This study aims to compare the effect of flash glucose monitoring (FGM) with traditional self-monitoring of blood glucose (SMBG) with or without carbohydrate counting and automated bolus calculation, in patients with type 1 diabetes and poor metabolic control. The investigators will include in total 200 patients recruited from 5 clinical sites in the Capital Region of Copenhagen. The patients will be randomized into four groups; A) Standard diabetes training, i.e. group training in in general diabetes health issues, B) Group training in carbohydrate counting and automated bolus calculation, the app MySugr will be taught and downloaded, C) Group training as in group A, and instructed to use FGM, D) Group training as in group B, and besides training in the use of the app MySugr, also instructed to use FGM. All patients are followed for 26 weeks with 6 clinical visits, group training (1 visit) and 2 telephone consultations. The primary outcome is time spent in normoglycemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
184
Group training in carbohydrate counting and bolus calculation. The app MySugr will be taught and downloaded on own smart phone and person specific parameters will be estimated and entered in the app with the patients. SMBG measures at least 4 times daily with patients own preferred glucose meter.
Group training, patients will be instructed to use unblinded FGM for the whole study period. Patients are recommended to measure SMBG according to FGM manufactures guideline and handling of trend arrows etc.
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Time in normoglycemia
Difference in time in normoglycemic range 4-10 mmol/l at end of study measured by 2 weeks blinded FGM between group A (control group) and C (FGM) (min/day).
Time frame: 26 weeks
HbA1c
Difference among groups in change in HbA1c (mmol/mol).
Time frame: 26 weeks
Severe hypoglycemia
Difference among groups in occurrence of severe hypoglycemia (defined as an event requiring assistance of another person. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal) (number of events during study period).
Time frame: 26 weeks
Hypoglycemia
Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (\< 3 mmol/l) (number of episodes per week).
Time frame: 26 weeks
Diabetes distress
Difference in changes in diabetes distress by the use of Problem Areas in Diabetes Questionnaire (PAID, score 0-100; higher scores reflecting diabetes distress).
Time frame: 26 weeks
Diabetes treatment satisfaction
Difference in changes in treatment satisfaction by the use of Diabetes Treatment Satisfaction Questionnaire (DTSQ, score 0-36; higher scores reflecting higher satisfaction).
Time frame: 26 weeks
Diabetes empowerment
Difference in changes in empowerment by the use of Diabetes empowerment test (DES-short form, containing 8 items, higher scores reflecting diabetes-related psychosocial self-efficacy. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point, and an overall score is calculated by adding all of the scores (8-40) and dividing by the number of completed items (highest number is 8)).
Time frame: 26 weeks
Diabetes quality of life
Difference in changes in life quality by the use of Diabetes quality of life (ADDQoL-19, scores -9-3, lower scores reflecting maximum negative impact).
Time frame: 26 weeks
Blinded FGM hypoglycemia
Difference in change in time spent in hypoglycemia (\<3mmol/l, \<4 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Time frame: 26 weeks
Blinded FGM hyperglycemia
Difference in change in time spent in hyperglycemia (\>10 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Time frame: 26 weeks
Blinded FGM glycemic variability
Difference in change in glycemic variability (standard deviation) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Time frame: 26 weeks
Personality traits
Association between personality traits evaluated by the use of Neuroticism Extraversion Openness Agreeableness Conscientiousness Five-Factor Inventory-3 (NEO-Five Factors Inventory-3) questionnaire and any other outcome measures in the different groups. The NEO-Five Factors Inventory-3 covers five factors/domains that describe the commonly accepted personality traits. The inventory contains 60 statements that should be evaluated by self-ratings on a 5-point scale where 1 reflects "strongly disagree" and 5 reflects "strongly agree". The answers are related to the norm and based on these scores, personality traits are reported by the internet based Hogrefe Testsystem 5 (Hogrefe Publishing Group).
Time frame: 26 weeks
Total insulin dose
Difference in change between the groups in total insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Time frame: 26 weeks
Total basal insulin dose
Difference in change between the groups in total basal insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Time frame: 26 weeks
Insulin boluses
Difference in change between the groups in number of insulin boluses per day (number/day) recorded as a mean of 2 weeks during FGM blinded measurements.
Time frame: 26 weeks
Body weight
Difference among groups in body weight (kg).
Time frame: 26 weeks
Urinary albumin/excretion rate
Difference among groups in urinary albumin/excretion rate (mg/24 hours).
Time frame: 26 weeks
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