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| Name | Class |
|---|---|
| Hillerod Hospital, Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Bispebjerg Hospital | OTHER |
| Rigshospitalet, Denmark |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) Standard diabetes training (control) | No Intervention | More specifically, group training in general diabetes health issues, how to do experienced based dosing, how to handle sick days, exercise etc. in general terms. The group will not be taught in carbohydrate counting or bolus calculation. They will be encouraged to measure SMBG at least 4 times daily with patients own preferred glucose meter. Patients will be offered 6 months treatment with FGM after study end. | |
| B) Carbohydrate counting, automated bolus calculation | Active Comparator |
| |
| C) Flash glucose monitoring (FGM) | Active Comparator | Group training with same content as for group A. |
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| D) Carbohydrate counting, automated bolus calculation, FGM | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate counting, automated bolus calculation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Difference among groups in change in HbA1c (mmol/mol). | 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). |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34495375 | Derived | Secher AL, Pedersen-Bjergaard U, Svendsen OL, Gade-Rasmussen B, Almdal T, Raimond L, Vistisen D, Norgaard K. Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections: a 26 week randomised, controlled, multicentre trial. Diabetologia. 2021 Dec;64(12):2713-2724. doi: 10.1007/s00125-021-05555-8. Epub 2021 Sep 8. | |
| 32345699 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Frederiksberg University Hospital | OTHER |
| Amager Hospital | OTHER |
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| Flash glucose monitoring (FGM) | Device | 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. |
|
| 26 weeks |
| Hypoglycemia | Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (< 3 mmol/l) (number of episodes per week). | 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). | 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). | 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)). | 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). | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 26 weeks |
| Body weight | Difference among groups in body weight (kg). | 26 weeks |
| Urinary albumin/excretion rate | Difference among groups in urinary albumin/excretion rate (mg/24 hours). | 26 weeks |
| Derived |
| Secher AL, Pedersen-Bjergaard U, Svendsen OL, Gade-Rasmussen B, Almdal TP, Dorflinger L, Vistisen D, Norgaard K. Study protocol for optimising glycaemic control in type 1 diabetes treated with multiple daily insulin injections: intermittently scanned continuous glucose monitoring, carbohydrate counting with automated bolus calculation, or both? A randomised controlled trial. BMJ Open. 2020 Apr 27;10(4):e036474. doi: 10.1136/bmjopen-2019-036474. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |