Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study
NCT ID: NCT03682237
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
184 participants
INTERVENTIONAL
2018-10-01
2020-10-26
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A) Standard diabetes training (control)
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.
No interventions assigned to this group
B) Carbohydrate counting, automated bolus calculation
Carbohydrate counting, automated bolus calculation
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.
C) Flash glucose monitoring (FGM)
Group training with same content as for group A.
Flash glucose monitoring (FGM)
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.
D) Carbohydrate counting, automated bolus calculation, 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).
Carbohydrate counting, automated bolus calculation
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.
Flash glucose monitoring (FGM)
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.
Interventions
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Carbohydrate counting, automated bolus calculation
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.
Flash glucose monitoring (FGM)
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.
Eligibility Criteria
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Inclusion Criteria
* HbA1c \> 53 mmol/mol
* Type 1 diabetes more than 1 year
* Treated with basal and bolus insulin. Basal insulin can be taken once or twice daily. The percentage basal/bolus insulin should as judged by the investigator cover the patient's real need for basal insulin - if he or she is not eating and taking bolus
* Patients may or may not have knowledge on carbohydrate counting
* Patients may or may not have any experience with continuous glucose monitoring or FGM
* Patients have a personal smart phone
* Patients attend the outpatient clinic in one of the five study sites included in the study
Exclusion Criteria
* Daily use of continuous glucose monitoring or FGM on a daily basis within the last three months
* Use of insulin pump
* Use of Neutral Protamine Hagedorn insulin as long acting insulin (Insulatard, Humulin Retard) within the last three months
* Pregnant, breastfeeding, plan to get pregnant
* Gastroparesis
* Severe diabetes complications including proliferative retinopathy and myocardial infarction within the last six months
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation as e.g. alcohol and drug abuse
* Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Inability to understand the individual information and to give informed consent
18 Years
ALL
No
Sponsors
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Hillerod Hospital, Denmark
OTHER
Hvidovre University Hospital
OTHER
Bispebjerg Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Frederiksberg University Hospital
OTHER
Amager Hospital
OTHER
Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Kirsten Nørgaard
Principal Investigator
Locations
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Steno Diabetes Center Copenhagen
Copenhagen, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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H-17040573
Identifier Type: -
Identifier Source: org_study_id