Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial.

Martens T, et al. · 2021

PubMed 34077499 ↗DOI: 10.1001/jama.2021.7444JAMA

🌱 La lettura di LEO

📉 Lavora su: Stabilità nel tempo · lente Traiettoria · il corpo nel tempo

RCT (prova forte)

La domanda

Nel diabete tipo 2 trattato con sola insulina basale (senza insulina ai pasti) in medicina generale, il monitoraggio continuo del glucosio (CGM) migliora il controllo glicemico rispetto al glucometro tradizionale?

Cosa hanno trovato

RCT multicentrico USA (15 centri), 175 adulti randomizzati 2:1 a CGM (n=116) vs glucometro/BGM (n=59); età media 57 anni, HbA1c basale 9,1%, 53% da minoranze etniche; 94% ha completato lo studio. Esito primario HbA1c a 8 mesi: scesa da 9,1% a 8,0% con CGM vs da 9,0% a 8,4% con BGM, differenza aggiustata -0,4% (IC 95% da -0,8 a -0,1; P=0,02). Tempo nel range 70-180 mg/dL: 59% vs 43% (differenza aggiustata +15%; IC 95% 8-23; P<0,001). Tempo >250 mg/dL: 11% vs 27% (differenza -16%; IC 95% da -21 a -11; P<0,001). Glucosio medio: 179 vs 206 mg/dL (differenza -26; IC 95% da -41 a -12; P<0,001). Ipoglicemia severa: 1 evento (1%) con CGM, 1 (2%) con BGM.

Cosa significa per te

Riguarda specificamente il diabete tipo 2 in terapia con sola insulina basale e con controllo scadente. Prova solida (studio randomizzato) che il sensore continuo, rispetto alle punture del dito, migliora la glicemia: circa mezzo punto di HbA1c in meno e soprattutto molte piu ore al giorno nel bersaglio (da ~10 a ~14 h su 24). Il beneficio in ipoglicemia severa non è dimostrato qui (eventi troppo rari). Non è uno studio sul tipo 1. La scelta e l'impostazione della terapia insulinica restano del diabetologo; il messaggio è sullo strumento di monitoraggio.

Abstract (in lingua originale)

IMPORTANCE: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied. OBJECTIVE: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications. INTERVENTIONS: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59). MAIN OUTCOMES AND MEASURES: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months. RESULTS: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group. CONCLUSIONS AND RELEVANCE: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03566693.

💬 Chiedi a LEO di spiegartelo

Come leggerlo: è uno studio scientifico peer-reviewed. Le evidenze aiutano a capire i trend, ma un singolo studio non è una prescrizione: parlane col tuo diabetologo prima di cambiare dieta o terapia.