Pancreatic NeoplasmsPhase 3PANORAMANCT06346366
Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy
A Phase 3 study testing Bihormonal artificial pancreas (BIHAP) / closed loop in people with Pancreatic Neoplasms and Type 3c Diabetes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neoplasms, Type 3c Diabetes, Total Pancreatectomy
- What is being tested?
- Bihormonal artificial pancreas (BIHAP) / closed loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2023to 1 Apr 2024
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
- Age ≥18 years
- Insulin dependent diabetes after total pancreatectomy (patients who previously participated in APPEL 5+ are allowed to be included)
- At least three months after total pancreatectomy
- Patients using flash or continuous glucose sensor (Free Style Libre, Guardian or Medtronic) ,willing to scan this sensor at least three times per day during the control period and to remove this sensor during BIHAP treatment
- Undergoing treatment with CSII or subcutaneous insulin injections.
Who cannot join
- Known or suspected allergy to trial product(s) or related products;
- Suboptimal clinical condition, for instance due to active postoperative surgical complications, including skin condition prohibiting needle insertion;
- Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment;
- Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening for other clinical trial related purposes;
- Current treatment with chemotherapy or when used less than 3 months prior to screening;
- BMI > 35 kg/m2;
Show all 13Show fewer
- HbA1c > 97 mmol/ml (=11.0 %);
- Use of oral glucose-lowering medication;
- Limited ability to see, and to hear or feel alarms signals of the BIHAP;
- Use of acetaminophen (paracetamol) during the use of the BIHAP, as this may influence the sensor glucose measurements.
- Current pregnancy, breast feeding or planning to become pregnant during the trial or using ineffective birth control methods;
- Patients with a concomitant disease affecting metabolic control;
- Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy (PANORAMA): Randomized Controlled Crossover Trial
In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.
The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, [IQR 71.05%-82.61%] vs. 57.38% [IQR 52.38%-81.35%], p=0.03).
Read more
Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.
The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over.
Read the detailed description
Rationale:
Insulin dependent diabetes after total pancreatectomy (TP) is difficult to manage due to the complete absence of alfa and beta cells. In a recent pilot study in 10 patients after total pancreatectomy, treatment with a bihormonal closed loop system was safe and resulted in better glucose control compared to current open loop therapy.
Objective:
To assess the efficacy of a 3-month treatment with a bihormonal artificial pancreas (BIHAP) in patients after total pancreatectomy compared to current diabetes care.
Secondary objectives are to assess the safety of BIHAP treatment; quality of life during BIHAP treatment and additional efficacy parameters.
Study design:
PANORAMA is a randomized, cross-over trial performed in an outpatient setting comparing closed loop diabetes treatment with BIHAP to open loop with current diabetes care (i.e., insulin pump or pen therapy) in 40 adults after TP. Patients will be recruited from Dutch Pancreatic Cancer Group hospitals and randomized to a 3-month treatment period with the BIHAP (preceded by a 5-day training period) or a 3-month treatment with their current diabetes care. Hereafter, all 40 patients will cross over. Study population: This trial will comprise in total 40 adult patients with insulin dependent diabetes at least three months after total pancreatectomy.
Intervention: The intervention is 3 months closed loop control of blood glucose with the BIHAP. Patients complete a 5-day training period before the intervention period will start. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. The control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months. After a wash-out period of 3 months, all patients will crossover to the other study arm.
Main study parameters/endpoints:
The primary endpoint will be time (in %) spent in the normal glucose range (3.9 mmol/l - 10.0 mmol/l).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will have to wear the prototype with two subcutaneous sensors and infusion sets continuously. There are no major risks associated with this study. The most prominent risk is failure of the BIHAP to regulate the plasma glucose concentration properly, which can result in hypo- or hyperglycemia. This may be caused by failure of the algorithm, technical failure or due to incorrect glucose measurements. However, with multiple risk control measures the risk for the patients is minimized. The system comprises a controller, a separate safety processor, as well as multiple alerts that are built in the system.
The potential benefits for each patient include a significantly better glycemic control, as well as improved quality of life because the BIHAP system completely takes over the glucose regulation, thereby minimizing the burden of life with diabetes.
