Type 1 Diabetes MellitusDAN06NCT04025762

24/7 Closed-loop in Older Subjects With Type 1 Diabetes

A study testing Hybrid closed-loop system (CamAPS FX) and Sensor augmented pump therapy in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by University of Cambridge at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Type 1 Diabetes Mellitus, Hypoglycemia, Arrythmia
What is being tested?: Hybrid closed-loop system (CamAPS FX) and Sensor augmented pump therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 2 sitesUnited Kingdom
Study dates: 1 Sep 2019to 20 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 60 years and above
Type 1 diabetes as defined by WHO for at least 1 year or confirmed C-peptide negative
On insulin pump for at least 3 months with good knowledge of insulin self-adjustment
Treated with one of the U-100 rapid acting insulin analogues only (insulin Aspart, Lispro, Faster insulin Aspart but not Glulisine)
Willing to perform regular capillary blood glucose monitoring
HbA1c ≤ 10% (86 mmol/mmol) based on analysis from central laboratory or equivalent

Show all 12Show fewer

Literate in English
Having a care partner who is aware of the subject's location and is trained to administer intramuscular glucagon and able to seek emergency assistance
Willing to wear closed-loop system at home and at work place
Willing to follow study specific instructions
Willing to upload pump and CGM data at regular intervals
Has access to WiFi

Who cannot join

Non-type 1 diabetes mellitus
Use of a closed-loop system within the last 30 days
Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs) in the 3 months prior to enrolment or any use of SGLT2 inhibitors
Untreated coeliac disease, adrenal insufficiency or hypothyroidism
Known or suspected allergy against insulin

Show all 29Show fewer

More than one episodes of severe hypoglycaemia as defined by American Diabetes Association in preceding 6 months
Random C-peptide > 200pmol/l with concomitant plasma glucose >4 mmol/l (72 mg/dl)
Lack of reliable telephone facility for contact
Total daily insulin dose >/= 2 IU/kg/day
Total daily insulin dose < 15 IU/day
Severe visual impairment
Severe hearing impairment
Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
Subject is currently abusing illicit drugs
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject has elective surgery planned that requires general anaesthesia during the course of the study
Subject is a shift worker with working hours between 10pm and 8am
Subject has a sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject diagnosed with current eating disorder such as anorexia or bulimia
Subject plans to use significant quantity of herbal preparations (use of over the counter herbal preparation for 30 consecutive days or longer period during the study) or significant quantity of vitamin supplements (four times the recommended daily allowance used for 30 consecutive days or longer period during the study) known to affect glucose metabolism and/or blood glucose levels during the course of their participation in the study
Subject not proficient in English (UK), or German (Austria)
Additional exclusion criteria specific for Austria
Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
Positive alcohol breath test.
Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Manchester Royal Infirmary
Manchester

Other trials in United Kingdom

About this study

Official title: An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of 16 Week Day and Night Automated Closed-loop Glucose Control Under Free Living Conditions Compared to Sensor Augmented Insulin Pump Therapy in Older Adults With Type 1 Diabetes.

The main objective of this open-label, multi-centre, randomised, crossover design study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180 mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmias and objective sleep quality assessment will also be evaluated in this study.

Read the detailed description

No study thus far has specifically evaluated use of closed-loop insulin delivery in older adults with type 1 diabetes. During our previous closed-loop studies, if there is a communication failure between the algorithm device and the insulin pump, the pump is set to deliver pre-programmed basal insulin rates after about 30 to 60 minutes.The main objective of this study is to determine whether automated day and night closed-loop insulin delivery for 16 weeks under free living conditions is safer and more efficacious compared to sensor augmented insulin pump therapy in older adults with type 1 diabetes.

This is an open-label, multi-centre, randomised, crossover design study, involving a 4-6 week run-in period, followed by two 4 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by sensor-augmented pump therapy in random order. A total of up to 42 adults (aiming for 36 completed subjects) aged 60 years and older with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 6 weeks of the first intervention period will be replaced.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L (70 and 180mg/dl) as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of human factor assessments, cardiac arrhythmia and objective sleep quality assessment will also be evaluated in this study.

