Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump

A study of Type 1 Diabetes, run by Imperial College London at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This clinical study assesses the feasibility of implementing the inControl automated insulin delivery algorithm with Dexcom continuous glucose monitoring and a compatible insulin pump in adults with type 1 diabetes. It additionally provides pilot efficacy outcomes for interoperable automated insulin delivery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Apr 2022to 31 Aug 2025
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

Aged 18 years of age or older
Type 1 diabetes confirmed on the basis of clinical features
Type 1 diabetes for greater than 1 year
On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)

Who cannot join

Total daily insulin dose greater than 100 units
Weight greater than 140kg
Pregnant or planning pregnancy
Have active malignancy or under investigation for malignancy
Severe visual impairment
Reduced manual dexterity
Use of any automated insulin delivery system
Unable to participate due to other factors, as assessed by the Chief Investigator

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Imperial College London, Imperial College Healthcare NHS Trust
London, W2 1PG

Other trials in United Kingdom

About this study

Read the detailed description

Self-management of type 1 diabetes is challenging, efforts to optimise time spent in the target range can result in hypo- and hyperglycaemia. Structured education, glucose monitoring and advances in insulin delivery can increase time in range and reduce exposure to extremes of glucose and recent data confirm that automated insulin delivery can enable further increases in time spent in the target range of 3.9 to 10mmol/L (70 - 180mg/dL).

The inControl algorithm, developed by TypeZero technologies is embedded in the Tandem X2 insulin pump and operates with the Dexcom G6 continuous glucose sensor and transmitter in a CE-marked and commercially available system (known as Control-IQ). This system optimises time in range compared with sensor-augmented pump therapy, and the improvement was maintained when participants were further randomised to predictive low glucose suspend or automated insulin delivery. The United States Food and Drug Administration has defined interoperable standards for automated insulin delivery systems, including the iCGM designation for continuous glucose sensors, the interoperable automated glycaemic controller designation, and alternate controller enabled insulin pumps. However, while standards have been defined, to date, interoperability of automated insulin delivery components has not been demonstrated.

Conditions: Type 1 Diabetes
Being tested: InControl
Keywords: automated insulin delivery
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.

InControlDevice
Automated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)

Study groups in NCT05299177
Study group	Role	What they receive
Automated Insulin Delivery	Experimental	The components of the automated insulin delivery system are the Dexcom G6 continuous glucose monitor (CGM), the InControl algorithm and an insulin pump (Ypsomed Ypsopump). The Dexcom G6 continuous glucose monitoring device is an approved device and is licensed to be used to inform insulin dosing decisions without confirmation. The algorithm (inControl 1.0) is approved when used embedded in the Tandem X2 insulin pump. We are using the algorithm for its intended purpose but are implementing it in a smartphone app to be installed in a compatible smartphone (Android). We are additionally assessing incremental benefit with the next software version of the algorithm. This will be the first time this updated software has been assessed in people with type 1 diabetes. The compatible insulin pump is a continuous subcutaneous insulin infusion device and is being used in line with its intended purpose, according to the manufacturer's instructions (YpsoMed Ypsopump). Receives: Device: InControl

What is being measured

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

% time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
Consensus measure of time in range
Measured: Extracted from the final 28 days of the intervention period

Secondary outcomes (18)

% time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)
Consensus measure of time in range
Measured: Extracted from the final 28 days of the intervention period
% time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)
Consensus measure of time in range
Measured: Extracted from the final 28 days of the intervention period
% time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Consensus measure of time in range
Measured: Extracted from the final 28 days of the intervention period
% time spent in hyperglycaemia (>10mmol/L, 180mg/dL)
Consensus measure of time in range
Measured: Extracted from the final 28 days of the intervention period
Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)
Consensus measure of exposure to hypoglycaemia
Measured: Over 12 week intervention period
Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)
Consensus measure of exposure to hypoglycaemia
Measured: Over 12 week intervention period
Severe hypoglycaemia (defined as requiring third party assistance)
Consensus measure of exposure to hypoglycaemia
Measured: Over 12 week intervention period
Glucose variability assessed by %Coefficient of Variation (%CV)
Consensus measure of glucose variability
Measured: Extracted from the final 28 days of the intervention period
Glucose variability assessed by Mean Absolute Glucose (MAG)
Consensus measure of glucose variability
Measured: Extracted from the final 28 days of the intervention period
Glucose variability assessed by Low Blood Glucose Index (LBGI)
Consensus measure of glucose variability
Measured: Extracted from the final 28 days of the intervention period
HbA1c
Laboratory HbA1c assessment
Measured: At end of 12 week intervention period
Time spent in automated insulin delivery mode
% of total time that automated insulin delivery is active
Measured: Over 12 week intervention period
Treatment satisfaction (DTSQ, AP acceptability)
Validated patient reported outcome
Measured: At end of 12 week intervention period
Gold score
Validated patient reported outcome of hypoglycaemia awareness (1-7, with greater value indicating loss of awareness)
Measured: At end of 12 week intervention period
Diabetes distress (DDS-17)
Validated patient reported outcome, Diabetes Distress Score 17 item, higher scores mean greater distress
Measured: At end of 12 week intervention period
Diabetes distress (PAID)
Validated patient reported outcome, Problem Areas In Diabetes 20 item
Measured: At end of 12 week intervention period
Change in total daily insulin dose (units)
Total insulin delivered by system per day
Measured: At end of 12 week intervention period
Change in weight (kg)
Weight in kg
Measured: At end of 12 week intervention period

