Type-1-DiabetesUBLoop-GenNCT07087340
Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop-Genesis
A study testing UBLoop System in people with Type-1-Diabetes, run by University of Bern at 1 site in Switzerland.
Trial summary
The study is investigating the early feasibility of a novel algorithm for a hybrid closed-loop (HCL) insulin delivery system in adult patients with Type 1 diabetes. Participants will attend a study visit where the UBLoop system on a smartphone will manage insulin delivery via an insulin pump, using blood glucose… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type-1-Diabetes
- What is being tested?
- UBLoop System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Jan 2026to 27 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1D diagnosis for at least one year.
- Aged between 18 and 65 years old (inclusive).
- Currently using insulin for at least six months.
- Currently using closed-loop insulin therapy for at least three months.
- Willingness to suspend any personal CGM for the duration of the pilot study once the study CGM is in place.
- Willingness not to start any new non-insulin glucose-lowering agent during the study (including metformin/biguanides, incretin agonists [GIP/GLP-1RAs or GLP-1RAs], pramlintide, DPP-4 inhibitors, sulfonylureas, Sodium-glucose cotransporter-2 inhibitors [SGLT2 inhibitors], and nutraceuticals).
- Understanding and willingness to follow the protocol and signed informed consent.
Who cannot join
- An HbA1C ≥10% .
- History of diabetic ketoacidosis (DKA) in the past 12 months.
- History of severe hypoglycaemic event (Level 3): defined as seizure or loss of consciousness in the past 12 months.
- Current uncontrolled chronic diabetic microvascular complications (neuropathy, retinopathy, renal diabetes disease, and diabetic gastroparesis).
- Body Mass Index (BMI) ≤18.5 or ≥ 35 kg m2
- Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2
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- Pregnancy or intent to become pregnant during the study.
- Currently breastfeeding or planning to breastfeed.
- Currently uncontrolled seizure disorder.
- Planned surgery during the study duration.
- Have uncontrolled hypertension (systolic BP above or equal to 160 mmHg and/or diastolic BP above or equal to 100 mmHg). If a participant is on anti-hypertensive therapies, doses must be stable for 30 days before screening. For participants with uncontrolled hypertension at the screening visit, antihypertensive medication may be started or adjusted.*
- Personal history of one of the following cardiovascular conditions: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) in the last three months before the screening.
- Conditions that may increase the risk of induced hypoglycemia such as known coronary artery disease, CHF (Have NYHA Functional Classification III or IV CHF), history of any cardiac disorder or arrhythmia, history of cerebrovascular event, hypoglycemia-induced migraine within the past six months, seizure disorder, syncope, adrenal insufficiency, or neurological disease).
- Cystic fibrosis.
- Uncontrolled thyroid disease as judged by the investigator.
- Have an uncontrolled psychiatric condition such as (major depressive disorder, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder, alcohol or drug abuse).
- Treatment with a non-insulin glucose-lowering agent, except metformin, in stable doses in the last three months.
- Participants receiving or have received systemic glucocorticoid therapy within three months before screening (Prednisolone 10mg daily or equivalent >2 weeks) or chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations).
- Have current treatment with (or history of, within 3 months before screening) medications that may affect glucose metabolism, as judged by the investigator.
- Current enrolment in another clinical trial, unless approved by the investigator of both studies, and if the clinical trial is a non-interventional registry trial.
- Have evidence of a significant active, uncontrolled medical condition or a history of any medical problem capable of constituting a risk when using the study devices or interfering with the interpretation of data, as judged by the study physician at screening.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital, Universitätsspital; Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
Bern, Canton of Bern, 3010
About this study
Official title: Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop - Genesis
The study is investigating the early feasibility of a novel algorithm for a hybrid closed-loop (HCL) insulin delivery system in adult patients with Type 1 diabetes.
Participants will attend a study visit where the UBLoop system on a smartphone will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter. Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants.
- Conditions
- Type-1-Diabetes
- Being tested
- UBLoop System
- Keywords
- Automated insulin delivery, Artificial pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBLoop SystemDevice
Participants (people living with Type-1-Diabetes) will attend a study visit where the UBLoop system will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter (CGM). Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants. The investigational product comprises (1) the BernSHELL App, communicating with the CGM and the insulin pump, (2) the UBLoop algorithm receiving CGM data, processing the control algorithm, calculating insulin dosing, checking the safety of the calculated insulin injections, and transmitting instructions to the insulin pump via BernSHELL, (3) the UBLoop Cloud providing secure storage, analytics support, and data backup, (4) DigiCare, monitoring the safety of the study participants and the system's execution flow in real time.
