NCT07087340

Brief 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 values from a continuous glucose meter. Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

July 24, 2025

Last Update Submit

February 10, 2026

Conditions

Type-1-Diabetes

Keywords

Automated insulin deliveryArtificial pancreas

Outcome Measures

Primary Outcomes (6)

  • Percentage of time with the system functioning in closed-loop mode

    10 hours

  • Failure rate of the HCL algorithm

    10 hours

  • Failure rate of the communication with CGM device

    10 hours

  • Failure rate of the communication with Insulin pump

    10 hours

  • Failure rate of the user interface (BernSHELL)

    10 hours

  • Failure rate of the web monitoring tool (DigiCARE)

    10 hours

Study Arms (1)

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.

Device: UBLoop System

Interventions

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.

UBLoop Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Universitätsspital; Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

Bern, 3010, Switzerland

RECRUITING

Study Officials

  • Markus Laimer, Prof.Dr.med.

    Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kizito Mbata

CONTACT

+41 31 664 07 47kizito.mbata@insel.ch

Markus Laimer, Prof.Dr.med.

CONTACT

+41 31 632 40 70markus.laimer@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Single-center, single-arm, supervised study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 28, 2025

Study Start

January 21, 2026

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)