Fully Automated Insulin Pump System versus Insulin Pen with Sensor in Type 2 Diabetes
Summary description of the study
This study investigates how safe and helpful a new fully automated insulin delivery system is. This system is called myLife CamAPS HX. It automatically adjusts the amount of insulin based on the current blood sugar level. The aim is to improve blood sugar control for people with diabetes. This is a multicenter efficacy study. In Bern, we aim to recruit 15 participants. First, there will be an informational meeting. If you agree and meet the inclusion criteria, you will provide written consent to participate. After that, there will be an introductory phase lasting 2 to 3 weeks. During this time, you will continue your usual insulin therapy and additionally wear a continuous glucose monitor (CGM sensor) that records your values. This will allow us to determine your baseline blood sugar control. Afterwards, participants will be randomly assigned to one of two groups: Group with automated insulin pump system: You will use the “myLife CamAPS HX system” with an insulin pump, CGM sensor, and smartphone app for 26 weeks. The system automatically calculates and delivers the appropriate amount of insulin. Group with standard therapy: You will continue your usual insulin therapy and wear a CGM sensor for blood sugar measurement for 26 weeks. All participants will receive an introduction and training on how to properly use their respective system. There will be up to 5 visits at the study center and regular contacts via phone or email to discuss progress, clarify questions, and collect important health data. The main goal of the study is to compare long-term blood sugar levels (HbA1c) between the groups after 26 weeks. Other important metrics include the time spent in the target range for blood sugar and how often blood sugar is too high or too low. All participants will receive the necessary devices and support during the study. Travel expenses will be reimbursed, and the devices must be returned after the study.
(BASEC)
Intervention under investigation
Currently, in Switzerland, people with Type 2 diabetes who are insulin-dependent are treated with an insulin pen. An automated insulin pump system is an alternative therapy form, where insulin is continuously delivered to the body based on current needs. In this study, we investigate the use of such an automated insulin pump system on health in general and blood sugar in particular. The automated insulin pump system used in this study is called "myLife CamAPS HX" and consists of three parts:
1.) An insulin pump called "Ypsopump," which delivers insulin into the subcutaneous fat tissue via a tube (catheter set). The insulin pump is typically carried in a pocket or clipped to the pants and is connected to the catheter set via the abdomen. The catheter set must be changed every two to three days.
2.) A glucose sensor called FreeStyle Libre 3, which is adhered to the skin and continuously measures blood sugar levels in the subcutaneous fat tissue using a filament (through a chemical reaction).
3.) A therapy algorithm called "myLife CamAPS HX," which uses the information from the glucose sensor to "decide" how much insulin needs to be delivered to the body. Thus, the automated insulin pump system continuously delivers the required amount of insulin to the body.
All study participants in the intervention group will wear the above-described insulin pump system on their body for 26 weeks. They will be supported by the study team but must independently maintain the system, which includes catheter changes and insulin vial changes.
(BASEC)
Disease under investigation
Type 2 Diabetes
(BASEC)
-18 years or older -Diagnosis of Type 2 diabetes (for at least 12 months) -Co-medication with an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, or medical recommendation for this medication -Treatment with insulin for at least 6 months -HbA1c ≤ 15% (according to laboratory examination in Switzerland) -Consent to wear the study devices for the duration of the study and to follow the instructions of the study team. -In possession of all necessary mental capacities to provide consent to participate in the study. (BASEC)
Exclusion criteria
-Type 1 diabetes -current use of an insulin pump -current use of an automated insulin pump system -any physical or mental illness that could likely affect the conduct of the study or the interpretation of study results, as assessed by the study physician -known or suspected allergy to insulin -medically documented allergy to medical adhesives (e.g., for bandages) -pregnancy, planned pregnancy, or breastfeeding -severe visual impairment -severe hearing impairment -severe skin disease in the area of the body intended for the placement of the glucose sensor -drug abuse -medication abuse -alcohol abuse -for female participants: lack of a reliable contraceptive method during the study duration -inability to provide consent for participation -lack of German language skills (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselspital, Universitätsspital Bern, Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin und Metabolismus UDEM (Studienzenter Schweiz)
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. et phil. Lia Bally
+41 31 632 36 77
lia.bally@clutterinsel.chInselspital, Universitätsspital Bern Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin und Me-tabolismus UDEM Freiburgstrasse 15 3010 Bern
(BASEC)
Scientific Information
University of Cambridge,
+44 (0)1223 769066
lia.bally@clutterinsel.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
18.06.2025
(BASEC)
ICTRP Trial ID
NCT06579404 (ICTRP)
Official title (approved by ethics committee)
An open-label, multi-national, multi-centre, randomised, single-period parallel study to assess the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with CGM in adults with type 2 diabetes (COYOTE study). (BASEC)
Academic title
An Open-label, Multinational, Multicentre, Randomised, Single-period Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes (ICTRP)
Public title
Closed-loop in Adults With Type 2 Diabetes (ICTRP)
Disease under investigation
Type 2 Diabetes Treated With Insulin (ICTRP)
Intervention under investigation
Device: CamAPS HXOther: Standard insulin therapy with glucose sensor (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Aged 18 years and older
- Type 2 diabetes diagnosed for at least 12 months
- Established on an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3
months, or have been offered these therapies previously.
- Treatment with insulin therapy for at least 6 months
- HbA1c = 15% (140 mmol/mol) analysis from local laboratory or equivalent
- Willing to wear study devices and follow study instructions
- Capacity to consent to participate in the study
Exclusion Criteria:
- Type 1 diabetes
- Current use of insulin pump
- Current use of any closed-loop system
- Any physical/psychological disease or medication(s) likely to interfere with the
conduct of the study and interpretation of the study results, as judged by study
clinician
- Known or suspected allergy against insulin
- Medically documented allergy towards the adhesive
- Pregnancy, planned pregnancy, or breast feeding
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters
- Serious skin diseases located at places of the body, which potentially are possible
to be used for localisation of the glucose sensor
- Illicit drugs abuse
- Prescription drugs abuse
- Alcohol abuse (ICTRP)
not available
Primary and secondary end points
Glycated haemoglobin (HbA1c) at 26 weeks (ICTRP)
Body Mass Index (BMI);Fasted lipid profile;Renal function;Renal function;Renal function;Liver function;Liver function;Liver function;Liver function;Liver function;Liver function;Liver function;Proportion of time spent above target glucose (>16.7mmol/l);Proportion of time spent above target glucose (>20.0mmol/l);Proportion of participants with HbA1c <7.0% [53mmol/mol] (%);Proportion of participants with HbA1c <7.5% [58mmol/mol] (%);Total daily insulin dose;Body weight;Waist hip ratio;Proportion of time spent in target glucose range (3.9 to 10.0mmol/L);Mean glucose (mmol/L);Proportion of time spent above target glucose (>10.0mmol/l);Proportion of time spent below target glucose (<3.9mmol/L);Standard deviation of sensor glucose;Coefficient of variation of sensor glucose;Proportion of time spent below target glucose (<3.5mmol/L);Proportion of time spent below target glucose (<3.0mmol/L);Proportion of time spent above target glucose (>13.9mmol/l) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Edinburgh;Jaeb Center for Health Research;Swansea University (ICTRP)
Additional contacts
Roman Hovorka;Charlotte K Boughton, PhD, cb2000@medschl.cam.ac.uk, +44 (0)1223 769066, University of Cambridge, (ICTRP)
Secondary trial IDs
COYOTE (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06579404 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available