Type 2 Diabetes
Conditions
Keywords
diabetes, type 2 diabetes, closed-loop, artificial pancreas, insulin pump therapy, continuous glucose monitoring
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.
Interventions
DEVICECamAPS 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.
Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)
Sponsors
University of Cambridge
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Glycated haemoglobin (HbA1c) | 8 week intervention period, both arms | HbA1c measured at the end of each study period |
| Total insulin dose | 8 week intervention period, both arms | Average daily total insulin requirements |
| 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 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 |
| Coefficient of variation of glucose levels | 8 week intervention period, both arms | Coefficient of variation of glucose levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency and nature of other adverse events or serious adverse events | 8 week intervention period, both arms | Safety evaluation |
| Percentage of time of closed-loop operation | 8 week intervention period, both arms | Utility evaluation |
| Percentage of time of CGM availability | 8 week intervention period, both arms | Utility evaluation |
| Number of subjects experiencing severe hypoglycaemia | 8 week intervention period, both arms | Safety evaluation |
| Number of episodes of severe hypoglycaemia | 8 week intervention period, both arms | Safety evaluation |
Countries
United Kingdom
Outcome results
None listed