Diabetes Mellitus, Type 1LBY-T1NCT05217953
Improving HbA1c Levels Through Behavioural Change of Diabetes Self-management Assisted by the LovedBy Mobile Application for Young Adults and Adolescents With Type 1 Diabetes
A study testing LovedBy App in people with Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Young people (16-25) with type-1 diabetes have historically struggled with managing their condition. Typically, the average HbA1c levels are significantly higher and as such, the risk of long term complications tend to be far greater. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- LovedBy App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2022to 2 Feb 2024
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 1. Age between 16 - 25. 2. Type 1 diabetes, as defined by World Health Organisation (WHO) for at least 1 year or is confirmed C-peptide negative. 3. HbA1c between 7.5 - 14.0% based on analysis from local laboratory or equivalent within 3 months of enrolment.
- 4. Has an Apple smartphone compatible with Dexcom G6. 5. Willingness to download the LovedBy app on their smartphone. 6. Willingness to wear an apple smartwatch. 7. Willingness to wear a Dexcom CGM. 8. Literate in English.
Who cannot join
- 1. Non-type 1 diabetes mellitus including those secondary to chronic disease. 2. Biphasic insulin MDI pen users. 3. Any other physical or psychological disease is likely to interfere with the normal conduct of the study.
- 4. Untreated coeliac disease or hypothyroidism. 5. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers, MAO inhibitors etc.
- 6. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement. 7. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin disease) located at places of the body, which could potentially be used for localisation of the glucose sensor. 8. Lack of reliable telephone facility for contact. 9. Known or suspected allergy against insulin. 10. Severe visual impairment. 11. Severe hearing impairment. 12. Not proficient in English. 13. Pregnancy, or planning for pregnancy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M139WL
Hood Thabit, MD, PhD, 01612766102, Hood.Thabit@mft.nhs.uk
Mohammed Nazir, BSc, 01612766102, mohammed.nazir@mft.nhs.uk
About this study
Official title: A Single-centre, Randomised, Cross-over Design Efficacy Study to Assess the Effectiveness of App-based, Assisted Behavioural Change Techniques to Improve HbA1c Levels and Support Diabetes Self-management in Young Adults and Adolescents
Young people (16-25) with type-1 diabetes have historically struggled with managing their condition. Typically, the average HbA1c levels are significantly higher and as such, the risk of long term complications tend to be far greater.
These sufferers tend to have better management of their condition as they grow older however, the evidence suggests this is too late and these sufferers will likely have some complications later in life. Current cost to the NHS for complications is ~£850 million and expected to rise to ~£1.3 billion in the next 10-15 years.
Read more
The LovedBy solution aims to leverage modern technologies such as smartphones, continuous glucose monitors (CGM), and other smart wearables to assist young sufferers managing their condition. The LovedBy platform offers a mobile application which connects to the user's smart wearables and CGM to monitor data streams that have been linked to long term risk. The mobile application is then able to deliver personally relevant educational content to the user through numerous channels including private social media messages.
The study will last 10 months, and the participants are required to download/install the mobile app, integrate their wearables and then simply continue as normal with regular clinical meetings. Participants will be between 16-25 years and comply with the inclusion criteria set out in the protocol.
Read the detailed description
This study will recruit 40 participants suffering from type-1 diabetes, split across 2 groups, with 30 needed for statistical significance (10 extra to allow for dropouts). The participant will have their average HbA1c levels measured (lab based, CONTROL-1). While the participants are participating in the trial, they will receive relevant educational content based on areas of management they are struggling with. The analysis that decides this is automated by the system which explores whether the particular criteria have been met for each educational pieces.
At the end of the study we will be able to compare whether the primary outcome has been met by comparing a final average HbA1c measure to CONTROL-1. Secondary outcomes can be evaluated using the sensor HbA1c recordings.
The entire study can be summarised as a reference to a reduction in long term risk and cost saving to the NHS.
Participant Journey
Pre-Trial (Visit 1):
1-3 hours 2-4 weeks before study starts Firstly, the patient will be sent all relevant study documents after which there is the recruitment call where the study will be described in detail. All risks will be discussed here and made clear. The data policies and management of data will also be described here. The patient will be able to ask any questions they wish to do so at this point.
If the patient is willing to participate in the trial, consent will be obtained after the they have had adequate time to reflect on the study.
