Clinical trial NCT03682237: Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study
Official title: Optimizing Metabolic Control in Type 1 Diabetes With Multiple Daily Insulin Injections - Flash Glucose Monitoring, Carbohydrate Counting With Automated Bolus Calculation, or Both?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Hyperglycemia
Hypoglycemia
Carbohydrate counting
Automated bolus calculation
Flash glucose monitoring
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Hillerod Hospital, Denmark
name: Hvidovre University Hospital
name: Bispebjerg Hospital
name: Rigshospitalet, Denmark
name: Frederiksberg University Hospital
name: Amager Hospital
First posted: 2018-09-24
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time in normoglycemia
timeFrame: 26 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 26 weeks
measure: Severe hypoglycemia
timeFrame: 26 weeks
measure: Hypoglycemia
timeFrame: 26 weeks
measure: Diabetes distress
timeFrame: 26 weeks
measure: Diabetes treatment satisfaction
timeFrame: 26 weeks
measure: Diabetes empowerment
timeFrame: 26 weeks
measure: Diabetes quality of life
timeFrame: 26 weeks
measure: Blinded FGM hypoglycemia
timeFrame: 26 weeks
measure: Blinded FGM hyperglycemia
timeFrame: 26 weeks
measure: Blinded FGM glycemic variability
timeFrame: 26 weeks
measure: Personality traits
timeFrame: 26 weeks
measure: Total insulin dose
timeFrame: 26 weeks
measure: Total basal insulin dose
timeFrame: 26 weeks
measure: Insulin boluses
timeFrame: 26 weeks
measure: Body weight
timeFrame: 26 weeks
measure: Urinary albumin/excretion rate
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
References:
citation: 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.
citation: 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.