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Diabet Med. 2022 Jan 13;e14791. doi: 10.1111/dme.14791. Epub 2022 Jan 13.

Randomized Controlled Study to Evaluate the Impact of Flexible Patient-controlled Visits in People with Type 1 Diabetes: The DiabetesFlex Trial.

Diabetic medicine : a journal of the British Diabetic Association

Tinne Laurberg, Liv Marit Valen Schougaard, Niels Henrik Ingvar Hjollund, Kirsten Elisabeth Lomborg, Troels Krarup Hansen, Annesofie Lunde Jensen

Affiliations

  1. Steno Diabetes Centre Aarhus, Aarhus University Hospital, Denmark.
  2. AmbuFlex, Center for Patient-Reported Outcomes, Regional Hospital West Jutland, Herning, Denmark.
  3. ResCenPI - Research Centre for Patient Involvement, Aarhus University and the Central Denmark Region, Denmark.
  4. Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
  5. Department of Clinical Medicine, Aarhus University, Denmark.
  6. Steno Diabetes Centre Copenhagen, Denmark.

PMID: 35028992 DOI: 10.1111/dme.14791

Abstract

AIM: The objective of this study was to assess the impact of health care-initiated visits versus patient-controlled flexible visits on clinical and patient-reported outcomes in people with type 1 diabetes.

METHODS: The DiabetesFlex trial was a randomized controlled, pragmatic non-inferiority 15-month follow-up study comparing standard care (face-to-face visits every four months) with DiabetesFlex (patient-controlled flexible visits using patient-reported outcomes-based telehealth follow-up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA

RESULTS: The adjusted mean difference in HbA

CONCLUSION: Compared with standard care, flexible patient-controlled visits combined with patient-reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well-being further improved diabetes-related well-being and decreased face-to-face visits while maintaining safe diabetes management.

This article is protected by copyright. All rights reserved.

Keywords: diabetes mellitus type 1; disease management; patient participation; patient-initiated and patient-controlled; patient-reported outcome measures; randomized controlled trial

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