Conditions: Type 1 Diabetes Mellitus, Hypoglycemia, Arrythmia
Being tested: Hybrid closed-loop system (CamAPS FX), Sensor augmented pump therapy
Medical subject headings: Diabetes Mellitus, Type 1, Hypoglycemia, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hybrid closed-loop system (CamAPS FX)Device
Hybrid closed-loop system
Sensor augmented pump therapyDevice
Sensor augmented pump therapy

Study groups in NCT04025762
Study group	Role	What they receive
Day and night hybrid closed loop control	Experimental	The day and night hybrid closed-loop system (CamAPS FX) will consist of: * Dana RS insulin pump (Sooil) * G6 real-time CGM sensor (Dexcom) * An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm Receives: Device: Hybrid closed-loop system (CamAPS FX)
Sensor augmented pump therapy	Active comparator	The comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom) Receives: Device: Sensor augmented pump therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)
Proportion of 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: 16 weeks

Secondary outcomes (9)

HbA1c at the End of the 16 Week Intervention Period (mmol/Mol)
Measured: 16 weeks
Proportion of Time Spent Below Target Glucose (3.9mmol/l) (70mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Measured: 16 weeks
Proportion of Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Measured: 16 weeks
Average (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
Measured: 16 weeks
Proportion of Time With Glucose Levels < 3.5 mmol/l (63mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Measured: 16 weeks
Proportion of Time With Glucose Levels in the Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Measured: 16 weeks
Total Daily Insulin Dose During the 16 Week Intervention Period (Units/Day)
Measured: 16 weeks
Standard Deviation (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
Measured: 16 weeks
Proportion of Time With Glucose Levels < 3.0 mmol/l (54mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201920 Aug 2021

First posted19 Jul 2019
Study start1 Sep 2019
Primary completion20 Aug 2021
Study completion20 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies 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, multi-centre randomised, two-period crossover study comparing day and night automated closed-loop glucose control with sensor-augmented pump therapy.
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04025762
Sponsor's protocol ID: DAN06
Acronym: DAN06
Status last verified: Dec 2024
First submitted: 16 Jul 2019
Last updated: 6 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
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

Schneider-Utaka AK, Hanes S, Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Hayes J, Wilinska ME, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R, Hood KK. Patient-reported outcomes for older adults on CamAPS FX closed loop system. Diabet Med. 2023 Sep;40(9):e15126. doi: 10.1111/dme.15126. Epub 2023 May 23.
PubMed 37171467
Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Wilinska ME, Hood KK, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R. Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study. Lancet Healthy Longev. 2022 Mar;3(3):e135-e142. doi: 10.1016/S2666-7568(22)00005-8. Epub 2022 Mar 7.
PubMed 35359882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multi-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of 16 Week Day and Night Automated Closed-loop Glucose Control Under Free Living Conditions Compared to Sensor Augmented Insulin Pump Therapy in Older Adults With Type 1 Diabetes.
ClinicalTrials.gov ID: NCT04025762
Acronym / sponsor ID: DAN06 / DAN06
Conditions: Type 1 Diabetes Mellitus, Hypoglycemia, Arrythmia
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of CambridgeUniversity, hospital or other
Collaborators: Manchester University NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Medical University of Graz
Study start: 1 Sep 2019 (actual)
Primary completion: 20 Aug 2021 (actual)
Study completion: 20 Aug 2021 (actual)
First posted: 19 Jul 2019 (actual)
Results: Posted 6 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: An open-label, multi-centre randomised, two-period crossover study comparing day and night automated closed-loop glucose control with sensor-augmented pump therapy.

