Type 1 DiabetesNCT04977908
Closing the Loop in Adults With Type 1 Diabetes (CLEAR)
A study testing CamAPS HX and Standard insulin pump therapy with CGM in people with Type 1 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The main objective of this study is to determine whether home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin is superior to standard insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes on insulin pump therapy with sub-optimal glycaemic control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CamAPS HX and Standard insulin pump therapy with CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2021to 31 May 2023
- 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
- The participant has type 1 diabetes as defined by WHO for at least 1 year
- The participant is 18 years of age or older
- The participant will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment
- The participant is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro, ultra-rapid Lispro insulin or Insulin Glulisine)
- HbA1c ≥8.0% (64 mmol/mol) based on analysis from local laboratory
- The participant is willing to wear closed-loop devices
- The participant is willing to follow study specific instructions
- Female participants of child bearing age should using effective contraception and must have a negative urine-HCG pregnancy test at screening.
Who cannot join
- Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Known or suspected allergy against insulin
- Total daily insulin dose > 2 IU/kg/day
- Use of a closed-loop system within the past 30 days
- Participant is pregnant or breast feeding or planning pregnancy within next 12 months
- Severe visual impairment
Show all 9Show fewer
- Severe hearing impairment
- Lack of reliable telephone facility for contact
- Participant not proficient in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
About this study
Official title: An Open-label, Single-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Closed-loop Glucose Control Compared to Standard Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adults With Type 1 Diabetes (CLEAR Study)
The main objective of this study is to determine whether home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin is superior to standard insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes on insulin pump therapy with sub-optimal glycaemic control (HbA1c ≥ 8.0%).
This is an open-label, single centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using ultra-rapid Lispro insulin or by participants usual insulin pump therapy with continuous glucose monitoring in random order. A total of up to 30 adults (aiming for 24 completed participants) with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods. Participants who drop out of the study within the first 4 weeks of the first intervention arm will be replaced.
Read more
Participants will receive appropriate training in the safe use of the closed-loop devices. Participants will have access to the study team during the home study phase with 24/7 telephone support.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM over the 8 week period. Secondary outcomes are HbA1c, 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 severe hypoglycaemic episodes, diabetic ketoacidosis (DKA) events and other adverse and serious adverse events.
Read the detailed description
Purpose of the clinical trial:
To determine whether home use of fully closed-loop applying ultra-rapid Lispro insulin is superior to insulin pump therapy with continuous glucose monitoring (CGM).
Study objective:
The study objective is to compare home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin with standard insulin pump therapy with CGM.
- EFFICACY: The objective is to assess the efficacy of fully closed-loop glucose control applying ultra-rapid Lispro insulin in maintaining CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, as compared to standard insulin pump therapy combined with CGM.
- SAFETY: The objective is to evaluate the safety of fully closed-loop glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other adverse events and adverse device effects.
- UTILITY: The objective is to determine the percentage of time when closed-loop was operational, and usability and acceptance of the closed-loop system.
Participating clinical centres:
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge
Sample Size:
24 adults completing the study. Up to 30 participants will be recruited to allow for dropouts.
Maximum duration of study for a participant:
20 weeks (5 months)
Recruitment The participants will be recruited through the adult diabetes outpatient clinics or other established methods.
Consent:
Participants will be asked to provide written informed consent.
Baseline Assessment:
Eligible participants will undergo a baseline evaluation including a blood sample for the measurement of HbA1c, renal, liver functions, full blood count, thyroid functions and coeliac antibody screen (if not done in the previous 3 months). Urine pregnancy test will be done in females of child bearing age. Human factor questionnaires will be administered.
Run-in Period During the 2-3 week run-in period, participants will use their own insulin pump and wear a masked CGM system. At the end of the run-in period, for compliance, at least 10 days of CGM data need to be recorded. CGM data during the run-in period will be used to assess baseline glucose control before the start of the first home study phase.
Randomisation:
Eligible participants will be randomised using randomisation software to the use of closed-loop glucose control or to standard pump therapy with CGM. There will be no washout period between the two intervention periods.
