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A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed. A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM. The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires. The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
NU-Hosptial Group
Uddevalla, Sweden
Start Date
November 1, 2018
Primary Completion Date
December 30, 2023
Completion Date
December 31, 2023
Last Updated
April 18, 2024
117
ACTUAL participants
systematic intensive therapy
OTHER
Lead Sponsor
Vastra Gotaland Region
NCT05054361
NCT06753994
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05061030