Arm	Type	Receives
Day and night hybrid closed loop control	Experimental	Device: Hybrid closed-loop system (CamAPS FX)The day and night hybrid closed-loop system (CamAPS FX) will consist of: * Dana RS insulin pump (Sooil) * G6 real-time CGM sensor (Dexcom) * An unlocked android smartphone hosting the CamAPS FX app with Cambridge control algorithm
Sensor augmented pump therapy	Active comparator	Device: Sensor augmented pump therapyThe comparator will consist of Dana RS insulin pump (Sooil) and G6 real-time CGM sensor (Dexcom)

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age 60 years and above
Type 1 diabetes as defined by WHO for at least 1 year or confirmed C-peptide negative
On insulin pump for at least 3 months with good knowledge of insulin self-adjustment
Treated with one of the U-100 rapid acting insulin analogues only (insulin Aspart, Lispro, Faster insulin Aspart but not Glulisine)
Willing to perform regular capillary blood glucose monitoring

Key exclusion criteria (29 listed)

Non-type 1 diabetes mellitus
Use of a closed-loop system within the last 30 days
Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs) in the 3 months prior to enrolment or any use of SGLT2 inhibitors
Untreated coeliac disease, adrenal insufficiency or hypothyroidism

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
Hybrid closed-loop system (CamAPS FX)Hybrid closed-loop system	Device	Day and night hybrid closed loop control
Sensor augmented pump therapySensor augmented pump therapy	Device	Sensor augmented pump therapy

Primary outcome

Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Proportion of 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)

9 secondary outcomes

HbA1c at the End of the 16 Week Intervention Period (mmol/Mol)
Time frame: 16 weeks
Proportion of Time Spent Below Target Glucose (3.9mmol/l) (70mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Proportion of Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Average (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
Time frame: 16 weeks
Proportion of Time With Glucose Levels < 3.5 mmol/l (63mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Proportion of Time With Glucose Levels in the Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks
Total Daily Insulin Dose During the 16 Week Intervention Period (Units/Day)
Time frame: 16 weeks
Standard Deviation (mmol/L) of CGM Glucose Levels During the 16 Week Intervention Period
Time frame: 16 weeks
Proportion of Time With Glucose Levels < 3.0 mmol/l (54mg/dl) Based on CGM During the 16 Week Intervention Period (%)
Time frame: 16 weeks

Results and safety

Results posted to the registry on 6 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Initial Use of Day and Night Hybrid Closed Loop Control Followed by Sensor Augmented Pump Therapy	20	20
Initial Use of Sensor Augmented Pump Therapy Followed by Day and Night Hybrid Closed-loop Control	17	17

Primary outcome: Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%)

Time frame: 16 weeks. Mean (Standard Deviation). Unit: % of time

Measure	Day and Night Hybrid Closed Loop Control n = 36	Sensor Augmented Pump Therapy n = 37
Value	79.9 (7.9)	71.4 (13.2)

Population analysed: Crossover study design

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety evaluation comprised the frequency of severe hypoglycaemia and diabetic ketoacidosis, and other adverse events or serious adverse events. Data were collected from recruitment until the final study visit, up to 10 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Day and Night Hybrid Closed Loop Control	0 of 36 (0%)	4 of 36 (11.1%)	0 of 36
Sensor Augmented Pump Therapy	1 of 37 (2.7%)	7 of 37 (18.9%)	1 of 37
Run-in Period	1 of 37 (2.7%)	2 of 37 (5.4%)	0 of 37
Washout Period	0 of 36 (0%)	1 of 36 (2.8%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37171467Schneider-Utaka AK, Hanes S, Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Hayes J, Wilinska ME, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R, Hood KK. Patient-reported outcomes for older adults on CamAPS FX closed loop system. Diabet Med. 2023 Sep;40(9):e15126. doi: 10.1111/dme.15126. Epub 2023 May 23.
Derived from this study: PubMed 35359882Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, Wilinska ME, Hood KK, Mader JK, Narendran P, Leelarathna L, Evans ML, Hovorka R. Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study. Lancet Healthy Longev. 2022 Mar;3(3):e135-e142. doi: 10.1016/S2666-7568(22)00005-8. Epub 2022 Mar 7.
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.

Roman Hovorka, PhD principal investigator

University of Cambridge

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 29 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 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Time Spent in the Target Sensor Glucose Range During the 16 Week Intervention Period (%) (time frame: 16 weeks). 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 NCT04025762, 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 6 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.