Diabetes Mellitus, Type 1Phase 2dasiglucagonNCT02971228
Feasibility Trial Testing the Bionic Pancreas With ZP4207
A Phase 2 study testing Insulin Lispro, ZP4207 (dasiglucagon) and Glucagon in people with Diabetes Mellitus, Type 1, run by Zealand Pharma at 1 site in United States.
Trial summary
The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin Lispro, ZP4207 (dasiglucagon) and Glucagon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 7 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with T1DM for at least 1 year, as defined by the American Diabetes Association
- Age ≥ 18 years
- Prescription medication regimen stable for >1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)
- Diabetes managed using an insulin pump for >=6 months
- Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the Investigator
Who cannot join
- Previous exposure to ZP4207 or adverse reaction to glucagon
- History of liver disease or current abnormal liver function tests (LFTs)
- Renal failure
- Anemia
- History of coronary artery disease or congestive heart failure (class III or IV)
- History of transient ischemic attack or stroke
Show all 13Show fewer
- Seizure disorder
- Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM
- Other endocrine disorders
- Use of oral anti-diabetic medications
- Electronically powered implants
- Hypertension (≥160/100 mm Hg despite treatment)
- Inadequate venous (vein) access as determined by trial nurse or physician at time of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207
The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus.
*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
Read the detailed description
This was a single-center, open-label, 2-part, randomized cross-over trial. The trial was to enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.
In Part 1, patients participated in two 1-day treatment arms in random order (iPhone-based BP using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon) according to a pre-generated randomization scheme. In Part 2, it was planned to enrol additional patients to participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and iLet using Lilly glucagon) according to a pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.
One day the BP will use glucagon analogue ZP4207 (dasiglucagon) and the other day the BP will use Lilly glucagon. Subjects will also receive insulin lispro through the BP on both days. The trial will be conducted at single center, the Massachusetts General Hospital Diabetes Center in Boston, MA.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin Lispro, ZP4207 (dasiglucagon), Glucagon, iPhone-based bionic pancreas, iLet-based bionic pancreas
- Keywords
- glucagon, Type 1 diabetes mellitus, Bionic Pancreas, diabetes, iLet, iPhone, Beta Bionics, Anti-hypoglycemia, Glucagon Analog
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin LisproDrug
Also called HumaLOG, HumaLOG Cartridge, HumaLOG KwikPen
Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon)Drug
Also called dasiglucagon
A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
GlucagonDrug
Also called Glucagon for injection (rDNA original)
A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreasDevice
An experimental device.
iLet-based bionic pancreasDevice
An experimental device.
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Lilly glucagon then ZP4207 | Experimental | In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. Receives: Drug: Insulin Lispro; Drug: ZP4207 (dasiglucagon); Drug: Glucagon; Device: iPhone-based bionic pancreas |
| Part 1, ZP4207 then Lilly Glucagon | Experimental | In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. Receives: Drug: Insulin Lispro; Drug: ZP4207 (dasiglucagon); Drug: Glucagon; Device: iPhone-based bionic pancreas |
| Part 2, Lilly glucagon then ZP4207 | Experimental | In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted. Receives: Drug: Insulin Lispro; Drug: ZP4207 (dasiglucagon); Drug: Glucagon; Device: iLet-based bionic pancreas |
| Part 2, ZP4207 then Lilly Glucagon | Experimental | In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted. Receives: Drug: Insulin Lispro; Drug: ZP4207 (dasiglucagon); Drug: Glucagon; Device: iLet-based bionic pancreas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters.
See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section.
Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.
Measured: Up to 50 days
Secondary outcomes (18)
Pain Measured on a Visual Analog Scale (VAS)
The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3.
Measured: 16 hours
Nausea Measured on a Visual Analog Scale (VAS)
The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period.
Measured: 16 hours
Glycemic Regulation
Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose<60mg/dL)
Measured: 16 hours
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Measured: 16 hours
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Measured: 16 hours
Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Measured: 16 hours
Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Measured: 16 hours
CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Measured: 16 hours
CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Measured: 16 hours
Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues
Technical faults in terms of calibration issues were listed by patient.
Measured: 16 hours
Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues
Technical faults related to connectivity issues were listed
Measured: 16 hours
Diabetes Treatment Satisfaction Questionnaire - Status
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
Diabetes Treatment Satisfaction Questionnaire - Change
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
T1-Diabetes Distress Scale
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
Problem Areas in Diabetes Survey
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
Hypoglycemia Fear Survey
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
Impact of Daily Diabetes Demands
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
Bionic Pancreas User Opinion Survey
This questionnaire was not assessed as per protocol amendment 7.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion24 May 2017
- Study completion7 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Beta Bionics, Inc.
- Responsible party
- Sponsor
- Investigators
- Steven J Russell, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971228
- Sponsor's protocol ID
- ZP4207-16051
- Acronym
- dasiglucagon
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2016
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207
- ClinicalTrials.gov ID
- NCT02971228
- Acronym / sponsor ID
- dasiglucagon / ZP4207-16051
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- glucagon, Type 1 diabetes mellitus, Bionic Pancreas, diabetes, iLet, iPhone, Beta Bionics, Anti-hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Beta Bionics, Inc.
