Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Carbohydrate counting, automated bolus calculationDevice: Flash glucose monitoring (FGM)
- Registration Number
- NCT03682237
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D) Carbohydrate counting, automated bolus calculation, FGM Carbohydrate counting, automated bolus calculation Group training as group B. A more sophisticated education concept will be developed for how FGM should be used to adjust settings and suggestions from the automated bolus calculator (MySugr app). D) Carbohydrate counting, automated bolus calculation, FGM Flash glucose monitoring (FGM) Group training as group B. A more sophisticated education concept will be developed for how FGM should be used to adjust settings and suggestions from the automated bolus calculator (MySugr app). B) Carbohydrate counting, automated bolus calculation Carbohydrate counting, automated bolus calculation - C) Flash glucose monitoring (FGM) Flash glucose monitoring (FGM) Group training with same content as for group A.
- Primary Outcome Measures
Name Time Method Time in normoglycemia 26 weeks 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).
- Secondary Outcome Measures
Name Time Method Blinded FGM glycemic variability 26 weeks Difference in change in glycemic variability (standard deviation) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Severe hypoglycemia 26 weeks 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).
Diabetes treatment satisfaction 26 weeks Difference in changes in treatment satisfaction by the use of Diabetes Treatment Satisfaction Questionnaire (DTSQ, score 0-36; higher scores reflecting higher satisfaction).
Total insulin dose 26 weeks Difference in change between the groups in total insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Total basal insulin dose 26 weeks 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.
Hypoglycemia 26 weeks Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (\< 3 mmol/l) (number of episodes per week).
Diabetes quality of life 26 weeks 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).
HbA1c 26 weeks Difference among groups in change in HbA1c (mmol/mol).
Diabetes distress 26 weeks Difference in changes in diabetes distress by the use of Problem Areas in Diabetes Questionnaire (PAID, score 0-100; higher scores reflecting diabetes distress).
Diabetes empowerment 26 weeks 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)).
Blinded FGM hyperglycemia 26 weeks 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.
Urinary albumin/excretion rate 26 weeks Difference among groups in urinary albumin/excretion rate (mg/24 hours).
Blinded FGM hypoglycemia 26 weeks 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.
Insulin boluses 26 weeks 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.
Personality traits 26 weeks 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).
Body weight 26 weeks Difference among groups in body weight (kg).
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
🇩🇰Copenhagen, Denmark