- Conditions
- Pancreatic Neoplasms, Type 3c Diabetes, Total Pancreatectomy
- Being tested
- Bihormonal artificial pancreas (BIHAP) / closed loop
- Keywords
- Bihormonal artificial pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bihormonal artificial pancreas (BIHAP) / closed loopDevice
Also called Current regular diabetes treatment / open loop
The investigational device is a dual-hormonal fully closed loop system (BIHAP; industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally controlling plasma glucose levels. This BIHAP contains of two pumps for subcutaneous infusion of either insulin (Humalog, 3 ml pre-fill cartridge, Eli Lilly) or glucagon (GlucaGen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) via an infusion set (Accu-Chek Insight Flex or AccuChek Flex Link, Roche), two subcutaneously placed glucose-sensors (Guardian, Medtronic) and an algorithm driving pump infusion rates based on the sensor input. Daily self-measurements of blood glucose (SMBGs; Accu-Chek Instant, Roche) are needed for calibration of the glucose sensors.
The BIHAP-system has to be worn continuously, except while showering.
| Study group | Role | What they receive |
|---|---|---|
| Open loop | Active comparator | The control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months. Receives: Device: Bihormonal artificial pancreas (BIHAP) / closed loop |
| Closed loop | Experimental | The intervention arm is 3 months closed loop control of blood glucose with the BIHAP. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. Patients complete a training period before the intervention period will start. Receives: Device: Bihormonal artificial pancreas (BIHAP) / closed loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Time spent in euglycemia (glucose value 3.9-10.0 mmol/l or 70-180mg/dL) during BIHAP treatment
Measured: During open and closed loop treatment (both 3 months)
Secondary outcomes (15)
Efficacy of open and closed loop system
Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;
- Day, night, and overall time spent in the following hypo-, and hyperglycemic ranges (percentage of time)
- Percentage of time spent in the following categories:
- Hypoglycemia level 1: <3.9 mmol/l;
- Hypoglycemia level 2: <3.0 mmol/l;
- Hyperglycemia level 1: >10mmol/l;
- Hyperglycemia level 2: >13.9mmol/l.
Measured: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;
- Glycemic, variability assessed by SD and CV (Coefficient of Variation)
Measured: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;
- Daily insulin and glucagon use (in IE)
Measured: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;
- Day, night and overall median sensor glucose concentration (mmol/l)
- Median sensor glucose concentrations (mmol/l)
- Mean HbA1c (mmol/ml)
Measured: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Additional metrics relating to glucose control will be compared between intervention and control period to provide more information about the efficacy of the BIHAP. This includes the following;
- Percentage of patients achieving HbA1c ≤ 53 mmol/mol at baseline and after each treatment period
Measured: During open and closed loop treatment (both 3 months)
Adverse events and device issues associated with closed loop system with BIHAP
Safety of glucose control with BIHAP treatment will be evaluated by assessing the incidence of (severe) adverse events and the incidence of device issues.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - WHO-5
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- World Health Organization-Five Well-Being Index (WHO-5) score; The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - EQ-5D-5L
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Health-related quality of life scores (EQ-5D-5L); Overall current health is scored on a scale from 0-100, whereby 100 is labelled as 'The best health you can imagine' and 0 as 'The worst health you can imagine.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - DTSQc andDTSQs
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Diabetes Treatment and Satisfaction Questionnaire status and change (DTSQ-s and DTSQ-c) scores; The DTSQ status (DTSQs) items are scored on a scale from 6 to 0 and DTSQ change (DTSQc) items are on a scale from 3 to -3. The scale total is computed by adding the six items 1, 4, 5, 6, 7 and 8 to produce the Treatment Satisfaction scale total, which has a minimum of zero and a maximum of 36 on the DTSQs and a minimum of -18 and a maximum of 18 on the DTSQc.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - PAID-20
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Problem Areas In Diabetes (PAID-20) score; PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. A score of 40 or above is indicative of severe emotional distress.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - HFS-II
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Hypoglycaemia Fear Survey-II (HFS-II) Worry subscale score; The HFS-II subscale scores and total score are sum scores of all or relevant subset of items ranging 0-60, 0-72, and 0-132 for the HFS-B, HFS-W, and HFS-II, respectively. Higher scores indicate higher fear of hypoglycemia.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - PSQI
