Diabetes Mellitus, Type 1PAPAYA 1NCT05543850
Portable Artificial Pancreas Applied for Youth and Adolescents
A study of Diabetes Mellitus, Type 1, run by Inreda Diabetic B.V. at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Oct 2022to 19 May 2023
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with type 1 diabetes mellitus
- Twelve to eighteen years old;
- Treated with insulin therapy for at least 6 months;
- Willing and able to sign informed consent or to assent to study participation.
Who cannot join
- Impaired awareness of hypoglycaemia (score ≥ 4) according to Gold and/or Clarke questionnaire[6,7];
- BMI ≥ 35 kg/m2;
- Pregnancy and/or breastfeeding;
- HbA1c > 97 mmol/mol (11.0%);
- Use of acetaminophen (paracetamol) during the open loop or closed-loop period,as this may influence the sensor glucose measurements;
- Limited ability to see, hear or feel the alarm signals of the closed-loop system;
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- Unwillingness to act in response to the alarm signals;
- Living alone during the night during the closed-loop period (the patient may ask someone to stay over temporarily);
- Expected poor internet connectivity regarding 24/7 tele monitoring;
- Any condition that the local investigator feels would interfere with trial participation or evaluation of the results.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared.
This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.
Read the detailed description
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In previous studies, we tested the performance and safety of this bi-hormonal closed-loop system in an outpatient setting in patients with type 1 diabetes mellitus (T1DM) for a duration up to 2 weeks, leading to CE-marking of the system. The device is currently intended for insulin-dependent adult patients with diabetes. However, there is great need to improve glycaemic control in youth and adolescents with diabetes.
Objective of the study:
The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: to assess the safety of the closed-loop system; to determine the time that the closed-loop algorithm is active; and to assess expectations and treatment satisfaction of the closed-loop system.
Study design:
This study is a monocenter randomized cross-over trial.
Study population:
The study population will comprise 20 patients with T1DM, between 12 and 18 years old, not having impaired awareness of hypoglycaemia, and who are treated with insulin therapy for at least 6 months. Patients receiving treatment with multiple daily injections (MDI) or continuous subcutaneous insulin injections (CSII), and in addition glucose monitoring using self-monitored blood glucose (SMBG), flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) are included into the study.
Intervention:
The intervention includes 2 weeks of closed-loop control with the artificial pancreas (AP) of Inreda Diabetic. The device uses 2 subcutaneous glucose sensors, 2 subcutaneous infusion sets, and incorporates 2 pumps and a reactive closed-loop algorithm. During 4-6 days before the intervention the patients receive training on the use of the closed-loop system and will start using the device under close supervision. The control arm (open loop treatment) consists of the patient's standard therapy at home for 2 weeks.
Main study parameters/endpoints:
Main study parameter is the percentage of time spent in the target range (3.9-10.0 mmol/L), which will be compared between the open and closed-loop periods for each patient.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Bi-hormonal closed-loop control, Open-loop control
- 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.
Bi-hormonal closed-loop controlDevice
Also called Artificial Pancreas (AP), bi-hormonal AP system, AP5
During bi-hormonal closed-loop control insulin and glucagon are administered to the developed closed-loop algorithm. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the closed loop period.
Open-loop controlDevice
During open-loop control the patients will use their usual diabetes therapy. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the open loop period.
