Closed-loop in Adults With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CamAPS HX, Standard insulin therapy with glucose sensor.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Treated With Insulin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Austria, Czechia, France, Switzerland +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes (T2D). This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes. This is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices. The primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol/L) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM \& closed-loop usage, questionnaires and semi-structured interviews.
Detailed description
Purpose of clinical trial:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
Study objectives:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
1. EFFICACY: The objective is to assess the ability of fully closed-loop insulin delivery to improve glucose control as measured by HbA1c (primary endpoint) and sensor glucose metrics. 2. SAFETY: The objective is to evaluate the safety of fully closed-loop insulin delivery in terms of episodes and severity of hypoglycaemia, and nature and severity of other adverse events. 3. UTILITY: The objective is to determine the acceptability and duration of use of the CGM and closed-loop system. 4. HUMAN FACTORS: The objective is to assess cognitive, emotional, and behavioural characteristics of participants and their response to the closed-loop system using validated questionnaires and semi-structured interviews.
Participating clinical centres:
UK - Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust. - Imperial College Healthcare NHS Trust, London
\- Manchester Royal Infirmary, Manchester University NHS Foundation Trust
\- King's College Hospital, King's College Hospital NHS Foundation Trust, London
\- Guy's and St Thomas' NHS Foundation Trust
\- Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust
\- University Hospitals of Leicester NHS Trust
Switzerland
\- Inselspital, Bern University Hospital, Bern
France
\- Centre Hospitalier Universitaire (CHU) de Toulouse
Germany
\- Medical Center - University of Freiburg
Austria
\- Medical University of Graz, Graz
Czech Republic
\- Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague
Sample Size:
224 participants (112 per group) will be randomised. Recruitment will target a minimum quota of 25% of participants using basal insulin and a minimum quota of 60% of participants using multiple daily insulin injections.
Maximum duration of study for a subject: 30 weeks
Recruitment:
Participants will be recruited through outpatient diabetes clinics, primary care centres, social media advertising or other established methods at participating centres
Consent:
Participants will be asked to provide written informed consent.
Baseline Assessment:
Eligible participants will undergo baseline evaluation involving talking a medical history including demographics, height/weight, waist hip ratio and blood pressure measurement and blood samples for HbA1c, fasted lipid profile, renal and liver function. A urine albumin-creatinine ratio (ACR) will be performed, along with a urine pregnancy test in females of child-bearing age. Human factors questionnaires will be completed and a masked glucose sensor will be applied.
Run-in Period:
During a 2-3 week run-in period, participants will use their usual insulin therapy and wear a masked CGM system. At the end of the run-in period, for compliance, at least 10 days of CGM data needs to be recorded. CGM data during the run-in period will be used to assess baseline glucose control before the start of the intervention phase.
Randomisation:
Eligible participants will be randomised in a 1:1 ratio using central randomisation software to fully closed-loop or standard insulin therapy with CGM for 26 weeks. Randomisation will be stratified by site and baseline HbA1c.
Fully closed loop insulin delivery (intervention arm):
Following randomisation, participants in the closed-loop group will receive training on the study CGM, study insulin pump and closed-loop App during a 1-2 hour outpatient session. Competency on the use of the closed-loop system will be evaluated. Further training may be delivered as required. Participants will be advised to use the closed-loop system for the next 26 weeks.
Standard insulin therapy with CGM (control arm):
Following randomisation, participants in the control group will use their usual insulin therapy and the study CGM. Training on the use of the CGM will be provided. Participants will use standard insulin therapy and CGM for the next 26 weeks.
3 month study visit: Weight, waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c, fasted lipid profile, renal and liver function. Data from the closed-loop system and CGM system will be reviewed. Human factors questionnaires will be completed.
Interventions
- Device CamAPS HX
The automated closed loop system (CamAPS HX) will consist of: YpsoPump insulin pump Freestyle Libre 3 glucose sensor Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm - Other Standard insulin therapy with glucose sensor
Participants usual insulin therapy with Freestyle Libre 3 glucose sensor
Primary outcome measures
- Glycated haemoglobin (HbA1c) at 26 weeks [Time frame: at 26 weeks]
Secondary outcome measures (12)
- Proportion of time spent in target glucose range (3.9 to 10.0mmol/L) [Time frame: over 26 weeks]
- Mean glucose (mmol/L) [Time frame: over 26 weeks]
- Proportion of time spent above target glucose (>10.0mmol/l) [Time frame: over 26 weeks]
- Proportion of time spent below target glucose (<3.9mmol/L) [Time frame: over 26 weeks]
- Standard deviation of sensor glucose [Time frame: over 26 weeks]
- Coefficient of variation of sensor glucose [Time frame: over 26 weeks]
- Proportion of time spent below target glucose (<3.5mmol/L) [Time frame: over 26 weeks]
- Proportion of time spent below target glucose (<3.0mmol/L) [Time frame: over 26 weeks]
- Proportion of time spent above target glucose (>13.9mmol/l) [Time frame: over 26 weeks]
- Proportion of time spent above target glucose (>16.7mmol/l) [Time frame: over 26 weeks]
- Proportion of time spent above target glucose (>20.0mmol/l) [Time frame: over 26 weeks]
- Proportion of participants with HbA1c <7.0% [53mmol/mol] (%) [Time frame: at 26 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 7 centers
- Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust — Cambridge
- Royal Derby Hospital — Derby
- Leicester Diabetes Centre — Leicester
- Guy's and St Thomas' NHS Foundation Trust — London
- King's College Hospital, King's College NHS Foundation Trust — London
- Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust — Manchester
- Norfolk and Norwich University Hospital — Norwich
Australia · 1 center
- University of Melbourne — Melbourne
Austria · 1 center
- Medical University of Graz — Graz
Czechia · 1 center
- Diabetes Centre, Institute of Clinical and Experimental Medicine — Prague
France · 1 center
- CHU de Toulouse — Toulouse
Switzerland · 1 center
- Bern University Hospital — Bern
Publications
- Seese R, Boughton CK, Tseung FT, Uy R, Wilinska ME, Thabit H, Cheah YS, Neupane S, Hussain S, Choudhary P, Wilmot EG, Bally L, Hanaire H, Mader JK, Haluzik M, O'Neal D, Lawton J, Rankin D, Kollman C, Dunseath G, Hovorka R. Assessing the efficacy, safety and utility of fully closed-loop insulin delivery compared to standard insulin therapy with a continuous glucose monitor in adults with type 2 dia PMID 42156154
Identifiers
NCT: NCT06579404 · COYOTE