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

Optimizing Metabolic Control in Type 1 Diabetes With Multiple Daily Insulin Injections - Flash Glucose Monitoring, Carbohydrate Counting With Automated Bolus Calculation, or Both?

Sponsors

Lead Sponsor: Steno Diabetes Center Copenhagen

Collaborator: Hillerod Hospital, Denmark
Hvidovre University Hospital
Bispebjerg Hospital
Rigshospitalet, Denmark
Frederiksberg University Hospital
Amager Hospital

Source Steno Diabetes Center Copenhagen
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.

Overall Status Active, not recruiting
Start Date October 1, 2018
Completion Date December 31, 2020
Primary Completion Date November 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Time in normoglycemia 26 weeks
Secondary Outcome
Measure Time Frame
HbA1c 26 weeks
Severe hypoglycemia 26 weeks
Hypoglycemia 26 weeks
Diabetes distress 26 weeks
Diabetes treatment satisfaction 26 weeks
Diabetes empowerment 26 weeks
Diabetes quality of life 26 weeks
Blinded FGM hypoglycemia 26 weeks
Blinded FGM hyperglycemia 26 weeks
Blinded FGM glycemic variability 26 weeks
Personality traits 26 weeks
Total insulin dose 26 weeks
Total basal insulin dose 26 weeks
Insulin boluses 26 weeks
Body weight 26 weeks
Urinary albumin/excretion rate 26 weeks
Enrollment 184
Condition
Intervention

Intervention Type: Device

Intervention Name: Carbohydrate counting, automated bolus calculation

Description: 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.

Intervention Type: Device

Intervention Name: Flash glucose monitoring (FGM)

Description: 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:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Steno Diabetes Center Copenhagen
Location Countries

Denmark

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Steno Diabetes Center Copenhagen

Investigator Full Name: Kirsten Nørgaard

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: A) Standard diabetes training (control)

Type: No Intervention

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.

Label: B) Carbohydrate counting, automated bolus calculation

Type: Active Comparator

Label: C) Flash glucose monitoring (FGM)

Type: Active Comparator

Description: Group training with same content as for group A.

Label: D) Carbohydrate counting, automated bolus calculation, FGM

Type: Active Comparator

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).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov