Closed-loop in Adults With T2D Not Requiring Dialysis

Type 2 Diabetes Clinical Trial

— AP-Renal  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701424
• Other study ID #: RG97920
• Status: Completed
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2022
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• CamAPS HX Closed-loop
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.

Other:
• Multiple Daily Insulin Injections (Control)
Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of episodes of severe hypoglycaemia	Safety evaluation	8 week intervention period, both arms
Other	Number of subjects experiencing severe hypoglycaemia	Safety evaluation	8 week intervention period, both arms
Other	Frequency and nature of other adverse events or serious adverse events	Safety evaluation	8 week intervention period, both arms
Other	Percentage of time of closed-loop operation	Utility evaluation	8 week intervention period, both arms
Other	Percentage of time of CGM availability	Utility evaluation	8 week intervention period, both arms
Primary	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	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
Secondary	Mean glucose	Mean sensor glucose level	8 week intervention period, both arms
Secondary	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
Secondary	Standard deviation of glucose levels	Standard deviation of glucose levels	8 week intervention period, both arms
Secondary	Coefficient of variation of glucose levels	Coefficient of variation of glucose levels	8 week intervention period, both arms
Secondary	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
Secondary	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
Secondary	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
Secondary	Glycated haemoglobin (HbA1c)	HbA1c measured at the end of each study period	8 week intervention period, both arms
Secondary	Total insulin dose	Average daily total insulin requirements	8 week intervention period, both arms