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Intensive glycemic control in adults aged 80 years and older: A randomized trial evaluating diabetes complications and competing mortality

In brief

Intensive glucose control in 80+ adults raises severe hypoglycemia sevenfold, no vascular benefit

In a 5-year randomized trial of 206 independently ambulatory seniors with type 2 diabetes, targeting HbA1c < 7% lowered average HbA1c but did not reduce micro- or macrovascular events compared with a target < 9%. Hospitalized severe hypoglycemia occurred in seven participants versus one in the conservative group, highlighting limited benefit and higher risk in this age group.

Journal
Diabetes research and clinical practice (Q1)
Published
3 August 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Jin-Han Yang, Yun-Kai Yeh, Harn-Shen Chen
PMID
42546974
DOI
10.1016/j.diabres.2026.113483

Why clinicians should know about it

Abstract

AIMS: To evaluate whether intensive glycemic control reduces microvascular or macrovascular events compared with conservative glycemic targets in independently ambulatory adults aged 80 years or older with type 2 diabetes. METHODS: We conducted a prospective, randomized, open-label, single-center trial enrolling independently ambulatory adults aged ≥ 80 years with type 2 diabetes. Participants were assigned (1:1) to an intensive glycemic target (HbA1c < 7 %) or a conservative target (HbA1c < 9 %) and followed for 5 years. Primary outcomes were composite microvascular and macrovascular events. Analyses were done by intention to treat. Cause-specific Cox models and Fine-Gray subdistribution hazard models were used to account for all-cause mortality as a competing event. This trial is registered with ClinicalTrials.gov, NCT00850798. FINDINGS: 206 participants were randomly assigned to intensive (n = 102) or conservative (n = 104) treatment. At 5 years, mean HbA1c was lower in the intensive group than in the conservative group (7·42 % vs 8·21 %; p = 0·005). Intensive therapy did not reduce microvascular events (hazard ratio [HR] 1·24, 95 % CI 0·76-2·04) or macrovascular events (HR 1·02, 0·36-2·92). Competing risk analyses showed no reduction in cumulative incidence of vascular outcomes (subdistribution HR approximately 1·0 for both). The cumulative incidence of death exceeded that of vascular events, indicating that many participants died before potential glycemic benefits could be realized. Severe hypoglycemia requiring hospitalization was more frequent with intensive therapy (7 vs 1 event). INTERPRETATION: In adults aged 80 years or older with type 2 diabetes, intensive glycaemic control improved glycaemic levels but did not reduce vascular events and increased the risk of severe hypoglycaemia. High competing mortality substantially limits the potential long-term benefit of intensive treatment, supporting conservative and individualized glycemic targets in very old adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00850798.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.