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Completed

NCT Number: NCT04701424

Closed-loop in Adults With T2D Not Requiring Dialysis

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CamAPS HX Closed-loop

Device

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 (Control)

Other

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

Primary outcomes

  1. Time in the target glucose range (3.9 to 10.0 mmol/l)

    Time frame: 8 week intervention period

    Percentage of time spent with sensor glucose readings in the target range from 3.9 to 10.0mmol/l

Secondary outcomes

  1. Time spent above target glucose (10.0 mmol/l)

    Time frame: 8 week intervention period, both arms

    Percentage of time spent with sensor glucose readings above target glucose (10.0 mmol/l)

  2. Mean glucose

    Time frame: 8 week intervention period, both arms

    Mean sensor glucose level

  3. Time spent in hypoglycaemia (<3.9 mmol/l)

    Time frame: 8 week intervention period, both arms

    Percentage of time spent with sensor glucose readings <3.9 mmol/L

  4. Standard deviation of glucose levels

    Time frame: 8 week intervention period, both arms

    Standard deviation of glucose levels

  5. Coefficient of variation of glucose levels

    Time frame: 8 week intervention period, both arms

    Coefficient of variation of glucose levels

  6. Time spent below <3.0 mmol/l

    Time frame: 8 week intervention period, both arms

    Percentage of time spent with sensor glucose readings <3.0 mmol/l

  7. Time in hyperglycaemia > 16.7 mmol/l

    Time frame: 8 week intervention period, both arms

    Percentage of time with glucose levels in hyperglycaemia > 16.7 mmol/l

  8. Time in significant hyperglycaemia (> 20 mmol/l)

    Time frame: 8 week intervention period, both arms

    Percentage of time with glucose levels in significant hyperglycaemia (> 20 mmol/l)

  9. Glycated haemoglobin (HbA1c)

    Time frame: 8 week intervention period, both arms

    HbA1c measured at the end of each study period

  10. Total insulin dose

    Time frame: 8 week intervention period, both arms

    Average daily total insulin requirements

Other outcomes

  1. Number of episodes of severe hypoglycaemia

    Time frame: 8 week intervention period, both arms

    Safety evaluation

  2. Number of subjects experiencing severe hypoglycaemia

    Time frame: 8 week intervention period, both arms

    Safety evaluation

  3. Frequency and nature of other adverse events or serious adverse events

    Time frame: 8 week intervention period, both arms

    Safety evaluation

  4. Percentage of time of closed-loop operation

    Time frame: 8 week intervention period, both arms

    Utility evaluation

  5. Percentage of time of CGM availability

    Time frame: 8 week intervention period, both arms

    Utility evaluation

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Registry information

Official study 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

Acronym: AP-Renal

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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