Norbert Hermanns1, Dominic Ehrmann2, Melanie Schipfer3, Jens Kröger4, Thomas Haak5, Bernhard Kulzer6. 1. Research Institute Diabetes Academy Mergentheim (FIDAM), Johann-Hammer-Str. 24, 97980 Bad Mergentheim, Germany; Department of Clinical Psychology and Psychotherapy, University of Bamberg, Markusplatz 3, 96047 Bamberg, Germany; Diabetes Clinic Mergentheim, Theodor-Klotzbuecher-Str. 12, 97980 Bad Mergentheim, Germany. Electronic address: hermanns@fidam.de. 2. Research Institute Diabetes Academy Mergentheim (FIDAM), Johann-Hammer-Str. 24, 97980 Bad Mergentheim, Germany; Department of Clinical Psychology and Psychotherapy, University of Bamberg, Markusplatz 3, 96047 Bamberg, Germany. 3. Profusa, Inc., 345 Allerton Ave, South San Francisco, CA 94080, USA. 4. Centre of Diabetology Hamburg Bergedorf, Hamburg, Germany. 5. Diabetes Clinic Mergentheim, Theodor-Klotzbuecher-Str. 12, 97980 Bad Mergentheim, Germany. 6. Research Institute Diabetes Academy Mergentheim (FIDAM), Johann-Hammer-Str. 24, 97980 Bad Mergentheim, Germany; Department of Clinical Psychology and Psychotherapy, University of Bamberg, Markusplatz 3, 96047 Bamberg, Germany; Diabetes Clinic Mergentheim, Theodor-Klotzbuecher-Str. 12, 97980 Bad Mergentheim, Germany.
Abstract
AIMS: Flash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment. METHODS: We report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16-75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures. RESULTS: At six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (-0.28%, 95% CI -0.16% to -0.40% vs.-0.11%, 95% CI 0.00% to -0.22%; with a between-group difference of -0.17%, 95% CI -0.01% to -0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing. CONCLUSION:FLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM. The study was registered in ClinicalTrials: NCT03175315.
RCT Entities:
AIMS: Flash sensor-based glucose monitoring (FSGM) provides people with diabetes considerably more information on their glycaemic control. We have developed and evaluated a structured education and treatment programme, termed FLASH, to assist FSGM users to understand and use the available glycaemic information for optimization of their diabetes treatment. METHODS: We report on a multi-centre, randomized, parallel trial with a six-month follow-up involving 216 eligible participants (16-75 years old) on intensive insulin therapy. The primary outcome was HbA1c change from baseline to six months. Secondary outcomes were measures of glucose control as assessed by FSGM, as well as changes in behavioural and psychosocial measures. RESULTS: At six months, the between-group difference in HbA1c reduction was significant, favouring FLASH education compared to the control group receiving no FLASH education (-0.28%, 95% CI -0.16% to -0.40% vs.-0.11%, 95% CI 0.00% to -0.22%; with a between-group difference of -0.17%, 95% CI -0.01% to -0.33%; p = 0.033). Participation in FLASH education also resulted in significant improvements in time spent in the target glucose range, in diabetes-related distress scores and in satisfaction with the glucose monitoring method. FLASH education also resulted in significant improvements in the use of glycaemic information provided by FSGM and in reduced self-monitoring of blood glucose (SMBG) fingerstick testing. CONCLUSION: FLASH is an effective programme to improve glycaemic control and lower diabetes-related distress in users of FSGM. The study was registered in ClinicalTrials: NCT03175315.
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