Closed-loop in Adults With Type 2 Diabetes

Launched by UNIVERSITY OF CAMBRIDGE · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage blood sugar levels in adults with type 2 diabetes who use insulin. The researchers want to see if a fully closed-loop glucose control system, which automatically adjusts insulin delivery based on glucose levels, works effectively and safely in a home setting compared to standard insulin therapy. The trial will involve approximately 224 adults aged 18 and older who have been diagnosed with type 2 diabetes for at least a year. To be eligible, participants need to be on certain diabetes medications and insulin therapy, and their blood sugar levels must be within a specific range.

Participants can expect to be part of the study for about 26 weeks, where they will either use the closed-loop system or continue their usual insulin treatment while wearing a device that monitors their glucose levels. Throughout the study, they will receive training on how to use the devices safely. The researchers will check how well each method controls blood sugar, how much insulin is needed, and if there are any side effects. This trial is important as it could help improve diabetes management for many people living with this condition.

Gender

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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