- Study start
- Nov 2016
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus.
*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
Detailed description
This was a single-center, open-label, 2-part, randomized cross-over trial. The trial was to enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.
In Part 1, patients participated in two 1-day treatment arms in random order (iPhone-based BP using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon) according to a pre-generated randomization scheme. In Part 2, it was planned to enrol additional patients to participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and iLet using Lilly glucagon) according to a pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.
One day the BP will use glucagon analogue ZP4207 (dasiglucagon) and the other day the BP will use Lilly glucagon. Subjects will also receive insulin lispro through the BP on both days. The trial will be conducted at single center, the Massachusetts General Hospital Diabetes Center in Boston, MA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1, Lilly glucagon then ZP4207 | Experimental | Drug: Insulin Lispro, Drug: ZP4207 (dasiglucagon), Drug: Glucagon, Device: iPhone-based bionic pancreasIn Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. |
| Part 1, ZP4207 then Lilly Glucagon | Experimental | Drug: Insulin Lispro, Drug: ZP4207 (dasiglucagon), Drug: Glucagon, Device: iPhone-based bionic pancreasIn Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. |
| Part 2, Lilly glucagon then ZP4207 | Experimental | Drug: Insulin Lispro, Drug: ZP4207 (dasiglucagon), Drug: Glucagon, Device: iLet-based bionic pancreasIn Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted. |
| Part 2, ZP4207 then Lilly Glucagon | Experimental | Drug: Insulin Lispro, Drug: ZP4207 (dasiglucagon), Drug: Glucagon, Device: iLet-based bionic pancreasIn Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with T1DM for at least 1 year, as defined by the American Diabetes Association
- Age ≥ 18 years
- Prescription medication regimen stable for >1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)
- Diabetes managed using an insulin pump for >=6 months
- Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the Investigator
Key exclusion criteria (13 listed)
- Previous exposure to ZP4207 or adverse reaction to glucagon
- History of liver disease or current abnormal liver function tests (LFTs)
- Renal failure
- Anemia
- History of coronary artery disease or congestive heart failure (class III or IV)
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 |
|---|---|---|
| Insulin LisproAlso: HumaLOG, HumaLOG Cartridge, HumaLOG KwikPenUsed to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose. | Drug | Part 1, Lilly glucagon then ZP4207, Part 1, ZP4207 then Lilly Glucagon, Part 2, Lilly glucagon then ZP4207, Part 2, ZP4207 then Lilly Glucagon |
| ZP4207 (dasiglucagon)Also: dasiglucagonA glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm. | Drug | Part 1, Lilly glucagon then ZP4207, Part 1, ZP4207 then Lilly Glucagon, Part 2, Lilly glucagon then ZP4207, Part 2, ZP4207 then Lilly Glucagon |
| GlucagonAlso: Glucagon for injection (rDNA original)A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm. | Drug | Part 1, Lilly glucagon then ZP4207, Part 1, ZP4207 then Lilly Glucagon, Part 2, Lilly glucagon then ZP4207, Part 2, ZP4207 then Lilly Glucagon |
| iPhone-based bionic pancreasAn experimental device. | Device | Part 1, Lilly glucagon then ZP4207, Part 1, ZP4207 then Lilly Glucagon |
| iLet-based bionic pancreasAn experimental device. | Device | Part 2, Lilly glucagon then ZP4207, Part 2, ZP4207 then Lilly Glucagon |
Primary outcome
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Time frame: Up to 50 days
Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters. See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section. Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.
18 secondary outcomes
Pain Measured on a Visual Analog Scale (VAS)
Time frame: 16 hours
Nausea Measured on a Visual Analog Scale (VAS)
Time frame: 16 hours
Glycemic Regulation
Time frame: 16 hours
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Time frame: 16 hours
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
Time frame: 16 hours
Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data
Time frame: 16 hours
Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured
Time frame: 16 hours
CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM
Time frame: 16 hours
CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download
Time frame: 16 hours
Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues
Time frame: 16 hours
Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues
Time frame: 16 hours
Diabetes Treatment Satisfaction Questionnaire - Status
Time frame: Up to 3 months
Diabetes Treatment Satisfaction Questionnaire - Change
Time frame: Up to 3 months
T1-Diabetes Distress Scale
Time frame: Up to 3 months
Problem Areas in Diabetes Survey
Time frame: Up to 3 months
Hypoglycemia Fear Survey
Time frame: Up to 3 months
Impact of Daily Diabetes Demands
Time frame: Up to 3 months
Bionic Pancreas User Opinion Survey
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Steven J Russell, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin Lispro, ZP4207 (dasiglucagon) and Glucagon in people with Diabetes Mellitus, Type 1, run by Zealand Pharma 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 5 inclusion and 13 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 23 Mar 2021. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters (time frame: Up to 50 days). 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 23 Mar 2021.