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Pittsburg Sleep Quality Index score (PSQI); In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - INSPIRE
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Insulin delivery systems: perceptions, ideas, reflections and expectations (INSPIRE) scores; The five response options are scored as 4 = Strongly Agree, 3 = Agree, 2 = Neither Agree or Disagree, 1 = Disagree, and 0 = Strongly Disagree. All items are responded to on this same scale and there are no reverse-scored items. Multiply the mean score calculated in step two by 25. This score represents a scaled score from 0 to 100 and was done in order to provide similar scaling as other commonly used quality of life scales. This final score will range from 0 to 100. Higher scores indicate more positive appraisal of automated insulin dosing
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - Hypoglycaemia unawareness
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Hypoglycaemia unawareness (Gold-Clarke); Each question's response corresponds to "aware" (value 0) or "unaware" (value 1); scores are then summed. Scores of 0-2 are categorized as "aware", 4-7 as "unaware", and 3 as "indeterminant". The Gold questionnaire has only 1 question: "Do you know when your hypoglycemic episodes are commencing?" and is scored on a 7-point Likert scale. Scores of 1-2 are categorized as "Aware", 4-7 as "unaware", and 3 as "indeterminant".
Measured: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment
To assess the impact of novel treatment with BIHAP on quality of life. The following questionnaires will be used to assess and compare quality of life during BIHAP treatment and regular treatment. All questionnaires will be filled at baseline, the start and end of both treatment arms;
- Patient reported benefits and disadvantages of BIHAP treatment, including continuation of BIHAP treatment if this was possible
Measured: During open and closed loop treatment (both 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start25 Apr 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients are randomized to a 3-month treatment period with the bihormonal artificial pancreas (BIHAP) (preceded by a training period) or a 3-month treatment with their current diabetes care. Hereafter, all patients will cross over.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.G. Besselink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346366
- Sponsor's protocol ID
- NL.82557.018.22
- Acronym
- PANORAMA
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy (PANORAMA): Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06346366
- Acronym / sponsor ID
- PANORAMA / NL.82557.018.22
- Conditions
- Pancreatic Neoplasms, Type 3c Diabetes, Total Pancreatectomy
- Keywords
- Bihormonal artificial pancreas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 4 Apr 2024 (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.
In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.
The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, [IQR 71.05%-82.61%] vs. 57.38% [IQR 52.38%-81.35%], p=0.03).
Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.
The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over.
Detailed description
Rationale:
Insulin dependent diabetes after total pancreatectomy (TP) is difficult to manage due to the complete absence of alfa and beta cells. In a recent pilot study in 10 patients after total pancreatectomy, treatment with a bihormonal closed loop system was safe and resulted in better glucose control compared to current open loop therapy.
Objective:
To assess the efficacy of a 3-month treatment with a bihormonal artificial pancreas (BIHAP) in patients after total pancreatectomy compared to current diabetes care.
Secondary objectives are to assess the safety of BIHAP treatment; quality of life during BIHAP treatment and additional efficacy parameters.
Study design:
PANORAMA is a randomized, cross-over trial performed in an outpatient setting comparing closed loop diabetes treatment with BIHAP to open loop with current diabetes care (i.e., insulin pump or pen therapy) in 40 adults after TP. Patients will be recruited from Dutch Pancreatic Cancer Group hospitals and randomized to a 3-month treatment period with the BIHAP (preceded by a 5-day training period) or a 3-month treatment with their current diabetes care. Hereafter, all 40 patients will cross over. Study population: This trial will comprise in total 40 adult patients with insulin dependent diabetes at least three months after total pancreatectomy.
Intervention: The intervention is 3 months closed loop control of blood glucose with the BIHAP. Patients complete a 5-day training period before the intervention period will start. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. The control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months. After a wash-out period of 3 months, all patients will crossover to the other study arm.
