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 (LBY-T1)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: LovedBy App

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M139WL
    • Recruiting
    • Manchester University NHS Foundation Trust
    • Contact: Hood Thabit, MD, PhD; Phone Number: 01612766102; Email: Hood.Thabit@mft.nhs.uk
    • Contact: Mohammed Nazir, BSc; Phone Number: 01612766102; Email: mohammed.nazir@mft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: LovedBy App; 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent below target glucose (3.9 mmol/l)	Time spent below target glucose (3.9 mmol/l)	10 months
Time spent above target glucose (10.0 mmol/l)	Time spent above target glucose (10.0 mmol/l)	10 months
Average, standard deviation, and coefficient of variation of glucose levels	Average, standard deviation, and coefficient of variation of glucose levels	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	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)	10 months
Total, basal and bolus insulin dose	Total, basal and bolus insulin dose	10 months
AUC of glucose below 3.5 mmol/l	AUC of glucose below 3.5 mmol/l	10 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: LovedBy LTD

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Anticipated): February 2, 2024
• Study Completion (Anticipated): February 2, 2024

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: B01038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No