Once consent has been obtained, the participant will be able to undergo lab HbA1c sampling. The participant will also undertake a questionnaire (Diabetes Distress Scale). The questionnaire will be undertaken at intervals between the other tasks during this visit.
Trial (Visit-2):
1-2 hours Study starts The clinical research team (CRT) will collect various measures such as weight, height blood pressure, body fat etc.and also ensure the users CGM is set up correctly.
Test-Group: The CGM will be integrated with the users mobile handset and all relevant measures taken will be entered. Participant will be provided with a smart watch and this will also be integrated with the users smartphone.
The user will then download and install the LovedBy mobile app. Once installed the user will set up an account and the account number will be recorded by the clinical research team to track the participant throughout the trial. The final step is to review the permissions of the mobile application and allow the mobile application to connect to the users handset. Control-Group: The same measurements will be taken as with the test group but here no app will be provided to the participants in this group.
Trial (Visit-3):
1-2 hours 8-weeks since last visit Test-Group: Participants of this group will undergo an interview with clinical research team. They will discuss events that were identified by the LovedBy platform. The CRT will also update the measures taken in the previous visit. The participant will also be asked to partake in a semi-structured interview to asses phycological efficacy.
Control-Group: This group will not undergo an interview.
Trial (Visit-4):
1-2 hours 8-weeks since last visit All participants will end the first arm of the study with lab HbA1c recorded. They will then proceed with a 4-week washout period. After which they will cross-over to begin the second arm of the study.
Trial (Visit-5):
1-2 hours 4-weeks since last visit This visit will be identical to Visit-2 but the Test-Group and Control-Group will switch over.
Trial (Visit-6):
1-2 hours 8-weeks since last visit This visit will be identical to Visit-3 where only the Test-Group will be interviewed.
Trial (Visit-7):
1-2 hours 8-weeks since last visit All participant will undergo a lab HbA1c sampling. The participant will undergo an exit interview regarding their experience with and without the LovedBy app. During this exit interview all LovedBy resources provided to the user such as smartwatches, CGM and applications will be handed back and/or removed from the user's device. The interview will aim to better capture the qualitative efficacy of the platform. It will be analysed to identify areas of design improvements that can be made on the user interface and content pieces.
Study Complete (Correspondence):
The participants will be provided the results of the study electronically
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- LovedBy App
- 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.
LovedBy AppDevice
The LovedBy solution aims to leverage modern technologies such as smartphones, continuous glucose monitors (CGM), and other smart wearables to assist young sufferers managing their condition. The LovedBy platform offers a mobile application which connects to the user's smart wearables and CGM to monitor data streams that have been linked to long term risk. The mobile application is then able to deliver personally relevant educational content to the user through numerous channels including private social media message
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | The CGM will be integrated with the users mobile handset and all relevant measures taken will be entered. Participant will be provided with a smart watch and this will also be integrated with the users smartphone.
The user will then download and install the LovedBy mobile app. Once installed the user will set up an account and the account number will be recorded by the clinical research team to track the participant throughout the trial. The final step is to review the permissions of the mobile application and allow the mobile application to connect to the users handset Receives: Device: LovedBy App |
| Control-Group | No intervention | The same measurements will be taken as with the test group but here no app will be provided to the participants in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
primary objective is to assess change in HbA1c change at 4 months following use of the LovedBy digital solution and 4 months without the the LovedBy app. (Lab based measures.)
Measured: 4 months
Secondary outcomes (7)
Time spent below target glucose (3.9 mmol/l)
Time spent below target glucose (3.9 mmol/l)
Measured: 10 months
Time spent above target glucose (10.0 mmol/l)
Time spent above target glucose (10.0 mmol/l)
Measured: 10 months
Average, standard deviation, and coefficient of variation of glucose levels
Average, standard deviation, and coefficient of variation of glucose levels
Measured: 10 months
The time with glucose levels in hypoglycaemia at <3.5 mmol/l and <2.8 mmol/l
The time with glucose levels in hypoglycaemia at <3.5 mmol/l and <2.8 mmol/l
Measured: 10 months
The time with glucose levels in significant hyperglycaemia (>16.7 mmol/l)
The time with glucose levels in significant hyperglycaemia (>16.7 mmol/l)
Measured: 10 months
Total, basal and bolus insulin dose
Total, basal and bolus insulin dose
Measured: 10 months
AUC of glucose below 3.5 mmol/l
AUC of glucose below 3.5 mmol/l
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start30 Jun 2022
- Primary completion2 Feb 2024 (estimated)
- Study completion2 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will recruit 40 participants suffering from type-1 diabetes, split across 2 groups, with 30 needed for statistical significance (10 extra to allow for dropouts). The participant will have their average HbA1c levels measured (lab based, CONTROL-1)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- LovedBy LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217953
- Sponsor's protocol ID
- B01038
- Acronym
- LBY-T1
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Cross-over Design Efficacy Study to Assess the Effectiveness of App-based, Assisted Behavioural Change Techniques to Improve HbA1c Levels and Support Diabetes Self-management in Young Adults and Adolescents
- ClinicalTrials.gov ID
- NCT05217953
- Acronym / sponsor ID
- LBY-T1 / B01038
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- LovedBy LTD
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 2 Feb 2024 (estimated)
- Study completion
- 2 Feb 2024 (estimated)
- First posted
- 1 Feb 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.
