Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3 (PBH Forecast)

Forecasting and Preventing Post-Bariatric Hypoglycaemia (Work Package 3)

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.

Study Overview

• Status: Completed
• Conditions: Post-bariatric Hypoglycaemia; Roux-en-Y Gastric Bypass
• Intervention / Treatment: Other: Timing of preventive action based on prediction model; Other: Hypoglycaemia treatment at hypoglycaemia (usual care)

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 3 is to test the efficacy of an intervention for hypoglycaemia prevention that combines a hypoglycaemia prediction model with a preventive nutritional action.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, 3010
      • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypoglycemia predicition and preventive treatment	Other: Timing of preventive action based on prediction model; Timing of preventive action based on prediction model
Other: Corrective hypoglycemia treament (at hypogylcemia)	Other: Hypoglycaemia treatment at hypoglycaemia (usual care); Hypoglycaemia treatment at hypoglycaemia (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycaemia	Proportion of participants with hypoglycaemia (nadir plasma glucose <3.0 mmol/L)	In the 180 minutes following the beginning of meal intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose <3.0 mmol/L	Percentage of post-prandial time with plasma glucose <3.0 mmol/L	During 180 minutes following the beginning of meal intake
Plasma glucose <3.9 mmol/L	Percentage of post-prandial time with plasma glucose <3.9 mmol/L	During 180 minutes following the beginning of meal intake
Plasma glucose ≥10.0 mmol/L	Percentage of post-prandial time with plasma glucose ≥10.0 mmol/L	During 180 minutes following the beginning of meal intake
Mean plasma glucose	Mean plasma glucose concentration	During 180 min following onset of meal intake
Peak plasma glucose	Peak plasma glucose	In the 180 min following onset of meal intake

Collaborators and Investigators

• Sponsor: Lia Bally
• Collaborators: University of Padova
• Investigators: Principal Investigator: Lia Bally, Prof. Dr. med. et phil., Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, lnselspital, Bern University Hospital, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: PBH Forecast (WP 3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available to other researchers.
• IPD Sharing Time Frame: After study completion, 10 years
• IPD Sharing Access Criteria: After written inquiry and approval by the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No