Automated closed-loop:
Training on the use of closed-loop will be provided by the research team during a 2 to 3 hour session in an outpatient setting (clinical research facility) or may be done remotely. Competency on the use of study insulin pump, study CGM and closed-loop system will be evaluated using a competency assessment tool developed by the research team. Further training may be delivered as required. Participants will be advised to use the closed-loop system with ultra-rapid Lispro insulin for next 8 weeks.
Conventional insulin pump therapy with CGM:
Participants will use their own insulin pump and study CGM. Training on the use of real-time CGM and how to interpret real-time will be provided. Participants will use standard insulin pump therapy, with their usual insulin, and real-time CGM for the next 8 weeks.
Cross-over Assessment:
At the end of the first intervention period, a blood sample for the measurement of HbA1c will be taken and human factor questionnaires will be administered.
End of study assessments:
A blood sample will be taken for measurement of HbA1c and human factor questionnaires will be administered. Study devices will be returned and participants will resume usual care.
Procedures for safety monitoring during trial:
Standard operating procedures for monitoring and reporting of all adverse events and adverse device events will be in place, including serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse events (AE) such as severe hypoglycaemia.
A data monitoring and ethics committee (DMEC) will be informed of all serious adverse events and any unanticipated adverse device/method effects that occur during the study and will review compiled adverse event data at periodic intervals.
Criteria for withdrawal of patients on safety grounds:
A participant may terminate participation in the study at any time without necessarily giving a reason and without any personal disadvantage. An investigator can stop the participation of a subject after consideration of the benefit/risk ratio. Possible reasons are:
- Serious adverse events
- Significant protocol violation or non-compliance
- Failure to satisfy competency assessment
- Decision by the investigator, or the sponsor, that termination is in the participant's best medical interest
- Pregnancy, planned pregnancy, or breast feeding
- Allergic reaction to insulin
- Technical grounds (e.g. participant relocates)
- Conditions
- Type 1 Diabetes
- Being tested
- CamAPS HX, Standard insulin pump therapy with CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamAPS HXDevice
Fully automated closed-loop system (CamAPS HX) with ultra-rapid Lispro insulin
Standard insulin pump therapy with CGMDevice
Participants usual insulin pump therapy with Dexcom G6 CGM
| Study group | Role | What they receive |
|---|---|---|
| Fully closed-loop system with ultra-rapid Lispro insulin | Experimental | The fully closed-loop system (CamAPS HX) will consist of:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm
* Cloud upload system to review CGM/insulin data.
Participants will use ultra-rapid Lispro insulin in the closed-loop system Receives: Device: CamAPS HX |
| Standard insulin pump therapy with CGM | Active comparator | Participants will use their own insulin pump and usual insulin throughout this study period.
The CGM will be the Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) Receives: Device: Standard insulin pump therapy with CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target glucose range
Time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM)
Measured: 8-week home use
Secondary outcomes (8)
Time spent above the target glucose range
Time spent above target glucose (10.0 mmol/l) (180 mg/dl) based on CGM
Measured: 8-week home use
Time spent below the target glucose range
Time spent below target glucose (3.9mmol/l) (70mg/dl) based on CGM
Measured: 8-week home use
Mean glucose
Average of sensor glucose levels
Measured: 8-week home use
Standard deviation and coefficient of variation of glucose
Standard deviation and coefficient of variation of CGM glucose levels
Measured: 8-week home use
Time spent in hypoglycaemia
Time with glucose levels < 3.0 mmol/l (54mg/dl) based on CGM
Measured: 8-week home use
Time spent in hyperglycaemia
Time with glucose levels >13.9 mmol/l (250mg/dl) and > 16.7 mmol/l) (300mg/dl)
Measured: 8-week home use
HbA1c
Glycated haemoglobin measured at the end of the treatment period
Measured: after 8-week home use
Total, basal, and bolus insulin dose
Total, basal, and bolus insulin dose
Measured: 8-week home use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start31 Aug 2021
- Primary completion31 Mar 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 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
- Model description
- An open-label, single-centre, randomised, two-period, crossover study comparing closed-loop glucose control compared to standard insulin pump therapy combined with continuous glucose monitoring
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977908
- Sponsor's protocol ID
- 291543
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. 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
Lakshman R, Hartnell S, Ware J, Allen JM, Wilinska ME, Nwokolo M, Evans ML, Hovorka R, Boughton CK. Lived Experience of Fully Closed-Loop Insulin Delivery in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Apr;26(4):211-221. doi: 10.1089/dia.2023.0394. Epub 2024 Feb 28.
