Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications

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Strain , W D & Paldánius , P M 2020 , ' Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications ' , Diabetes Research and Clinical Practice , vol. 166 , 108310 . https://doi.org/10.1016/j.diabres.2020.108310

Title: Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications
Author: Strain, William David; Paldánius, Päivi Maria
Contributor: University of Helsinki, Children's Hospital
Date: 2020-08
Language: eng
Number of pages: 6
Belongs to series: Diabetes Research and Clinical Practice
ISSN: 0168-8227
URI: http://hdl.handle.net/10138/332452
Abstract: Aim: Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required. Methods: We compared improvement in glycaemic control in a pooled set of people assigned to the "placebo" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated. Results: The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between-0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months. Conclusions: Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities. (C) 2020 Elsevier B.V. All rights reserved.
Subject: 3121 General medicine, internal medicine and other clinical medicine
Chronic kidney disease
Clinical inertia
Placebo effect
Randomised controlled trials
Type 2 diabetes mellitus
TREATMENT INTENSIFICATION
POSITION STATEMENT
ELDERLY-PATIENTS
TYPE-2
MANAGEMENT
PEOPLE
TIME
CARE
ASSOCIATION
THERAPY
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