| Study group | Role | What they receive |
|---|---|---|
| Open loop control | Active comparator | In this arm, the patients will use their usual diabetes therapy. Additionally, patients will wear a blinded DexcomG6 for data collection during the open loop period. Receives: Device: Open-loop control |
| Bi-hormonal closed-loop control | Experimental | In this arm, treatment consists of the bi-hormonal closed-loop system. A short acting insulin analogue (Humalog, 3 ml pre-filled cartridge, Eli Lilly) and glucagon (Glucagen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) will be administered according to the closed-loop algorithm. Additionally, patients will wear a blinded DexcomG6 for data collection during the closed loop period. Receives: Device: Bi-hormonal closed-loop control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
The proportion of time spent in the range of 3.9-10.0 mmol/L in %
Measured: 2 weeks
Secondary outcomes (22)
Time in hypoglycemia 1
The proportion of time spent in hypoglycemia (<3.9 mmol/L) in %
Measured: 2 weeks
Time in hypoglycemia 2
The proportion of time spent in hypoglycemia (<3.0 mmol/L) in %
Measured: 2 weeks
Time in hyperglycemia 1
The proportion of time spent in hyperglycemia (>10.0 mmol/L) in %
Measured: 2 weeks
Time in hyperglycemia 2
The proportion of time spent in hyperglycemia (>13.9 mmol/L) in %
Measured: 2 weeks
Mean glucose concentration
Mean glucose concentration in mmol/L
Measured: 2 weeks
Median glucose concentration
Median glucose concentration in mmol/L
Measured: 2 weeks
Glycemic variability - Coefficient of variation
Coefficient of variation (standard deviation divided by the mean) in %
Measured: 2 weeks
Glycemic variability - Interquartile range
Interquartile range in mmol/L
Measured: 2 weeks
Mean glucose concentration during the day
Mean glucose concentration in mmol/L during the day (6AM - 12PM)
Measured: 2 weeks
Mean glucose concentration during the night (12PM - 6AM)
Mean glucose concentration in mmol/L during the night (12PM - 6AM)
Measured: 2 weeks
Median glucose concentration during the day (6AM - 12PM)
Median glucose concentration in mmol/L during the day (6AM - 12PM)
Measured: 2 weeks
Median glucose concentration during the night (12PM - 6AM)
Median glucose concentration in mmol/L during the night (12PM - 6AM)
Measured: 2 weeks
Time spent in hypoglycemia during the night
Time spent in hypoglycemia (<3.9 mmol/L) during the night (12PM - 6AM) in %
Measured: 2 weeks
Time spent in hyperglycemia during the night
Time spent in hyperglycemia (>10.0 mmol/L) during the night (12PM - 6AM) in %
Measured: 2 weeks
Time spent in euglycemia during the night
Time spent in euglycemia (<3.9 mmol/L and <10 mmol/L) during the night (12PM - 6AM) in %
Measured: 2 weeks
Time spent in hypoglycemia during the day
Time spent in hypoglycemia (<3.9 mmol/L) during the day (6AM - 12PM) in %
Measured: 2 weeks
Time spent in hyperglycemia during the day
Time spent in hyperglycemia (>10.0 mmol/L) during the day (6AM - 12PM) in %
Measured: 2 weeks
Time spent in euglycemia during the day
Time spent in euglycemia (<3.9 mmol/L and <10 mmol/L) during the day (6AM - 12PM) in %
Measured: 2 weeks
Algorithm active time
Time that the closed-loop algorithm is active in %
Measured: 2 weeks
Expectations
INSPIRE questionnaire (only for closed loop)
Measured: 2 weeks
Trust
TAS questionnaire (only for closed loop)
Measured: 2 weeks
Satisfaction
DTSQ questionnaire (for open loop and closed loop)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start28 Oct 2022
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a monocenter, randomized cross-over trial. The total duration of the study will be three months: two weeks open loop control and 4-6 training days followed by a two-week closed-loop period, or vice versa, with at least 2 weeks in between.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inreda Diabetic B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stichting Robopump, Rijnstate ziekenhuis, Kinder Diabetes Centrum Nijmegen
- Responsible party
- Sponsor
- Investigators
- Arianne Bon, MD, PhD, Principal investigator, Rijnstate ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543850
- Sponsor's protocol ID
- NL79829.000.22
- Acronym
- PAPAYA 1
- Status last verified
- Aug 2023
- First submitted
- 13 Sep 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Artificial Pancreas Applied for Youth and Adolescents
- ClinicalTrials.gov ID
- NCT05543850
- Acronym / sponsor ID
- PAPAYA 1 / NL79829.000.22
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inreda Diabetic B.V.Industry (pharma, biotech, devices)
- Collaborators
- Stichting Robopump, Rijnstate ziekenhuis, Kinder Diabetes Centrum Nijmegen
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 16 Sep 2022 (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 purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared.
This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.
Detailed description
Background of the study:
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In previous studies, we tested the performance and safety of this bi-hormonal closed-loop system in an outpatient setting in patients with type 1 diabetes mellitus (T1DM) for a duration up to 2 weeks, leading to CE-marking of the system. The device is currently intended for insulin-dependent adult patients with diabetes. However, there is great need to improve glycaemic control in youth and adolescents with diabetes.
Objective of the study:
The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: to assess the safety of the closed-loop system; to determine the time that the closed-loop algorithm is active; and to assess expectations and treatment satisfaction of the closed-loop system.
Study design:
This study is a monocenter randomized cross-over trial.
Study population:
The study population will comprise 20 patients with T1DM, between 12 and 18 years old, not having impaired awareness of hypoglycaemia, and who are treated with insulin therapy for at least 6 months. Patients receiving treatment with multiple daily injections (MDI) or continuous subcutaneous insulin injections (CSII), and in addition glucose monitoring using self-monitored blood glucose (SMBG), flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) are included into the study.