Main study parameters/endpoints:
The primary endpoint will be time (in %) spent in the normal glucose range (3.9 mmol/l - 10.0 mmol/l).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will have to wear the prototype with two subcutaneous sensors and infusion sets continuously. There are no major risks associated with this study. The most prominent risk is failure of the BIHAP to regulate the plasma glucose concentration properly, which can result in hypo- or hyperglycemia. This may be caused by failure of the algorithm, technical failure or due to incorrect glucose measurements. However, with multiple risk control measures the risk for the patients is minimized. The system comprises a controller, a separate safety processor, as well as multiple alerts that are built in the system.
The potential benefits for each patient include a significantly better glycemic control, as well as improved quality of life because the BIHAP system completely takes over the glucose regulation, thereby minimizing the burden of life with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized to a 3-month treatment period with the bihormonal artificial pancreas (BIHAP) (preceded by a training period) or a 3-month treatment with their current diabetes care. Hereafter, all patients will cross over.
| Arm | Type | Receives |
|---|---|---|
| Open loop | Active comparator | Device: Bihormonal artificial pancreas (BIHAP) / closed loopThe control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months. |
| Closed loop | Experimental | Device: Bihormonal artificial pancreas (BIHAP) / closed loopThe intervention arm is 3 months closed loop control of blood glucose with the BIHAP. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. Patients complete a training period before the intervention period will start. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Age ≥18 years
- Insulin dependent diabetes after total pancreatectomy (patients who previously participated in APPEL 5+ are allowed to be included)
- At least three months after total pancreatectomy
- Patients using flash or continuous glucose sensor (Free Style Libre, Guardian or Medtronic) ,willing to scan this sensor at least three times per day during the control period and to remove this sensor during BIHAP treatment
Key exclusion criteria (13 listed)
- Known or suspected allergy to trial product(s) or related products;
- Suboptimal clinical condition, for instance due to active postoperative surgical complications, including skin condition prohibiting needle insertion;
- Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment;
- Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening for other clinical trial related purposes;
- Current treatment with chemotherapy or when used less than 3 months prior to screening;
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 |
|---|---|---|
| Bihormonal artificial pancreas (BIHAP) / closed loopAlso: Current regular diabetes treatment / open loopThe investigational device is a dual-hormonal fully closed loop system (BIHAP; industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally controlling plasma glucose levels. This BIHAP contains of two pumps for subcutaneous infusion of either insulin (Humalog, 3 ml pre-fill cartridge, Eli Lilly) or glucagon (GlucaGen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) via an infusion set (Accu-Chek Insight Flex or AccuChek Flex Link, Roche), two subcutaneously placed glucose-sensors (Guardian, Medtronic) and an algorithm driving pump infusion rates based on the sensor input. Daily self-measurements of blood glucose (SMBGs; Accu-Chek Instant, Roche) are needed for calibration of the glucose sensors. The BIHAP-system has to be worn continuously, except while showering. | Device | Closed loop, Open loop |
Primary outcome
Time in range
Time frame: During open and closed loop treatment (both 3 months)
Time spent in euglycemia (glucose value 3.9-10.0 mmol/l or 70-180mg/dL) during BIHAP treatment
15 secondary outcomes
Efficacy of open and closed loop system
Time frame: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time frame: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time frame: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time frame: During open and closed loop treatment (both 3 months)
Efficacy of open and closed loop system
Time frame: During open and closed loop treatment (both 3 months)
Adverse events and device issues associated with closed loop system with BIHAP
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - WHO-5
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - EQ-5D-5L
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - DTSQc andDTSQs
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - PAID-20
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - HFS-II
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - PSQI
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - INSPIRE
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - Hypoglycaemia unawareness
Time frame: During open and closed loop treatment (both 3 months)
Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment
Time frame: During open and closed loop treatment (both 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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 3 study testing Bihormonal artificial pancreas (BIHAP) / closed loop in people with Pancreatic Neoplasms and Type 3c Diabetes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time in range (time frame: During open and closed loop treatment (both 3 months)). 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 4 Apr 2024.