Last updated: March 1, 2023
Sponsor: Manchester University NHS Foundation Trust
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Prevention
Diabetes And Hypertension
Diabetes Mellitus, Type 1
Treatment
N/AClinical Study ID
NCT05217953
B01038
Ages 16-25 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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% basedon analysis from local laboratory or equivalent within 3 months of enrolment.
- Has an Apple smartphone compatible with Dexcom G6. 5. Willingness to download theLovedBy app on their smartphone. 6. Willingness to wear an apple smartwatch. 7. Willingnessto wear a Dexcom CGM. 8. Literate in English.
Exclusion
Exclusion Criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease. 2.Biphasic insulin MDI pen users. 3. Any other physical or psychological disease islikely to interfere with the normal conduct of the study.
- Untreated coeliac disease or hypothyroidism. 5. Current treatment with drugs knownto interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2inhibitors, GLP-1 agonists, non-selective beta-blockers, MAO inhibitors etc.
- Medically documented allergy towards the adhesive (glue) of plasters or unable totolerate 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 couldpotentially be used for localisation of the glucose sensor. 8. Lack of reliabletelephone facility for contact. 9. Known or suspected allergy against insulin. 10.Severe visual impairment. 11. Severe hearing impairment. 12. Not proficient inEnglish. 13. Pregnancy, or planning for pregnancy.
Study Design
Total Participants: 40
Study Start date:
June 30, 2022
Estimated Completion Date:
February 02, 2024
Study Description
Connect with a study center
Manchester University NHS Foundation Trust
Manchester, M139WL
United KingdomActive - Recruiting
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