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)
Diabetes Mellitus, Type 1
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 1
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.
Sites / Locations
- Manchester University NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Test Group
Control-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
The same measurements will be taken as with the test group but here no app will be provided to the participants in this group.