Closed-loop in Adults With T2D Not Requiring Dialysis

Study Overview
=================
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.

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

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Device: CamAPS HX Closed-loop
* Other: Multiple Daily Insulin Injections (Control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or over Diagnosis of type 2 diabetes using standard diagnostic practice Current treatment with subcutaneous insulin Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory Subject is willing to perform regular finger-prick blood glucose monitoring Willingness to wear study devices Literate in English Exclusion Criteria: 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 Known or suspected allergy to insulin Lack of reliable telephone facility for contact 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed loop insulin delivery<br>Unsupervised home use of day and night fully automated closed loop insulin delivery system (CamAPS HX) for 8 weeks The CamAPS HX closed-loop system comprises: Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data | Device: CamAPS HX Closed-loop<br>* The CamAPS HX closed-loop system comprises: Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data.<br>|
| Active Comparator: Standard therapy<br>Participants in the control arm will continue to follow their current diabetes management plan for the 8 week study period. Participants will be wear a masked continuous glucose monitoring (CGM) system during the 8 week study period | Other: Multiple Daily Insulin Injections (Control)<br>* Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in the target glucose range (3.9 to 10.0 mmol/l) | Percentage of time spent with sensor glucose readings in the target range from 3.9 to 10.0mmol/l | 8 week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent above target glucose (10.0 mmol/l) | Percentage of time spent with sensor glucose readings above target glucose (10.0 mmol/l) | 8 week intervention period, both arms | 
| Mean glucose | Mean sensor glucose level | 8 week intervention period, both arms | 
| Time spent in hypoglycaemia (<3.9 mmol/l) | Percentage of time spent with sensor glucose readings <3.9 mmol/L | 8 week intervention period, both arms | 
| Standard deviation of glucose levels | Standard deviation of glucose levels | 8 week intervention period, both arms | 
| Coefficient of variation of glucose levels | Coefficient of variation of glucose levels | 8 week intervention period, both arms | 
| Time spent below <3.0 mmol/l | Percentage of time spent with sensor glucose readings <3.0 mmol/l | 8 week intervention period, both arms | 
| Time in hyperglycaemia > 16.7 mmol/l | Percentage of time with glucose levels in hyperglycaemia > 16.7 mmol/l | 8 week intervention period, both arms | 
| Time in significant hyperglycaemia (> 20 mmol/l) | Percentage of time with glucose levels in significant hyperglycaemia (> 20 mmol/l) | 8 week intervention period, both arms | 
| Glycated haemoglobin (HbA1c) | HbA1c measured at the end of each study period | 8 week intervention period, both arms | 
| Total insulin dose | Average daily total insulin requirements | 8 week intervention period, both arms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, type 2 diabetes, closed-loop, artificial pancreas, insulin pump therapy, continuous glucose monitoring