Status:
UNKNOWN
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
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
LovedBy LTD
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
16-25 years
Phase:
NA
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 com...
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 t...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05217953
Start Date
June 30 2022
End Date
February 2 2024
Last Update
March 2 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M139WL