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

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Jan 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help young adults and adolescents, aged 16 to 25, manage their type 1 diabetes better. The goal is to improve their HbA1c levels, which is a measure of blood sugar control over time. Many young people with type 1 diabetes struggle to manage their condition, leading to higher risks of complications later in life. The trial will use a mobile app called LovedBy, which connects to devices like continuous glucose monitors (CGMs) and smartwatches. This app will provide personalized tips and educational content to help participants manage their diabetes more effectively.

To join the trial, participants need to be between 16 and 25 years old, have type 1 diabetes for at least one year, and have an HbA1c level between 7.5% and 14%. They will also need to have an Apple smartphone and be willing to use the LovedBy app and wear a smartwatch and CGM. The study will last for 10 months, and participants will continue to meet regularly with their healthcare providers while using the app. This trial not only aims to improve diabetes management but also hopes to reduce the long-term costs associated with diabetes-related complications.

Gender

ALL

Eligibility criteria

• 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.