Timeline

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

1 Apr 202231 Aug 2025

First posted28 Mar 2022
Study start1 Apr 2022
Primary completion31 Aug 2025
Study completion31 Aug 2025

Why it stopped: Study device not available

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05299177
Sponsor's protocol ID: 20HH5892
Acronym: BELIEVE
Status last verified: Sep 2025
First submitted: 17 Feb 2022
Last updated: 3 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump
ClinicalTrials.gov ID: NCT05299177
Acronym / sponsor ID: BELIEVE / 20HH5892
Conditions: Type 1 Diabetes
Keywords: automated insulin delivery
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study device not available
Enrolment: 1 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: DexCom, Inc.
Study start: 1 Apr 2022 (actual)
Primary completion: 31 Aug 2025 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 28 Mar 2022 (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.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Automated Insulin Delivery	Experimental	Device: InControlThe components of the automated insulin delivery system are the Dexcom G6 continuous glucose monitor (CGM), the InControl algorithm and an insulin pump (Ypsomed Ypsopump). The Dexcom G6 continuous glucose monitoring device is an approved device and is licensed to be used to inform insulin dosing decisions without confirmation. The algorithm (inControl 1.0) is approved when used embedded in the Tandem X2 insulin pump. We are using the algorithm for its intended purpose but are implementing it in a smartphone app to be installed in a compatible smartphone (Android). We are additionally assessing incremental benefit with the next software version of the algorithm. This will be the first time this updated software has been assessed in people with type 1 diabetes. The compatible insulin pump is a continuous subcutaneous insulin infusion device and is being used in line with its intended purpose, according to the manufacturer's instructions (YpsoMed Ypsopump).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged 18 years of age or older
Type 1 diabetes confirmed on the basis of clinical features
Type 1 diabetes for greater than 1 year
On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)

Key exclusion criteria (8 listed)

Total daily insulin dose greater than 100 units
Weight greater than 140kg
Pregnant or planning pregnancy
Have active malignancy or under investigation for malignancy
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
InControlAutomated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)	Device	Automated Insulin Delivery

Primary outcome

% time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
Time frame: Extracted from the final 28 days of the intervention period
Consensus measure of time in range

18 secondary outcomes

% time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)
Time frame: Extracted from the final 28 days of the intervention period
% time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)
Time frame: Extracted from the final 28 days of the intervention period
% time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Time frame: Extracted from the final 28 days of the intervention period
% time spent in hyperglycaemia (>10mmol/L, 180mg/dL)
Time frame: Extracted from the final 28 days of the intervention period
Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)
Time frame: Over 12 week intervention period
Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)
Time frame: Over 12 week intervention period
Severe hypoglycaemia (defined as requiring third party assistance)
Time frame: Over 12 week intervention period
Glucose variability assessed by %Coefficient of Variation (%CV)
Time frame: Extracted from the final 28 days of the intervention period
Glucose variability assessed by Mean Absolute Glucose (MAG)
Time frame: Extracted from the final 28 days of the intervention period
Glucose variability assessed by Low Blood Glucose Index (LBGI)
Time frame: Extracted from the final 28 days of the intervention period
HbA1c
Time frame: At end of 12 week intervention period
Time spent in automated insulin delivery mode
Time frame: Over 12 week intervention period
Treatment satisfaction (DTSQ, AP acceptability)
Time frame: At end of 12 week intervention period
Gold score
Time frame: At end of 12 week intervention period
Diabetes distress (DDS-17)
Time frame: At end of 12 week intervention period
Diabetes distress (PAID)
Time frame: At end of 12 week intervention period
Change in total daily insulin dose (units)
Time frame: At end of 12 week intervention period
Change in weight (kg)
Time frame: At end of 12 week intervention period

Results and safety

The study was stopped early (reason given: Study device not available). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Individual participant dataSharing planned: No

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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 of Type 1 Diabetes, run by Imperial College London 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Sep 2025. 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 was stopped early (reason given: Study device not available). Results are not available in the source record.

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 spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL) (time frame: Extracted from the final 28 days of the 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 NCT05299177.

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 3 Sep 2025.