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

NCT05217953 | Unknown

• 1 other identifier: B01038
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time spent below target glucose (3.9 mmol/l)

  10 months

• Time spent above target glucose (10.0 mmol/l)

  10 months

• 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

  10 months

• The time with glucose levels in significant hyperglycaemia (>16.7 mmol/l)

  10 months

Study Arms (2)

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

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.

Interventions

LovedBy App DEVICE

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

Test Group

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.
• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• LovedBy LTD: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M139WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 1, 2022
• Study Start: June 30, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)