Young people (16-25) with type-1 diabetes have historically struggled with managing their condition. Typically, the average HbA1c levels are significantly higher and as such, the risk of long term complications tend to be far greater.
These sufferers tend to have better management of their condition as they grow older however, the evidence suggests this is too late and these sufferers will likely have some complications later in life. Current cost to the NHS for complications is ~£850 million and expected to rise to ~£1.3 billion in the next 10-15 years.
The LovedBy solution aims to leverage modern technologies such as smartphones, continuous glucose monitors (CGM), and other smart wearables to assist young sufferers managing their condition. The LovedBy platform offers a mobile application which connects to the user's smart wearables and CGM to monitor data streams that have been linked to long term risk. The mobile application is then able to deliver personally relevant educational content to the user through numerous channels including private social media messages.
The study will last 10 months, and the participants are required to download/install the mobile app, integrate their wearables and then simply continue as normal with regular clinical meetings. Participants will be between 16-25 years and comply with the inclusion criteria set out in the protocol.
Detailed description
This study will recruit 40 participants suffering from type-1 diabetes, split across 2 groups, with 30 needed for statistical significance (10 extra to allow for dropouts). The participant will have their average HbA1c levels measured (lab based, CONTROL-1). While the participants are participating in the trial, they will receive relevant educational content based on areas of management they are struggling with. The analysis that decides this is automated by the system which explores whether the particular criteria have been met for each educational pieces.
At the end of the study we will be able to compare whether the primary outcome has been met by comparing a final average HbA1c measure to CONTROL-1. Secondary outcomes can be evaluated using the sensor HbA1c recordings.
The entire study can be summarised as a reference to a reduction in long term risk and cost saving to the NHS.
Participant Journey
Pre-Trial (Visit 1):
1-3 hours 2-4 weeks before study starts Firstly, the patient will be sent all relevant study documents after which there is the recruitment call where the study will be described in detail. All risks will be discussed here and made clear. The data policies and management of data will also be described here. The patient will be able to ask any questions they wish to do so at this point.
If the patient is willing to participate in the trial, consent will be obtained after the they have had adequate time to reflect on the study.
Once consent has been obtained, the participant will be able to undergo lab HbA1c sampling. The participant will also undertake a questionnaire (Diabetes Distress Scale). The questionnaire will be undertaken at intervals between the other tasks during this visit.
Trial (Visit-2):
1-2 hours Study starts The clinical research team (CRT) will collect various measures such as weight, height blood pressure, body fat etc.and also ensure the users CGM is set up correctly.
Test-Group: The CGM will be integrated with the users mobile handset and all relevant measures taken will be entered. Participant will be provided with a smart watch and this will also be integrated with the users smartphone.
The user will then download and install the LovedBy mobile app. Once installed the user will set up an account and the account number will be recorded by the clinical research team to track the participant throughout the trial. The final step is to review the permissions of the mobile application and allow the mobile application to connect to the users handset. Control-Group: The same measurements will be taken as with the test group but here no app will be provided to the participants in this group.
Trial (Visit-3):
1-2 hours 8-weeks since last visit Test-Group: Participants of this group will undergo an interview with clinical research team. They will discuss events that were identified by the LovedBy platform. The CRT will also update the measures taken in the previous visit. The participant will also be asked to partake in a semi-structured interview to asses phycological efficacy.
Control-Group: This group will not undergo an interview.
