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Why it stopped: Further software development is required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose, Low BloodStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental: Single Cohort in CRC This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. Intervention: Device: Dose Safety Artificial Pancreas (AP) System
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dose Safety Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Benaroya Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428295
- Sponsor's protocol ID
- APS4
- Other IDs
- 2R44DK104317-03
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments of Hybrid Closed Loop and Fully Automated Closed Loop Dose Safety Artificial Pancreas Device in Type 1 Diabetes in a Hospital Clinical Research Setting
- ClinicalTrials.gov ID
- NCT03428295
- Acronym / sponsor ID
- APS4
- Conditions
- Glucose, Low Blood, Glucose, High Blood
- Keywords
- artificial pancreas, automated insulin delivery, hybrid closed loop, APDS, fully automated closed loop
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Further software development is required.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dose Safety Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Benaroya Research Institute
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 9 Feb 2018 (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.
The objective of this study is to test two different operating modes of the latest version of the Dose Safety artificial pancreas system (APS), the Dose Safety Controller (DSC version 2.3), in a population of subjects with type 1 diabetes (TID) in a hospital CRC setting. The first mode is the Fully Automated Closed Loop (FACL) mode, in which all insulin delivery is directed by the controller and the second mode is the Hybrid Closed Loop (HCL) mode, in which insulin delivery is a hybrid between controller directed delivery and user directed insulin delivery. There will be two study arms: HCL and FACL. No comparisons will be made between the two arms.
Detailed description
3.1 Overview Two independent questions will be addressed in this study. For evaluation of the safety and efficacy of the hybrid closed loop (HCL), participants will use the hybrid closed loop during and after a standardized meal on the clinical research center. For evaluation of the safety and efficacy of the fully automated closed loop (FACL), participants will use the system for a 24 hour clinical research center stay incorporating meals and standardized exercise. Safety and efficacy will be evaluated by descriptive outcomes including number of completed studies and glycemic control.
3.2 Eligibility. Participants will be recruited from the Diabetes Registry at the Benaroya Research Institute. Eligibile participants may enroll in the HCL, the FACL, or both studies.
HCL Study visit, Day 1 (~7 hours total): The below times are approximate and may be adjusted to accommodate the CRC schedule. Prior to arrival at the CRC, participants will be asked to eat their normal breakfast and take their usual amount of insulin based on BG and carbohydrate content before 8am. Once at the CRC, participants will be able to drink water ad lib, but no food other than the prescribed meals can be eaten, unless hypoglycemia intervention is necessary. Participants will be required to check FSBG before the meal and calibrate if the FSBG value varies by >30% from CGM value.
FACL Study visit, Day 1 (~ 23 hours total): The below times are approximate and may be adjusted to accommodate the CRC schedule. Prior to arrival at the CRC, participants will be asked to eat their normal breakfast and take their usual amount of insulin based on BG and carbohydrate content before 8 am. Once arrived at the CRC, participants will be able to drink water, but no food other than the prescribed meals can be eaten, unless hypoglycemia intervention is necessary. Participants will be required to check FSBG before meals, at bedtime and at 0300. They will calibrate if the FSBG value varies by >30% from the CGM value. They will calibrate the CGM every 12 hours as recommended by Dexcom.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental: Single Cohort in CRC This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. Intervention: Device: Dose Safety Artificial Pancreas (AP) System
| Arm | Type | Receives |
|---|---|---|
| Experimental: Single Cohort in CRC | Experimental | Device: Dose Safety AP systemThis study is a single-arm, single-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have type 1 diabetes for greater than 1 year
- Have a hemoglobin A1c less than 9.0%
- Participants in the FACL arm must report that they engage in aerobic exercise at least 30 minutes three times weekly
- If participants in the FACL arm are age >35 OR duration of T1D >15 years OR history of T1D complications (proliferative retinopathy, nephropathy, peripheral vascular disease, autonomic neuropathy), participant must have EKG within normal limits obtained within last 6 months of study date
- Age 18-70
Key exclusion criteria (19 listed)
- History of ≥ 1 episode of severe hypoglycemia (defined as hypoglycemia leading to loss of consciousness, seizure, or requiring assistance) in the previous 6 months
- History of ≥ 1 episode of DKA in the previous 6 months
- History of cardiovascular disease, characterized by any of the following:
- Uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg)
- Current use of a beta blocker
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 |
|---|---|---|
| Dose Safety AP systemDevice will be used to automatically dose insulin | Device | Experimental: Single Cohort in CRC |
Primary outcome
Percentage of time in hypoglycemic range
Time frame: 36 hours
defined as <70 mg/dL
Percentage of time in severe hyperglycemic range
Time frame: 36 hours
defined as >/=250 mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dose Safety AP system in people with Glucose, Low Blood and Glucose, High Blood, run by Dose Safety Inc. at 1 site 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 11 inclusion and 19 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: paused, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Percentage of time in hypoglycemic range (time frame: 36 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2019.