Intervention:
The intervention includes 2 weeks of closed-loop control with the artificial pancreas (AP) of Inreda Diabetic. The device uses 2 subcutaneous glucose sensors, 2 subcutaneous infusion sets, and incorporates 2 pumps and a reactive closed-loop algorithm. During 4-6 days before the intervention the patients receive training on the use of the closed-loop system and will start using the device under close supervision. The control arm (open loop treatment) consists of the patient's standard therapy at home for 2 weeks.
Main study parameters/endpoints:
Main study parameter is the percentage of time spent in the target range (3.9-10.0 mmol/L), which will be compared between the open and closed-loop periods for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a monocenter, randomized cross-over trial. The total duration of the study will be three months: two weeks open loop control and 4-6 training days followed by a two-week closed-loop period, or vice versa, with at least 2 weeks in between.
| Arm | Type | Receives |
|---|---|---|
| Open loop control | Active comparator | Device: Open-loop controlIn this arm, the patients will use their usual diabetes therapy. Additionally, patients will wear a blinded DexcomG6 for data collection during the open loop period. |
| Bi-hormonal closed-loop control | Experimental | Device: Bi-hormonal closed-loop controlIn this arm, treatment consists of the bi-hormonal closed-loop system. A short acting insulin analogue (Humalog, 3 ml pre-filled cartridge, Eli Lilly) and glucagon (Glucagen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) will be administered according to the closed-loop algorithm. Additionally, patients will wear a blinded DexcomG6 for data collection during the closed loop period. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with type 1 diabetes mellitus
- Twelve to eighteen years old;
- Treated with insulin therapy for at least 6 months;
- Willing and able to sign informed consent or to assent to study participation.
Key exclusion criteria (10 listed)
- Impaired awareness of hypoglycaemia (score ≥ 4) according to Gold and/or Clarke questionnaire[6,7];
- BMI ≥ 35 kg/m2;
- Pregnancy and/or breastfeeding;
- HbA1c > 97 mmol/mol (11.0%);
- Use of acetaminophen (paracetamol) during the open loop or closed-loop period,as this may influence the sensor glucose measurements;
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 |
|---|---|---|
| Bi-hormonal closed-loop controlAlso: Artificial Pancreas (AP), bi-hormonal AP system, AP5During bi-hormonal closed-loop control insulin and glucagon are administered to the developed closed-loop algorithm. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the closed loop period. | Device | Bi-hormonal closed-loop control |
| Open-loop controlDuring open-loop control the patients will use their usual diabetes therapy. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the open loop period. | Device | Open loop control |
Primary outcome
Time in range
Time frame: 2 weeks
The proportion of time spent in the range of 3.9-10.0 mmol/L in %
22 secondary outcomes
Time in hypoglycemia 1
Time frame: 2 weeks
Time in hypoglycemia 2
Time frame: 2 weeks
Time in hyperglycemia 1
Time frame: 2 weeks
Time in hyperglycemia 2
Time frame: 2 weeks
Mean glucose concentration
Time frame: 2 weeks
Median glucose concentration
Time frame: 2 weeks
Glycemic variability - Coefficient of variation
Time frame: 2 weeks
Glycemic variability - Interquartile range
Time frame: 2 weeks
Mean glucose concentration during the day
Time frame: 2 weeks
Mean glucose concentration during the night (12PM - 6AM)
Time frame: 2 weeks
Median glucose concentration during the day (6AM - 12PM)
Time frame: 2 weeks
Median glucose concentration during the night (12PM - 6AM)
Time frame: 2 weeks
Time spent in hypoglycemia during the night
Time frame: 2 weeks
Time spent in hyperglycemia during the night
Time frame: 2 weeks
Time spent in euglycemia during the night
Time frame: 2 weeks
Time spent in hypoglycemia during the day
Time frame: 2 weeks
Time spent in hyperglycemia during the day
Time frame: 2 weeks
Time spent in euglycemia during the day
Time frame: 2 weeks
Algorithm active time
Time frame: 2 weeks
Expectations
Time frame: 2 weeks
Trust
Time frame: 2 weeks
Satisfaction
Time frame: 2 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 14 Aug 2023.
- 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.
Arianne Bon, MD, PhD principal investigator
Rijnstate ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus, Type 1, run by Inreda Diabetic B.V. 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 4 inclusion and 10 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 14 Aug 2023. 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.
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 range (time frame: 2 weeks). 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 14 Aug 2023.