Initiation and management of DExcom continuous glucose monitoring in primary care in people living with type 2 diabetes on insulin

Approved 02/03/2026, East of Scotland Research Ethics Service (EoSRES) (TAyside medical Science Centre , Residency Block Level 3 , George Pirie Way , Ninewells Hospital and Medical School, Dundee, DD1 9SY, United Kingdom; +44 01382 660111; tay.eosres@nhs.scot), ref: 25/ES/0116

1. HbA1c level measured using data collected from CGM (cohort 1) compared with retrospective data from local laboratory testing (cohort 2) at continuous versus retrospective time points between baseline and week 24

1. HbA1c level measured using data collected from CGM (cohort 1) compared with retrospective data from local laboratory testing (cohort 2) at continuous versus retrospective time points between baseline and week 12
2. HbA1c levels: ≥69 mmol/mol (≥8.5%), ≥75 mmol/mol (≥9.0%), ≥80 mmol/mol (≥9.5%), ≥86 mmol/mol (≥10.0%), stratified by baseline HbA1c measured using data collected from CGM (cohort 1) compared with retrospective data from local laboratory testing (cohort 2) at continuous versus retrospective time points between baseline and weeks 12 and 24
3. HbA1c thresholds, defined as the percent participants reaching HbA1c ≤53 mmol/mol (≤7.0%), percent participants reaching target HbA1c of ≤58 mmol/mol (≤7.5%), percent participants decreasing HbA1c by ≥0.5%, percent participants reaching HbA1c 7% and/or decreasing by 0.5% measured using data collected from CGM (cohort 1) compared with retrospective data from local laboratory testing (cohort 2) at weeks 12 and 24
4. CGM-derived metrics measured using CGM-determined percent of time in range (TIR) (3.9-10.0 mmol/L), CGM-determined percent of time in tight range (TITR) (3.9-7.8 mmol/L), CGM- determined glucose management indicator (GMI), CGM-determined mean glucose, CGM-determined glucose variability (coefficient of variation (CV) and standard deviation (SD)), CGM-determined percent of time above range (TAR) level 1 (>10.0 mmol/L and ≤13.9 mmol/L), CGM-determined percent time >10.0 mmol/L, CGM-determined percent TAR level 2 (>13.9 mmol/L), CGM-determined percent time >16.7 mmol/L, CGM-determined time below range (TBR) level 1 (<3.9 mmol/L and ≥3.0 mmol/L), CGM-determined percent <3.9 mmol/L, CGM-determined percent TBR level 2 (<3.0 mmol/L), CGM- determined low glucose episodes (defined as glucose values detected by CGM of <3.0 mmol/L for at least 15 minutes, preceded by minimum of 30 minutes of glucose values >3.0 mmol/L from baseline at baseline to weeks 12 and 24 (over 24 hours and daytime and nighttime individually)
5. CGM-derived thresholds measured using percent participants increasing TIR by ≥5%, percent participants with TIR ≥70% at weeks 12 and 24
6. Primary care workflow and resource use measured using change in primary care resource utilisation from baseline to scheduled visits: the number of primary care visits (overall and for diabetes management individually); number of referrals to secondary/specialist care; change in medication and consumables (e.g. test strips), baseline data will be retrospectively collected from the previous 6 months at time of screening, time required for HCP to set up participants with CGM at initiation, percent of participants who need additional support from primary care HCP following initiation to set up and to be started on CGM at the previous 6 months at time of screening and from baseline to scheduled visits
7. Combined glycaemic control and primary care resource use outcomes measured using percent participants at week 24 decreasing HbA1c by ≥0.5% AND attended ≤ same number of primary care visits during the intervention as 6 months prior (collected retrospectively), percent participants at week 24 increasing TIR ≥5% AND attended ≤ same number of primary visits during the intervention as 6 months prior at week 24 and at 6 months prior (collected retrospectively)
8. Body weight measured using standard measurements and retrospective data at baseline, 12 and 24 weeks
9. Body mass index (BMI) measured using standard measurements and retrospective data at baseline, 12 and 24 weeks
10. Daily insulin dose/kg body weight (bolus and basal) measured using change in daily insulin dose/kg body weight (bolus and basal) at baseline to 12 and 24 weeks
11. Blood lipids (CHOL, TRG, HDL, LDL) measured using change in blood lipids (CHOL, TRG, HDL, LDL) at baseline to 12 and 24 weeks
12. Estimated cardiovascular disease risk measured using change in estimated cardiovascular disease risk at baseline to 12 and 24 weeks
13. Total medication use (adding or removing medications, dose changes) measured using data from medical records at baseline, 12 and 24 weeks
14. Secondary care healthcare resource utilisation (number of hospitalizations (total and split by reason), outpatient visits, and tests measured using data from medical records at 24 weeks prior to screening (historical data collected retrospectively) to 24 weeks.
15. Status and changes in psychosocial and behavioural aspects of diabetes measured using patient-reported outcome measures and in participant qualitative interviews at study completion