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Diabetes MellitusSECONDNCT03545178

Systematic Evaluation of Continuous Glucose Monitoring Data

An observational study of Diabetes Mellitus, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
hypoglycemia prediction (Substudy B)
How many people
384 participants
Where
1 siteSwitzerland
Study dates
1 Apr 2018to 19 Jul 2019
Phase
Observational
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients suffering from diabetes mellitus controlled at our tertiary referral centre using a CGM/FMG device for at least 50% of the time

Who may be able to join

  • Diabetes mellitus
  • CGM and/or FGM available for at least 50% of the time in last 4 weeks before consultation
  • Written informed general consent for the retrospective analysis of data

Who cannot join

  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Inselspital, Bern University Hospital, University of Bern

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

Official title: Systematic Evaluation of Continuous Glucose Monitoring Data to for the Development of Clinical Solutions

This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). Second, the investigators use the collected CGM and FGM data to develop a hypoglycemia prediction model.

Read the detailed description

Substudy A.) Presence of white coat adherence in diabetic patients:

The investigators aim at evaluating the existence of a so called "white coat adherence" with regard to diabetes control, which means that blood-glucose is better controlled in the days immediately prior to a consultation at the diabetes clinic compared to the time-period further back. To analyse this phenomenon, the investigators use continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) of diabetic patients and compare CGM-/FGM data of the last three days prior to the consultation with the CGM-/FGM data of the days 4-28 prior to the consultation, as well as the last seven days prior to the consultation with days 8-28 prior to the consultation.

Substudy B.) Retrospective data collection for the development and evaluation of a hypoglycemia prediction model:

Scope of the study is to use retrospective data for training and evaluation of a deep recurrent neural network based system for predicting the onset of hypoglycemic event at least 20 min ahead in time. The study aims to: I, assess the ability of deep learning algorithm to predict hypoglycemic events using the data collected during substudy 1. II, assess the ability of global model to be personalized using the data collected during sub-study 1. III, investigate the amount of "history" to be involved to achieve maximum performance in terms of prediction ability. IV, develop a global model, which can be easily further personalized to achieve optimum prediction performance per patient.

Being tested
glucose control (Substudy A), hypoglycemia prediction (Substudy B)
Keywords
white coat adherence, continuous glucose monitoring, flash glucose monitoring, hypoglycemia prediction, deep learning algorithm
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • glucose control (Substudy A)Behavioural

    Comparison of glucose values during days 0 - 3 with days 4 - 28 and 0 - 7 with days 8 - 28 before a medical consultation at the diabetes clinic in patients suffering from diabetes and wearing a continuous glucose monitoring and/or flash glucose monitoring device

  • hypoglycemia prediction (Substudy B)Diagnostic test

    Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model

Study groups in NCT03545178
Study groupRoleWhat they receive
Diabetic patients using CGM/FGMEvaluation of glucose control and application of hypoglycemia prediction models in diabetic patients wearing CGM and/or FGM devices for at least 50% of the time during the last 4 weeks prior to the medical consultation.
Receives: Behavioral: glucose control (Substudy A); Diagnostic Test: hypoglycemia prediction (Substudy B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of time in target glucose range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    The time spent in the target glucose range from 3.9 to 10.0 mmol/l assessed by CGM/FGM.

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  2. Hypoglycemia prediction (for Substudy B)

    Proportion of times a deep learning based algorithm can predict a hypoglycemic event (BG <4.0 mmol/l) at least 20 min ahead in time?

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

Secondary outcomes (7)

  1. Change of time above and below glucose target range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    The time spent above and below the target glucose (3.9 to 10.0 mmol/l) assessed by CGM/FGM.

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  2. Change of average and standard deviation glucose day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Average and standard deviation glucose levels based on CGM/FGM data

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  3. Sensor wearing time day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Time CGM-/FGM sensor has been worn (%)

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  4. Change of coefficient of variation (CV) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    Coefficient of variation (CV) based on CGM/FGM data

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  5. Change of time in hypoglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    The time with glucose levels < 3.0 based on CGM/FGM data

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  6. Change of time in hyperglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    The time with glucose levels in the significant hyperglycaemia, as based on CGM/FGM (glucose levels > 13.9 mmol/l)

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

  7. Change of mean amplitude of glucose excursion (MAGE) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A)

    The mean amplitude of glucose excursion assessed by CGM/FGM

    Measured: 01.01.2013 - 31.07.2018; outcome assessed at study end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2018
  2. Study start1 Apr 2018
  3. Primary completion19 Jul 2019
  4. Study completion19 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03545178
Sponsor's protocol ID
2018-00207
Other IDs
2018
Acronym
SECOND
Status last verified
Aug 2019
First submitted
18 Apr 2018
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 3 inclusion and 1 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 13 Aug 2019. 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 Switzerland. 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?

Change of time in target glucose range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) (time frame: 01.01.2013 - 31.07.2018; outcome assessed at study end). The study lists 2 primary outcomes in all. 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 NCT03545178.

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 13 Aug 2019.

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