Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05216926
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2022-01-14
Brief Title:
Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3
Sponsor:
Lia Bally
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Forecasting and Preventing Post-Bariatric Hypoglycaemia Work Package 3
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBH Forecast
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
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 34 mmolL 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
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 34 mmolL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None