Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 1

NCT05212207 | Completed

• 1 other identifier: PBH Forecast (WP 1)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-bariatric Hypoglycaemia; Roux-en-Y Gastric Bypass

Keywords

Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (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

  10 days

Secondary Outcomes (2)

• False alarms

  10 days

• Time anticipation

  10 days

Study Arms (1)

PBH

Other: CGM, smartwatch, and electronic diary

Interventions

CGM, smartwatch, and electronic diary OTHER

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

PBH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lia Bally: lead
• University of Padova: collaborator

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Lia Bally, Prof. Dr. med. et phil.

  Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, lnselspital, Bern University Hospital, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nutrition, Metabolism and Obesity and Head of Research

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 28, 2022
• Study Start: January 18, 2022
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After study completion, 10 years
• Access Criteria: After written inquiry and approval by the principal investigator.

Locations

CH (1)