Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study

Steno Diabetes Centers

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Carbohydrate counting, automated bolus calculation; Device: Flash glucose monitoring (FGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03682237

H-17040573

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 4 patient groups

A) Standard diabetes training (control)

No Intervention group

Description:

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 group

Treatment:

Device: Carbohydrate counting, automated bolus calculation

C) Flash glucose monitoring (FGM)

Active Comparator group

Description:

Group training with same content as for group A.

Treatment:

Device: Flash glucose monitoring (FGM)

D) Carbohydrate counting, automated bolus calculation, FGM

Active Comparator group

Description:

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).

Treatment:

Device: Flash glucose monitoring (FGM)

Device: Carbohydrate counting, automated bolus calculation