PubMed 38426909Boughton CK, Hartnell S, Lakshman R, Nwokolo M, Wilinska ME, Ware J, Allen JM, Evans ML, Hovorka R. Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study. Diabetes Care. 2023 Nov 1;46(11):1916-1922. doi: 10.2337/dc23-0728.
PubMed 37616583
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Closed-loop Glucose Control Compared to Standard Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adults With Type 1 Diabetes (CLEAR Study)
- ClinicalTrials.gov ID
- NCT04977908
- Acronym / sponsor ID
- 291543
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 Jul 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 whether home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin is superior to standard insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes on insulin pump therapy with sub-optimal glycaemic control (HbA1c ≥ 8.0%).
This is an open-label, single centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using ultra-rapid Lispro insulin or by participants usual insulin pump therapy with continuous glucose monitoring in random order. A total of up to 30 adults (aiming for 24 completed participants) with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods. Participants who drop out of the study within the first 4 weeks of the first intervention arm will be replaced.
Participants will receive appropriate training in the safe use of the closed-loop devices. Participants will have access to the study team during the home study phase with 24/7 telephone support.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM over the 8 week period. Secondary outcomes are HbA1c, 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 severe hypoglycaemic episodes, diabetic ketoacidosis (DKA) events and other adverse and serious adverse events.
Detailed description
Purpose of the clinical trial:
To determine whether home use of fully closed-loop applying ultra-rapid Lispro insulin is superior to insulin pump therapy with continuous glucose monitoring (CGM).
Study objective:
The study objective is to compare home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin with standard insulin pump therapy with CGM.
- EFFICACY: The objective is to assess the efficacy of fully closed-loop glucose control applying ultra-rapid Lispro insulin in maintaining CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, as compared to standard insulin pump therapy combined with CGM.
- SAFETY: The objective is to evaluate the safety of fully closed-loop glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other adverse events and adverse device effects.
- UTILITY: The objective is to determine the percentage of time when closed-loop was operational, and usability and acceptance of the closed-loop system.
Participating clinical centres:
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge
Sample Size:
24 adults completing the study. Up to 30 participants will be recruited to allow for dropouts.
Maximum duration of study for a participant:
20 weeks (5 months)
Recruitment The participants will be recruited through the adult diabetes outpatient clinics or other established methods.
Consent:
Participants will be asked to provide written informed consent.
Baseline Assessment:
Eligible participants will undergo a baseline evaluation including a blood sample for the measurement of HbA1c, renal, liver functions, full blood count, thyroid functions and coeliac antibody screen (if not done in the previous 3 months). Urine pregnancy test will be done in females of child bearing age. Human factor questionnaires will be administered.
Run-in Period During the 2-3 week run-in period, participants will use their own insulin pump and wear a masked CGM system. At the end of the run-in period, for compliance, at least 10 days of CGM data need to be recorded. CGM data during the run-in period will be used to assess baseline glucose control before the start of the first home study phase.
Randomisation:
Eligible participants will be randomised using randomisation software to the use of closed-loop glucose control or to standard pump therapy with CGM. There will be no washout period between the two intervention periods.
Automated closed-loop:
Training on the use of closed-loop will be provided by the research team during a 2 to 3 hour session in an outpatient setting (clinical research facility) or may be done remotely. Competency on the use of study insulin pump, study CGM and closed-loop system will be evaluated using a competency assessment tool developed by the research team. Further training may be delivered as required. Participants will be advised to use the closed-loop system with ultra-rapid Lispro insulin for next 8 weeks.
Conventional insulin pump therapy with CGM:
Participants will use their own insulin pump and study CGM. Training on the use of real-time CGM and how to interpret real-time will be provided. Participants will use standard insulin pump therapy, with their usual insulin, and real-time CGM for the next 8 weeks.
Cross-over Assessment:
At the end of the first intervention period, a blood sample for the measurement of HbA1c will be taken and human factor questionnaires will be administered.
End of study assessments:
A blood sample will be taken for measurement of HbA1c and human factor questionnaires will be administered. Study devices will be returned and participants will resume usual care.
