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. 2018 Feb 5;19(1):91.
doi: 10.1186/s13063-018-2479-9.

Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial

Melanie Schipfer  1 , Carmen Albrecht  2 , Dominic Ehrmann  2 , Thomas Haak  3 , Bernd Kulzer  2 , Norbert Hermanns  2
Affiliations

Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial

Melanie Schipfer et al. Trials. .

Abstract

Background: People with diabetes on intensive insulin therapy need sufficient glycaemic control to prevent the onset or progression of diabetic complications. The burden of multiple daily blood glucose self-testing can be lessened by novel diabetes technology like flash glucose monitoring systems which provide more information compared to self-monitoring of blood glucose. Despite this delivered additional information studies are showing no significant effect on HbA1c reduction, but a reduced time spent in a hypoglycaemic glucose range. We assume that users of these devices need additional education and training to integrate the delivered information into treatment decisions. Therefore, FLASH, an education and treatment programme, was developed. The programme evaluation follows herein.

Methods/design: Patients are recruited through 40 diabetes outpatient study centres located across Germany. They will be randomly assigned to participate in the education and treatment programme (intervention group) or to obtain treatment as usual (control group). All patients have to give blood samples and to answer a bench of questionnaires during baseline assessment, at the end of the intervention, and 6 months after the end of the intervention. Physicians will be asked to declare some additional clinical data (such as details of the diabetes therapy) for every patient at every one of the three assessment points.

Discussion: This study is conducted as a randomised controlled trial to test the hypothesis that the newly developed education and treatment programme combined with the use of a flash glucose monitoring device (intervention group) is superior to reduce HbA1c compared to the use of flash glucose monitoring alone (control group). The first results will be expected in 2018.

Trial registration: ClinicalTrials.gov, ID: NCT03175315 . Registered on 2 May 2017.

Keywords: Diabetes; Flash glucose monitoring; Patient education and treatment programme; Patient-reported outcome; Psychoeducation; Self-management.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Ethics Committee of the German Psychological Association (reference number NH032107). Ethical approval was received on 25 April 2017. All patients will have to provide signed informed consent before inclusion in the study. There are no plans for protocol modification.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have competing interests.

MS received speakers’ honoraria from Medtronic and Lilly Diabetes Germany.

CA has no conflict of interest.

DE received speakers’ honoraria from Berlin Chemie AG and Roche Diabetes Care.

TH is an advisory board member of Roche Diabetes Care, Sanofi, and Lilly. He received speakers’ honoraria from Berlin Chemie AG, Lilly, and AstraZeneca.

BK is an advisory board member of Berlin Chemie AG, Roche Diabetes Care, Novo Nordisk, Medtronic, and Ascensia Diabetes Care. He received speakers’ honoraria from Berlin Chemie AG, Novo Nordisk, Roche Diabetes Care, Abbott, Lilly, and Ascensia Diabetes Care. He has received grants in support of investigator trials from Berlin Chemie AG, Abbott, and Roche Diabetes Care.

NH is an advisory board member of Novo Nordisk, Abbott, Lilly, Roche Diabetes Care, and Ypsomed. He received speakers’ honoraria from Novo Nordisk, Abbott, Berlin Chemie AG, Lilly, and Ypsomed. He has received grants in support of investigator trials from Dexcom, Berlin Chemie AG, Ypsomed, Abbott, and Roche Diabetes Care.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The evaluation of FLASH – study flowchart
Fig. 2
Fig. 2
Overview of all measurements at the different assessment points
See this image and copyright information in PMC

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