During the intervention, participants will use the Ypsomed myLife YpsoPump (insulin pump) and the Dexcom G6 or G7 CGM.
| Study group | Role | What they receive |
|---|---|---|
| UBLoop Intervention Group | Experimental | For a period of approximately 10 hours, study participants will wear an insulin pump and a continuous glucose monitor (CGM), with the UBLoop system controlling insulin delivery based on the CGM readings. The UBLoop system will be operating via an app installed on a smartphone. Receives: Device: UBLoop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time with the system functioning in closed-loop mode
Measured: 10 hours
Failure rate of the HCL algorithm
Measured: 10 hours
Failure rate of the communication with CGM device
Measured: 10 hours
Failure rate of the communication with Insulin pump
Measured: 10 hours
Failure rate of the user interface (BernSHELL)
Measured: 10 hours
Failure rate of the web monitoring tool (DigiCARE)
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start21 Jan 2026
- Primary completion27 Jun 2026
- Study completion27 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-1-DiabetesStudies of the same condition, open and under way.
- More trials run by University of BernThe 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm, supervised study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- DCB Research AG, DexCom, Inc., mylife Diabetes Care AG
- Responsible party
- Sponsor
- Investigators
- Markus Laimer, Prof.Dr.med., Principal investigator, Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087340
- Sponsor's protocol ID
- 2025-D0056
- Acronym
- UBLoop-Gen
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop - Genesis
- ClinicalTrials.gov ID
- NCT07087340
- Acronym / sponsor ID
- UBLoop-Gen / 2025-D0056
- Conditions
- Type-1-Diabetes
- Keywords
- Automated insulin delivery, Artificial pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- DCB Research AG, DexCom, Inc., mylife Diabetes Care AG
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 27 Jun 2026 (actual)
- Study completion
- 27 Jun 2026 (actual)
- First posted
- 28 Jul 2025 (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 study is investigating the early feasibility of a novel algorithm for a hybrid closed-loop (HCL) insulin delivery system in adult patients with Type 1 diabetes.
Participants will attend a study visit where the UBLoop system on a smartphone will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter. Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, supervised study
| Arm | Type | Receives |
|---|---|---|
| UBLoop Intervention Group | Experimental | Device: UBLoop SystemFor a period of approximately 10 hours, study participants will wear an insulin pump and a continuous glucose monitor (CGM), with the UBLoop system controlling insulin delivery based on the CGM readings. The UBLoop system will be operating via an app installed on a smartphone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- T1D diagnosis for at least one year.
- Aged between 18 and 65 years old (inclusive).
- Currently using insulin for at least six months.
- Currently using closed-loop insulin therapy for at least three months.
- Willingness to suspend any personal CGM for the duration of the pilot study once the study CGM is in place.
Key exclusion criteria (21 listed)
- An HbA1C ≥10% .
- History of diabetic ketoacidosis (DKA) in the past 12 months.
- History of severe hypoglycaemic event (Level 3): defined as seizure or loss of consciousness in the past 12 months.
- Current uncontrolled chronic diabetic microvascular complications (neuropathy, retinopathy, renal diabetes disease, and diabetic gastroparesis).
- Body Mass Index (BMI) ≤18.5 or ≥ 35 kg m2
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 |
|---|---|---|
| UBLoop SystemParticipants (people living with Type-1-Diabetes) will attend a study visit where the UBLoop system will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter (CGM). Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants. The investigational product comprises (1) the BernSHELL App, communicating with the CGM and the insulin pump, (2) the UBLoop algorithm receiving CGM data, processing the control algorithm, calculating insulin dosing, checking the safety of the calculated insulin injections, and transmitting instructions to the insulin pump via BernSHELL, (3) the UBLoop Cloud providing secure storage, analytics support, and data backup, (4) DigiCare, monitoring the safety of the study participants and the system's execution flow in real time. During the intervention, participants will use the Ypsomed myLife YpsoPump (insulin pump) and the Dexcom G6 or G7 CGM. | Device | UBLoop Intervention Group |
Primary outcome
Percentage of time with the system functioning in closed-loop mode
Time frame: 10 hours
Failure rate of the HCL algorithm
Time frame: 10 hours
Failure rate of the communication with CGM device
Time frame: 10 hours
Failure rate of the communication with Insulin pump
Time frame: 10 hours
Failure rate of the user interface (BernSHELL)
Time frame: 10 hours
Failure rate of the web monitoring tool (DigiCARE)
Time frame: 10 hours
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 16 Jul 2026.
- 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.
Markus Laimer, Prof.Dr.med. principal investigator
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UBLoop System in people with Type-1-Diabetes, run by University of Bern at 1 site in Switzerland.
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 7 inclusion and 21 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 16 Jul 2026. 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 Switzerland. 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?
Percentage of time with the system functioning in closed-loop mode (time frame: 10 hours). The study lists 6 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 16 Jul 2026.