IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non‐insulin Antihyperglycaemic ThErapy (IMMEDIATE): A randomized controlled trial

Abstract

Aim To examine the efficacy and patient satisfaction of intermittently scanned continuous glucose monitoring (isCGM) in adults using non‐insulin therapies for the management of type 2 diabetes. Materials and Methods The IMMEDIATE study was a multisite, open label, randomized controlled trial with follow‐up at 16 weeks. Adults with type 2 diabetes using at least one non‐insulin therapy, with an HbA1c of 7.5% or higher (≥ 58 mmol/mol), were randomized 1:1 to receive an isCGM device plus diabetes self‐management education (isCGM + DSME) or DSME alone. Enrolment occurred from 8 September 2020 to 24 December 2021. The primary outcome was percentage mean time in range (TIR), in the final 2‐week period, measured via blinded CGM. Results One hundred and sixteen participants were randomized (mean age, 58 years; diabetes duration, 10 years; mean HbA1c, 8.6% [70 mmol/mol]). At 16 weeks of follow‐up, the isCGM and DSME arm had a significantly greater mean TIR by 9.9% (2.4 hours) (95% CI, −17.3% to −2.5%; P < .01), significantly less time above range by 8.1% (1.9 hours) (95% CI, 0.5% to 15.7%; P = .037), and a greater reduction in mean HbA1c by 0.3% (3 mmol/mol) (95% CI, 0% to 0.7%; P = .048) versus the DSME arm. Time below range was low and not significantly different between groups and hypoglycaemic events were few in both groups. Glucose monitoring satisfaction was higher among isCGM users (adjusted difference −0.5 [95% CI, −0.7 to −0.3], P < .01). Conclusions The IMMEDIATE study has shown that among non‐insulin–treated individuals with type 2 diabetes, use of isCGM is associated with an improvement in glycaemic outcomes.

Kontinuierliche Glukosemessung bei Menschen mit Typ-2-Diabetes ohne intensivierte Insulintherapie: eine Standortbestimmung

“…5 RCTs [24,42,43,44,45] < 0,05). Darüber hinaus sank der HbA1c-Wert in der Interventionsgruppe signifikant um 1,16 % und der BMI um 0,53 (p < 0,05) [42].…”

“…In einer offenen, randomisierten, kontrollierten, multizentrischen Studie [45] wurden 116 erwachsene Teilnehmer mit Typ-2-Diabetes, die mindestens eine nicht-insulinbasierte Therapie erhielten und einen HbA1c-Wert von 7,5 % oder höher aufwiesen, im Verhältnis 1:1 randomisiert und erhielten entweder isCGM plus Diabetes-Selbstmanagement-Schulung (isCGM + DSME) oder DSME allein. Nach einer Nachbeobachtungszeit von 16 Wochen hatte sich die mittlere TIR im isCGM-und DSME-Arm um 9,9 % (2,4 Stunden) ehöht (95 % CI, -17,3 % bis -2,5 %; P < 0).…”

An estimate of the need for continuous glucose monitoring in type 2 diabetes with intensive insulin treatment in secondary healthcare

“…The benefits of continuous glucose monitoring (CGM) in persons with type 2 diabetes (T2DM) have recently been documented in populations receiving basal insulin only, 1 basal-bolus therapy 2,3 and even in patients not receiving insulin. 4,5 The use of CGM in T2DM reduced acute diabetes complications in epidemiological studies [6][7][8][9][10] and had the potential to improve quality of life and diabetesrelated complications while reducing long-term healthcare costs. 11,12 The current clinical guidelines of the National Institute for Health and Care Excellence (NICE) recommend CGM to adults with type 2 diabetes on multiple daily insulin injections if one of the following applies: 1.…”

“…The benefits of continuous glucose monitoring (CGM) in persons with type 2 diabetes (T2DM) have recently been documented in populations receiving basal insulin only, 1 basal‐bolus therapy 2,3 and even in patients not receiving insulin 4,5 . The use of CGM in T2DM reduced acute diabetes complications in epidemiological studies 6–10 and had the potential to improve quality of life and diabetes‐related complications while reducing long‐term healthcare costs 11,12 .…”

Continuous Glucose Monitoring in Older Adults: What We Know and What We Have Yet to Learn

“…Additional studies, such as the IMMEDIATE study, support the use of CGM for improving T2DM in those with suboptimal control who are not yet on insulin and note improved TIR by 9.9% (2.4 hours) when CGM is utilized alongside diabetes education. 18…”