Closed-loop in Adults With T2D Not Requiring Dialysis

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Multiple Daily Insulin Injections (Control); Device: CamAPS HX Closed-loop

• Registration Number: NCT04701424
• Lead Sponsor: University of Cambridge

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-16
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard therapy	Multiple Daily Insulin Injections (Control)	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
Closed loop insulin delivery	CamAPS HX Closed-loop	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

Primary Outcome Measures

Name	Time	Method
Time in the target glucose range (3.9 to 10.0 mmol/l)	8 week intervention period	Percentage of time spent with sensor glucose readings in the target range from 3.9 to 10.0mmol/l

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom