Diabetes Mellitus, Type 1NCT03682237
Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study
A study testing Carbohydrate counting, automated bolus calculation and Flash glucose monitoring (FGM) in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Carbohydrate counting, automated bolus calculation and Flash glucose monitoring (FGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 26 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this 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?
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Carbohydrate counting, automated bolus calculation, Flash glucose monitoring (FGM)
- Keywords
- Hyperglycemia, Hypoglycemia, Carbohydrate counting, Automated bolus calculation, Flash glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate counting, automated bolus calculationDevice
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.
Flash glucose monitoring (FGM)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| A) Standard diabetes training (control) | No intervention | 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 | Not described Receives: Device: Carbohydrate counting, automated bolus calculation |
| C) Flash glucose monitoring (FGM) | Active comparator | Group training with same content as for group A. Receives: Device: Flash glucose monitoring (FGM) |
| D) Carbohydrate counting, automated bolus calculation, FGM | Active comparator | 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). Receives: Device: Carbohydrate counting, automated bolus calculation; Device: Flash glucose monitoring (FGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 26 weeks
Secondary outcomes (16)
HbA1c
Difference among groups in change in HbA1c (mmol/mol).
Measured: 26 weeks
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).
Measured: 26 weeks
Hypoglycemia
Difference among groups in occurrence of symptomatic and confirmed hypoglycemia (< 3 mmol/l) (number of episodes per week).
Measured: 26 weeks
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).
Measured: 26 weeks
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).
Measured: 26 weeks
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)).
Measured: 26 weeks
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).
Measured: 26 weeks
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.
Measured: 26 weeks
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.
Measured: 26 weeks
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.
Measured: 26 weeks
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).
Measured: 26 weeks
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.
Measured: 26 weeks
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.
Measured: 26 weeks
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.
Measured: 26 weeks
Body weight
Difference among groups in body weight (kg).
Measured: 26 weeks
Urinary albumin/excretion rate
Difference among groups in urinary albumin/excretion rate (mg/24 hours).
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hillerod Hospital, Denmark, Hvidovre University Hospital, Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet, Frederiksberg University Hospital, Amager Hospital
- Responsible party
- Principal investigator, Kirsten Nørgaard, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682237
- Sponsor's protocol ID
- H-17040573
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34495375Secher 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.
PubMed 32345699
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03682237
- Acronym / sponsor ID
- H-17040573
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Hyperglycemia, Hypoglycemia, Carbohydrate counting, Automated bolus calculation, Flash glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Hillerod Hospital, Denmark, Hvidovre University Hospital, Bispebjerg Hospital, Copenhagen University Hospital, Rigshospitalet, Frederiksberg University Hospital, Amager Hospital
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A) Standard diabetes training (control) | No intervention | –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 | Device: Carbohydrate counting, automated bolus calculation |
| C) Flash glucose monitoring (FGM) | Active comparator | Device: Flash glucose monitoring (FGM)Group training with same content as for group A. |
| D) Carbohydrate counting, automated bolus calculation, FGM | Active comparator | Device: Carbohydrate counting, automated bolus calculation, Device: Flash glucose monitoring (FGM)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate counting, automated bolus calculationGroup 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. | Device | B) Carbohydrate counting, automated bolus calculation, D) Carbohydrate counting, automated bolus calculation, FGM |
| Flash glucose monitoring (FGM)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. | Device | C) Flash glucose monitoring (FGM), D) Carbohydrate counting, automated bolus calculation, FGM |
Primary outcome
Time in normoglycemia
Time frame: 26 weeks
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).
16 secondary outcomes
HbA1c
Time frame: 26 weeks
Severe hypoglycemia
Time frame: 26 weeks
Hypoglycemia
Time frame: 26 weeks
Diabetes distress
Time frame: 26 weeks
Diabetes treatment satisfaction
Time frame: 26 weeks
Diabetes empowerment
Time frame: 26 weeks
Diabetes quality of life
Time frame: 26 weeks
Blinded FGM hypoglycemia
Time frame: 26 weeks
Blinded FGM hyperglycemia
Time frame: 26 weeks
Blinded FGM glycemic variability
Time frame: 26 weeks
Personality traits
Time frame: 26 weeks
Total insulin dose
Time frame: 26 weeks
Total basal insulin dose
Time frame: 26 weeks
Insulin boluses
Time frame: 26 weeks
Body weight
Time frame: 26 weeks
Urinary albumin/excretion rate
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Derived from this study: PubMed 34495375Secher 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.
- Derived from this study: PubMed 32345699Secher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate counting, automated bolus calculation and Flash glucose monitoring (FGM) in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in normoglycemia (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682237, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020; AzTrials last refreshed its copy on 30 Oct 2026.