Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a feasibility study, recruiting older adults (aged 65 years and older) with type 2 diabetes, living in care homes who are suitable for de-intensification of medications.
Participants will be
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 65 years or older 2. Confirmed diagnosis of type 2 diabetes 3. Currently on tablets for diabetes control, non-insulin injectable glucose-lowering therapies, insulin or any combination of these treatments 4. HbA1c less than 7.5% (58 mmol/mol) in the previous 12 months prior to the baseline search 5. Currently living in a care home setting (residential, nursing or mixed) 6. Participant is willing and able to give informed consent for participation OR if the participant lacks capacity, a consultee is willing to complete a consultee declaration form
Exclusion criteria
Exclusion criteria: 1. No confirmed diagnosis of type 2 diabetes 2. No diabetes medication issued in the 3 months before the database search for eligible participants 3. Aged 64 years old and younger 4. Last HbA1C reading >=7.5% (58 mmol/mol) in the previous 12 months prior to the baseline search 5. Participant has opted out of sharing their personal data as part of the national data opt-out policy 6. Receiving end-of-life care 7. Currently participating in a CTIMP study, or has participated in a CTIMP in the last 30 days 8. Is a temporary care home resident (i.e. less than 1 month of planned transitional/respite residential care) 9. Planning to travel away from the care home for >=2 weeks (on holiday, for example)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participants achieving a composite of more than 50% time in range and less than 1% time below range, during the 12-week follow-up period. Measured via CGM continuously across the 12-week study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants, during the 12-week follow-up period, with any of the following outcomes: 1. Quality of life measured using the EQ-5D-5L at baseline and 12 weeks 2. Self-reported hypoglycaemic-related adverse events measured via a diary/log throughout the 12-week study 3. Self-reported hyperglycaemic-related adverse events measured via a diary/log throughout the 12-week study 4. Emergency hospital admissions for hypoglycaemic-related events, extracted from medical records and reviewed during the medication reviews (weeks, 2, 4 and 8) and at 12 weeks 5. Emergency hospital admissions for hyperglycaemic-related events extracted from medical records and reviewed during the medication reviews (weeks, 2, 4 and 8) and at 12 weeks 6. Death, extracted from medical records throughout the 12-week study The following will be measured by extracting the data from the Dexcom One+ device (the Dexcom ONE+ collects data continuously, so these variables are measured throughout the 12-week study): 1. The change in “time above ranges” - time spent above 10 mmol/l and 13.9 mmol/l 2. The change in “time below ranges” - time below 3.9 mmol/l and 3.0 mmol/l 3. The percentage of participants recording a 4-hour sustained glucose reading >18 mmol/l at least once 4. Adherence to the Dexcom One+ sensor programme 5. The frequency of technical problems reported on a log/diary throughout the 12-week study 1. The acceptability of the study device by participants, their consultee (if applicable) and care home staff will be assessed using the Theoretical Framework of Acceptability questionnaire at week 12 | — |
Countries
United Kingdom
Outcome results
None listed