Type 2 DiabetesAP-RenalNCT04701424
Closed-loop in Adults With T2D Not Requiring Dialysis
A study testing CamAPS HX Closed-loop in people with Type 2 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CamAPS HX Closed-loop
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
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
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.
Read more
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.
- Conditions
- Type 2 Diabetes
- Being tested
- CamAPS HX Closed-loop, Multiple Daily Insulin Injections (Control)
- Keywords
- diabetes, type 2 diabetes, closed-loop, artificial pancreas, insulin pump therapy, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPS HX Closed-loopDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Closed loop insulin delivery | Experimental | 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 Receives: Device: CamAPS HX Closed-loop |
| Standard therapy | Active comparator | 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 Receives: Other: Multiple Daily Insulin Injections (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 week intervention period
Secondary outcomes (10)
Time spent above target glucose (10.0 mmol/l)
Percentage of time spent with sensor glucose readings above target glucose (10.0 mmol/l)
Measured: 8 week intervention period, both arms
Mean glucose
Mean sensor glucose level
Measured: 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
Measured: 8 week intervention period, both arms
Standard deviation of glucose levels
Standard deviation of glucose levels
Measured: 8 week intervention period, both arms
Coefficient of variation of glucose levels
Coefficient of variation of glucose levels
Measured: 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
Measured: 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
Measured: 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)
Measured: 8 week intervention period, both arms
Glycated haemoglobin (HbA1c)
HbA1c measured at the end of each study period
Measured: 8 week intervention period, both arms
Total insulin dose
Average daily total insulin requirements
Measured: 8 week intervention period, both arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start16 Dec 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701424
- Sponsor's protocol ID
- RG97920
- Acronym
- AP-Renal
- Status last verified
- May 2022
- First submitted
- 6 Jan 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
Publications
Daly AB, Boughton CK, Nwokolo M, Hartnell S, Wilinska ME, Cezar A, Evans ML, Hovorka R. Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial. Nat Med. 2023 Jan;29(1):203-208. doi: 10.1038/s41591-022-02144-z. Epub 2023 Jan 11.
PubMed 36631592
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04701424
- Acronym / sponsor ID
- AP-Renal / RG97920
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, type 2 diabetes, closed-loop, artificial pancreas, insulin pump therapy, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed loop insulin delivery | Experimental | Device: CamAPS HX Closed-loopUnsupervised 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 |
| Standard therapy | Active comparator | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamAPS HX Closed-loopThe 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 | Closed loop insulin delivery |
| Multiple Daily Insulin Injections (Control)Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA) | Other | Standard therapy |
Primary outcome
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
10 secondary outcomes
Time spent above target glucose (10.0 mmol/l)
Time frame: 8 week intervention period, both arms
Mean glucose
Time frame: 8 week intervention period, both arms
Time spent in hypoglycaemia (<3.9 mmol/l)
Time frame: 8 week intervention period, both arms
Standard deviation of glucose levels
Time frame: 8 week intervention period, both arms
Coefficient of variation of glucose levels
Time frame: 8 week intervention period, both arms
Time spent below <3.0 mmol/l
Time frame: 8 week intervention period, both arms
Time in hyperglycaemia > 16.7 mmol/l
Time frame: 8 week intervention period, both arms
Time in significant hyperglycaemia (> 20 mmol/l)
Time frame: 8 week intervention period, both arms
Glycated haemoglobin (HbA1c)
Time frame: 8 week intervention period, both arms
Total insulin dose
Time frame: 8 week intervention period, both arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 36631592Daly AB, Boughton CK, Nwokolo M, Hartnell S, Wilinska ME, Cezar A, Evans ML, Hovorka R. Fully automated closed-loop insulin delivery in adults with type 2 diabetes: an open-label, single-center, randomized crossover trial. Nat Med. 2023 Jan;29(1):203-208. doi: 10.1038/s41591-022-02144-z. Epub 2023 Jan 11.
- Individual participant dataSharing planned: Yes. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
Related trials for Type 2 Diabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Hovorka, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CamAPS HX Closed-loop in people with Type 2 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in the target glucose range (3.9 to 10.0 mmol/l) (time frame: 8 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04701424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.