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Post-bariatric HypoglycaemiaPBH ForecastNCT05212207

Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 1

An observational study of Post-bariatric Hypoglycaemia and Roux-en-Y Gastric Bypass, run by Lia Bally 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

The overall aim of this study is to prevent hypoglycemic events in patients with hypoglycemia after a meal and to develop a sustainable hypoglycemia correction strategy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CGM, smartwatch, and electronic diary
How many people
50 participants
Where
1 siteSwitzerland
Study dates
18 Jan 2022to 26 Jul 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of post-bariatric patients with PBH.

Who may be able to join

  • Post-bariatric surgery patients (Roux-en-Y gastric bypass) with PBH, defined as postprandial plasma or sensor glucose <3.0 mmol/L according to the International Hypoglycaemia Study Group and exclusion of other causes of hypoglycaemia
  • Age ≥18 years

Who cannot join

  • Inability to give informed consent as documented by signature
  • Pregnant or lactating women
  • Inability or contraindications to undergo the investigated intervention
  • Drugs interfering with blood glucose (e.g. SGLT-2 inhibitors, acarbose) during the time of investigation
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

Official title: Forecasting and Preventing Post-Bariatric Hypoglycaemia (Work Package 1)

The overall aim of this study is to prevent hypoglycemic events in patients with hypoglycemia after a meal and to develop a sustainable hypoglycemia correction strategy.

Read the detailed description

Obesity is a major global public health concern, for which the most effective therapy is bariatric surgery. Beyond weight loss, bariatric surgery exerts powerful effects on glucose metabolism, achieving complete type 2 diabetes remission in up to 70% of cases. An exaggeration of these effects, however, can result in an increasingly recognized metabolic complication known as postprandial hyperinsulinaemic hypoglycaemia or post-bariatric hypoglycaemia (PBH). The condition manifests 1-3 years after surgery with meal-induced hypoglycaemic episodes. Emerging data suggests that PBH is more frequent than previously thought and affects approximately 30% of postoperative patients, more commonly after gastric bypass than sleeve gastrectomy. Of note, asymptomatic PBH is common, as shown in studies using continuous glucose monitoring (CGM). It is known from extensive research in people with diabetes that recurrent episodes of hypoglycaemia impair counter regulatory defences against subsequent events, predisposing patients to severe hypoglycaemia.

Despite the increasing prevalence of PBH, clinical implications in this population are still unclear. Anecdotal evidence from patients with PBH suggests a high burden for these patients due to the recurrent hypoglycaemias with possibly debilitating consequences. It is well established that even mild hypoglycaemia (plasma glucose of 3.4 mmol/L) in diabetic and non-diabetic patients impairs various cognitive domains. Of note, some of the cognitive functions remain impaired for up to 75 min, even when the hypoglycaemia is corrected. Further concerns exist from observational studies showing associations between PBH during pregnancy and poor foetal growth.

Thus, it is important to timely detect and treat hypoglycaemia with an intervention that allows quick recovery of glycaemia to a safe level, thereby alleviating symptoms and eliminating the risk of potentially hazardous sequelae. Recently, CGM devices have become standard tools for glucose monitoring in patients with diabetes. CGM allows measuring glucose levels every 5 min and the continuous access to real-time data offering several approaches for the prediction of glucose levels or associated events. Such solutions empower patients to take proactive decisions before reaching critical glucose levels. Apart from glucose levels, meal information, physical activity or other physiological parameters may augment prediction performance of hypoglycaemic events. While most engineering work focuses on the prediction of hypoglycaemia in the diabetic population, only preliminary work has been done in the PBH population.

Given the potentially hazardous consequences of hypoglycaemia, development of hypoglycaemia management strategies to adequately predict and treat critical blood glucose levels in the PBH population are urgently needed. Such strategies have to significantly lower the burden of PBH and increase patient safety.

The overall aim or this study is to prevent hypoglycaemic events in patients with PBH and to develop a sustainable hypoglycaemia correction strategy.

The primary objective of WP 1 is to develop a hypoglycaemia prediction model based on sensor glucose data. Furthermore, the investigators will try to improve the prediction by including further data streams such as information about meal intake, heart rate and activity data.

Being tested
CGM, smartwatch, and electronic diary
Keywords
Continuous Glucose Monitoring

What participants receive

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

  • CGM, smartwatch, and electronic diaryOther

    Participants wear a CGM and a smartwatch while keeping an electronic diary with information such as meals, sleep, and activity.

Study groups in NCT05212207
Study groupRoleWhat they receive
PBHNot described
Receives: Other: CGM, smartwatch, and electronic diary

What is being measured

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

  1. Precision (fraction of correct alarms over the total number of raised alarms) and recall (fraction of correctly predicted hypoglycaemic events over the total number of episodes)

    Selecting the best performing hypoglycaemia prediction

    Measured: 10 days

Secondary outcomes (2)
  1. False alarms

    Daily number of false alarms triggered by the algorithms (FP-per-day)

    Measured: 10 days

  2. Time anticipation

    Time anticipation between the hypoglycaemic alarms raised by the model and the hypoglycaemic episode

    Measured: 10 days

Timeline

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

  1. First posted28 Jan 2022
  2. Study start18 Jan 2022
  3. Primary completion26 Jul 2023
  4. Study completion26 Jul 2023

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
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212207
Sponsor's protocol ID
PBH Forecast (WP 1)
Acronym
PBH Forecast
Status last verified
Aug 2023
First submitted
14 Jan 2022
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication will be available to other researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Post-bariatric Hypoglycaemia and Roux-en-Y Gastric Bypass, run by Lia Bally 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 2 inclusion and 5 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 23 Aug 2023. 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?

Precision (fraction of correct alarms over the total number of raised alarms) and recall (fraction of correctly predicted hypoglycaemic events over the total number of episodes) (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Aug 2023.

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