Trial (Visit-4):
1-2 hours 8-weeks since last visit All participants will end the first arm of the study with lab HbA1c recorded. They will then proceed with a 4-week washout period. After which they will cross-over to begin the second arm of the study.
Trial (Visit-5):
1-2 hours 4-weeks since last visit This visit will be identical to Visit-2 but the Test-Group and Control-Group will switch over.
Trial (Visit-6):
1-2 hours 8-weeks since last visit This visit will be identical to Visit-3 where only the Test-Group will be interviewed.
Trial (Visit-7):
1-2 hours 8-weeks since last visit All participant will undergo a lab HbA1c sampling. The participant will undergo an exit interview regarding their experience with and without the LovedBy app. During this exit interview all LovedBy resources provided to the user such as smartwatches, CGM and applications will be handed back and/or removed from the user's device. The interview will aim to better capture the qualitative efficacy of the platform. It will be analysed to identify areas of design improvements that can be made on the user interface and content pieces.
Study Complete (Correspondence):
The participants will be provided the results of the study electronically
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will recruit 40 participants suffering from type-1 diabetes, split across 2 groups, with 30 needed for statistical significance (10 extra to allow for dropouts). The participant will have their average HbA1c levels measured (lab based, CONTROL-1)
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: LovedBy AppThe CGM will be integrated with the users mobile handset and all relevant measures taken will be entered. Participant will be provided with a smart watch and this will also be integrated with the users smartphone. The user will then download and install the LovedBy mobile app. Once installed the user will set up an account and the account number will be recorded by the clinical research team to track the participant throughout the trial. The final step is to review the permissions of the mobile application and allow the mobile application to connect to the users handset |
| Control-Group | No intervention | –The same measurements will be taken as with the test group but here no app will be provided to the participants in this group. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1. Age between 16 - 25. 2. Type 1 diabetes, as defined by World Health Organisation (WHO) for at least 1 year or is confirmed C-peptide negative. 3. HbA1c between 7.5 - 14.0% based on analysis from local laboratory or equivalent within 3 months of enrolment.
- 4. Has an Apple smartphone compatible with Dexcom G6. 5. Willingness to download the LovedBy app on their smartphone. 6. Willingness to wear an apple smartwatch. 7. Willingness to wear a Dexcom CGM. 8. Literate in English.
Key exclusion criteria (3 listed)
- 1. Non-type 1 diabetes mellitus including those secondary to chronic disease. 2. Biphasic insulin MDI pen users. 3. Any other physical or psychological disease is likely to interfere with the normal conduct of the study.
- 4. Untreated coeliac disease or hypothyroidism. 5. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers, MAO inhibitors etc.
- 6. Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement. 7. Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin disease) located at places of the body, which could potentially be used for localisation of the glucose sensor. 8. Lack of reliable telephone facility for contact. 9. Known or suspected allergy against insulin. 10. Severe visual impairment. 11. Severe hearing impairment. 12. Not proficient in English. 13. Pregnancy, or planning for pregnancy.
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 |
|---|---|---|
| LovedBy AppThe LovedBy solution aims to leverage modern technologies such as smartphones, continuous glucose monitors (CGM), and other smart wearables to assist young sufferers managing their condition. The LovedBy platform offers a mobile application which connects to the user's smart wearables and CGM to monitor data streams that have been linked to long term risk. The mobile application is then able to deliver personally relevant educational content to the user through numerous channels including private social media message | Device | Test Group |
Primary outcome
Change in HbA1c
Time frame: 4 months
primary objective is to assess change in HbA1c change at 4 months following use of the LovedBy digital solution and 4 months without the the LovedBy app. (Lab based measures.)
7 secondary outcomes
Time spent below target glucose (3.9 mmol/l)
Time frame: 10 months
Time spent above target glucose (10.0 mmol/l)
Time frame: 10 months
Average, standard deviation, and coefficient of variation of glucose levels
Time frame: 10 months
The time with glucose levels in hypoglycaemia at <3.5 mmol/l and <2.8 mmol/l
Time frame: 10 months
The time with glucose levels in significant hyperglycaemia (>16.7 mmol/l)
Time frame: 10 months
Total, basal and bolus insulin dose
Time frame: 10 months
AUC of glucose below 3.5 mmol/l
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Manchester University NHS Foundation Trust
Manchester, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LovedBy App in people with Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2023.