Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study
1 other identifier
interventional
184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 24, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2020
CompletedOctober 28, 2020
October 1, 2020
2.1 years
September 13, 2018
October 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (16)
HbA1c
26 weeks
Severe hypoglycemia
26 weeks
Hypoglycemia
26 weeks
Diabetes distress
26 weeks
Diabetes treatment satisfaction
26 weeks
- +11 more secondary outcomes
Study Arms (4)
A) Standard diabetes training (control)
NO INTERVENTIONMore 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 COMPARATORC) Flash glucose monitoring (FGM)
ACTIVE COMPARATORGroup training with same content as for group A.
D) Carbohydrate counting, automated bolus calculation, FGM
ACTIVE COMPARATORGroup 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age \>/= 18 years
- 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
You may not qualify if:
- Use of an automatic bolus calculator on a daily basis within the last three months
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steno Diabetes Center Copenhagenlead
- Hillerod Hospital, Denmarkcollaborator
- Hvidovre University Hospitalcollaborator
- Bispebjerg Hospitalcollaborator
- Rigshospitalet, Denmarkcollaborator
- Frederiksberg University Hospitalcollaborator
- Amager Hospitalcollaborator
Study Sites (1)
Steno Diabetes Center Copenhagen
Copenhagen, Denmark
Related Publications (2)
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.
PMID: 34495375DERIVEDSecher 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.
PMID: 32345699DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 24, 2018
Study Start
October 1, 2018
Primary Completion
October 26, 2020
Study Completion
October 26, 2020
Last Updated
October 28, 2020
Record last verified: 2020-10