Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3

NCT05216926 | Completed

• 1 other identifier: PBH Forecast (WP 3)
• Study Type: interventional
• Target: 60
• 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)

• Hypoglycaemia

  Proportion of participants with hypoglycaemia (nadir plasma glucose \<3.0 mmol/L)

  In the 180 minutes following the beginning of meal intake

Secondary Outcomes (5)

• Plasma glucose <3.0 mmol/L

  During 180 minutes following the beginning of meal intake

• Plasma glucose <3.9 mmol/L

  During 180 minutes following the beginning of meal intake

• Plasma glucose ≥10.0 mmol/L

  During 180 minutes following the beginning of meal intake

• Mean plasma glucose

  During 180 min following onset of meal intake

• Peak plasma glucose

  In the 180 min following onset of meal intake

Study Arms (2)

Hypoglycemia predicition and preventive treatment

EXPERIMENTAL

Other: Timing of preventive action based on prediction model

Corrective hypoglycemia treament (at hypogylcemia)

OTHER

Other: Hypoglycaemia treatment at hypoglycaemia (usual care)

Interventions

Timing of preventive action based on prediction model OTHER

Timing of preventive action based on prediction model

Hypoglycemia predicition and preventive treatment

Hypoglycaemia treatment at hypoglycaemia (usual care) OTHER

Hypoglycaemia treatment at hypoglycaemia (usual care)

Corrective hypoglycemia treament (at hypogylcemia)

Eligibility Criteria

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

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

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to to group allocation, sensor and plasma glucose.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• 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: February 1, 2022
• Study Start: January 18, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 31, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

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)