Procedures for safety monitoring during trial:
Standard operating procedures for monitoring and reporting of all adverse events and adverse device events will be in place, including serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse events (AE) such as severe hypoglycaemia.
A data monitoring and ethics committee (DMEC) will be informed of all serious adverse events and any unanticipated adverse device/method effects that occur during the study and will review compiled adverse event data at periodic intervals.
Criteria for withdrawal of patients on safety grounds:
A participant may terminate participation in the study at any time without necessarily giving a reason and without any personal disadvantage. An investigator can stop the participation of a subject after consideration of the benefit/risk ratio. Possible reasons are:
- Serious adverse events
- Significant protocol violation or non-compliance
- Failure to satisfy competency assessment
- Decision by the investigator, or the sponsor, that termination is in the participant's best medical interest
- Pregnancy, planned pregnancy, or breast feeding
- Allergic reaction to insulin
- Technical grounds (e.g. participant relocates)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, single-centre, randomised, two-period, crossover study comparing closed-loop glucose control compared to standard insulin pump therapy combined with continuous glucose monitoring
| Arm | Type | Receives |
|---|---|---|
| Fully closed-loop system with ultra-rapid Lispro insulin | Experimental | Device: CamAPS HXThe fully closed-loop system (CamAPS HX) will consist of: * Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) * Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) * An Android smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm * Cloud upload system to review CGM/insulin data. Participants will use ultra-rapid Lispro insulin in the closed-loop system |
| Standard insulin pump therapy with CGM | Active comparator | Device: Standard insulin pump therapy with CGMParticipants will use their own insulin pump and usual insulin throughout this study period. The CGM will be the Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant has type 1 diabetes as defined by WHO for at least 1 year
- The participant is 18 years of age or older
- The participant will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment
- The participant is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro, ultra-rapid Lispro insulin or Insulin Glulisine)
- HbA1c ≥8.0% (64 mmol/mol) based on analysis from local laboratory
Key exclusion criteria (9 listed)
- Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Known or suspected allergy against insulin
- Total daily insulin dose > 2 IU/kg/day
- Use of a closed-loop system within the past 30 days
- Participant is pregnant or breast feeding or planning pregnancy within next 12 months
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 HXFully automated closed-loop system (CamAPS HX) with ultra-rapid Lispro insulin | Device | Fully closed-loop system with ultra-rapid Lispro insulin |
| Standard insulin pump therapy with CGMParticipants usual insulin pump therapy with Dexcom G6 CGM | Device | Standard insulin pump therapy with CGM |
Primary outcome
Time in target glucose range
Time frame: 8-week home use
Time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM)
8 secondary outcomes
Time spent above the target glucose range
Time frame: 8-week home use
Time spent below the target glucose range
Time frame: 8-week home use
Mean glucose
Time frame: 8-week home use
Standard deviation and coefficient of variation of glucose
Time frame: 8-week home use
Time spent in hypoglycaemia
Time frame: 8-week home use
Time spent in hyperglycaemia
Time frame: 8-week home use
HbA1c
Time frame: after 8-week home use
Total, basal, and bolus insulin dose
Time frame: 8-week home use
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 21 Nov 2023.
- Derived from this study: PubMed 38426909Lakshman R, Hartnell S, Ware J, Allen JM, Wilinska ME, Nwokolo M, Evans ML, Hovorka R, Boughton CK. Lived Experience of Fully Closed-Loop Insulin Delivery in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Apr;26(4):211-221. doi: 10.1089/dia.2023.0394. Epub 2024 Feb 28.
- Derived from this study: PubMed 37616583Boughton CK, Hartnell S, Lakshman R, Nwokolo M, Wilinska ME, Ware J, Allen JM, Evans ML, Hovorka R. Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study. Diabetes Care. 2023 Nov 1;46(11):1916-1922. doi: 10.2337/dc23-0728.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Standard insulin pump therapy with CGM in people with Type 1 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 8 inclusion and 9 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 21 Nov 2023. 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 target glucose range (time frame: 8-week home use). 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 NCT04977908, which also lists 2 linked publications.
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 21 Nov 2023; AzTrials last refreshed its copy on 1 Nov 2026.