Clinical trial NCT04701424: Closed-loop in Adults With T2D Not Requiring Dialysis
Official title: An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Comparison With Standard Care in Adults With Type 2 Diabetes Not Requiring Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
type 2 diabetes
closed-loop
artificial pancreas
insulin pump therapy
continuous glucose monitoring
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over an 8 week period 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 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting.

This is an open-label, single centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 8 weeks long with a 2-4 week washout period between treatments. A total of up to 30 participants with T2D will be recruited through outpatient clinics to allow for 24 completed participants available for assessment.

Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system.

The primary outcome is time spent with glucose levels in the target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or over
2. Diagnosis of type 2 diabetes using standard diagnostic practice
3. Current treatment with subcutaneous insulin
4. Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
5. Subject is willing to perform regular finger-prick blood glucose monitoring
6. Willingness to wear study devices
7. Literate in English

Exclusion Criteria:

1. Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
2. Known or suspected allergy to insulin
3. Lack of reliable telephone facility for contact
4. Pregnancy, planned pregnancy, or breast feeding
5. Severe visual impairment
6. Severe hearing impairment
7. Medically documented allergy towards the adhesive (glue) of plasters
8. Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
9. Illicit drugs abuse
10. Prescription drugs abuse
11. Alcohol abuse

Primary outcomes:
measure: Time in the target glucose range (3.9 to 10.0 mmol/l)
timeFrame: 8 week intervention period
Secondary outcomes:
measure: Time spent above target glucose (10.0 mmol/l)
timeFrame: 8 week intervention period, both arms
measure: Mean glucose
timeFrame: 8 week intervention period, both arms
measure: Time spent in hypoglycaemia (<3.9 mmol/l)
timeFrame: 8 week intervention period, both arms
measure: Standard deviation of glucose levels
timeFrame: 8 week intervention period, both arms
measure: Coefficient of variation of glucose levels
timeFrame: 8 week intervention period, both arms
measure: Time spent below <3.0 mmol/l
timeFrame: 8 week intervention period, both arms
measure: Time in hyperglycaemia > 16.7 mmol/l
timeFrame: 8 week intervention period, both arms
measure: Time in significant hyperglycaemia (> 20 mmol/l)
timeFrame: 8 week intervention period, both arms
measure: Glycated haemoglobin (HbA1c)
timeFrame: 8 week intervention period, both arms
measure: Total insulin dose
timeFrame: 8 week intervention period, both arms
Other outcomes:
measure: Number of episodes of severe hypoglycaemia
timeFrame: 8 week intervention period, both arms
measure: Number of subjects experiencing severe hypoglycaemia
timeFrame: 8 week intervention period, both arms
measure: Frequency and nature of other adverse events or serious adverse events
timeFrame: 8 week intervention period, both arms
measure: Percentage of time of closed-loop operation
timeFrame: 8 week intervention period, both arms
measure: Percentage of time of CGM availability
timeFrame: 8 week intervention period, both arms
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Roman Hovorka, PhD
role: PRINCIPAL_INVESTIGATOR
References: