search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Carbohydrate counting, automated bolus calculation
Flash glucose monitoring (FGM)
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Hyperglycemia, Hypoglycemia, Carbohydrate counting, Automated bolus calculation, Flash glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Steno Diabetes Center Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

A) Standard diabetes training (control)

B) Carbohydrate counting, automated bolus calculation

C) Flash glucose monitoring (FGM)

D) Carbohydrate counting, automated bolus calculation, FGM

Arm 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.

Group training with same content as for group A.

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

HbA1c
Difference among groups in change in HbA1c (mmol/mol).
Severe hypoglycemia
Difference among groups in occurrence of severe hypoglycemia (defined as an event requiring assistance of another person. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal) (number of events during study period).
Hypoglycemia
Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (< 3 mmol/l) (number of episodes per week).
Diabetes distress
Difference in changes in diabetes distress by the use of Problem Areas in Diabetes Questionnaire (PAID, score 0-100; higher scores reflecting diabetes distress).
Diabetes treatment satisfaction
Difference in changes in treatment satisfaction by the use of Diabetes Treatment Satisfaction Questionnaire (DTSQ, score 0-36; higher scores reflecting higher satisfaction).
Diabetes empowerment
Difference in changes in empowerment by the use of Diabetes empowerment test (DES-short form, containing 8 items, higher scores reflecting diabetes-related psychosocial self-efficacy. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point, and an overall score is calculated by adding all of the scores (8-40) and dividing by the number of completed items (highest number is 8)).
Diabetes quality of life
Difference in changes in life quality by the use of Diabetes quality of life (ADDQoL-19, scores -9-3, lower scores reflecting maximum negative impact).
Blinded FGM hypoglycemia
Difference in change in time spent in hypoglycemia (<3mmol/l, <4 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Blinded FGM hyperglycemia
Difference in change in time spent in hyperglycemia (>10 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Blinded FGM glycemic variability
Difference in change in glycemic variability (standard deviation) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Personality traits
Association between personality traits evaluated by the use of Neuroticism Extraversion Openness Agreeableness Conscientiousness Five-Factor Inventory-3 (NEO-Five Factors Inventory-3) questionnaire and any other outcome measures in the different groups. The NEO-Five Factors Inventory-3 covers five factors/domains that describe the commonly accepted personality traits. The inventory contains 60 statements that should be evaluated by self-ratings on a 5-point scale where 1 reflects "strongly disagree" and 5 reflects "strongly agree". The answers are related to the norm and based on these scores, personality traits are reported by the internet based Hogrefe Testsystem 5 (Hogrefe Publishing Group).
Total insulin dose
Difference in change between the groups in total insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Total basal insulin dose
Difference in change between the groups in total basal insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Insulin boluses
Difference in change between the groups in number of insulin boluses per day (number/day) recorded as a mean of 2 weeks during FGM blinded measurements.
Body weight
Difference among groups in body weight (kg).
Urinary albumin/excretion rate
Difference among groups in urinary albumin/excretion rate (mg/24 hours).

Full Information

First Posted
September 13, 2018
Last Updated
October 27, 2020
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Hillerod Hospital, Denmark, Hvidovre University Hospital, Bispebjerg Hospital, Rigshospitalet, Denmark, Frederiksberg University Hospital, Amager Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03682237
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Hillerod Hospital, Denmark, Hvidovre University Hospital, Bispebjerg Hospital, Rigshospitalet, Denmark, Frederiksberg University Hospital, Amager Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Hyperglycemia, Hypoglycemia, Carbohydrate counting, Automated bolus calculation, Flash glucose monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A) Standard diabetes training (control)
Arm Type
No Intervention
Arm 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.
Arm Title
B) Carbohydrate counting, automated bolus calculation
Arm Type
Active Comparator
Arm Title
C) Flash glucose monitoring (FGM)
Arm Type
Active Comparator
Arm Description
Group training with same content as for group A.
Arm Title
D) Carbohydrate counting, automated bolus calculation, FGM
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Carbohydrate counting, automated bolus calculation
Intervention 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(s)
Flash glucose monitoring (FGM)
Intervention 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.
Primary Outcome Measure Information:
Title
Time in normoglycemia
Description
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).
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
Difference among groups in change in HbA1c (mmol/mol).
Time Frame
26 weeks
Title
Severe hypoglycemia
Description
Difference among groups in occurrence of severe hypoglycemia (defined as an event requiring assistance of another person. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal) (number of events during study period).
Time Frame
26 weeks
Title
Hypoglycemia
Description
Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (< 3 mmol/l) (number of episodes per week).
Time Frame
26 weeks
Title
Diabetes distress
Description
Difference in changes in diabetes distress by the use of Problem Areas in Diabetes Questionnaire (PAID, score 0-100; higher scores reflecting diabetes distress).
Time Frame
26 weeks
Title
Diabetes treatment satisfaction
Description
Difference in changes in treatment satisfaction by the use of Diabetes Treatment Satisfaction Questionnaire (DTSQ, score 0-36; higher scores reflecting higher satisfaction).
Time Frame
26 weeks
Title
Diabetes empowerment
Description
Difference in changes in empowerment by the use of Diabetes empowerment test (DES-short form, containing 8 items, higher scores reflecting diabetes-related psychosocial self-efficacy. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point, and an overall score is calculated by adding all of the scores (8-40) and dividing by the number of completed items (highest number is 8)).
Time Frame
26 weeks
Title
Diabetes quality of life
Description
Difference in changes in life quality by the use of Diabetes quality of life (ADDQoL-19, scores -9-3, lower scores reflecting maximum negative impact).
Time Frame
26 weeks
Title
Blinded FGM hypoglycemia
Description
Difference in change in time spent in hypoglycemia (<3mmol/l, <4 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Time Frame
26 weeks
Title
Blinded FGM hyperglycemia
Description
Difference in change in time spent in hyperglycemia (>10 mmol/l) (min/day) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Time Frame
26 weeks
Title
Blinded FGM glycemic variability
Description
Difference in change in glycemic variability (standard deviation) from baseline (2 weeks) to end of study (2 weeks) in the different study groups.
Time Frame
26 weeks
Title
Personality traits
Description
Association between personality traits evaluated by the use of Neuroticism Extraversion Openness Agreeableness Conscientiousness Five-Factor Inventory-3 (NEO-Five Factors Inventory-3) questionnaire and any other outcome measures in the different groups. The NEO-Five Factors Inventory-3 covers five factors/domains that describe the commonly accepted personality traits. The inventory contains 60 statements that should be evaluated by self-ratings on a 5-point scale where 1 reflects "strongly disagree" and 5 reflects "strongly agree". The answers are related to the norm and based on these scores, personality traits are reported by the internet based Hogrefe Testsystem 5 (Hogrefe Publishing Group).
Time Frame
26 weeks
Title
Total insulin dose
Description
Difference in change between the groups in total insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Time Frame
26 weeks
Title
Total basal insulin dose
Description
Difference in change between the groups in total basal insulin dose (units/day/kg) recorded as a mean of 2 weeks during FGM blinded measurements.
Time Frame
26 weeks
Title
Insulin boluses
Description
Difference in change between the groups in number of insulin boluses per day (number/day) recorded as a mean of 2 weeks during FGM blinded measurements.
Time Frame
26 weeks
Title
Body weight
Description
Difference among groups in body weight (kg).
Time Frame
26 weeks
Title
Urinary albumin/excretion rate
Description
Difference among groups in urinary albumin/excretion rate (mg/24 hours).
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34495375
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. Erratum In: Diabetologia. 2022 Jan;65(1):256.
Results Reference
derived
PubMed Identifier
32345699
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs