Glycemic Profile by CGMS in Diabetic Patients After Bariatric Surgery (CGM-BARIA)

Evaluation by CGMS (Continuous Glucose Monitoring System) of the Evolution of the Glycemic Profile in Diabetic Patients in Immediate Post-operative Bariatric Surgery: An Observational Study in Routine Care

The aim of this observational prospective monocentric study is to examine glycemic patterns in adult T2D patients candidates to bariatric surgery, by using a continuous glucose monitoring (CGM) sensor over 14 days post-surgery, in order to search for indicators predicting T2D remission 1 year after surgery.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus in Obese; Bariatric Surgery Candidate
• Intervention / Treatment: Other: routine care. No intervention

Detailed Description

In this exploratory monocentric study performed at the Caen University Hospital in France, adult T2D patients consecutively enrolled for metabolic surgery will be prospectively included for continuous glucose monitoring (CGM) recordings during the month preceding bariatric surgery and during the 2 weeks following surgery. Changes in body weight will be evaluated using weight measurement, BMI measurement and the percentage of excess weight loss (% EWL), calculated using the formula: initial weight-actual weight/initial weight - (25 x height2). Changes in diabetic status will be evaluated by HbA1c assay and collection of data on anti-diabetic treatment maintained during the follow-up. The Ad-Diarem score for predicting diabetes remission will be calculated in each patient from several variables including age, diabetes duration, insulin use, other glucose-lowering agents used, number of glucose-lowering agents used and HbA1c level. The variables recorded by CGM will include : mean daily interstitial glucose concentration (mg/dL), standard deviation (SD) of glucose concentration (mg/dL), coefficient of variation (CV) of glucose concentration corresponding to the SD-to-mean daily interstitial glucose ratio, time in normoglycemia (ie in the stringent 70-140mg/dL target which better reflects normoglycemia than the 70-180 mg/dl target) or time in range (TIR) as a percentage over 24h, time spent in hyperglycemia (ie >140mg/dL) or time above range (TAR) as a percentage over 24h, and time spent in hypoglycemia (<70mg/dL) or time below range (TBR) as a percentage over 24h.

Judgement criteria are defined as follows: the success of bariatric surgery will be defined as a % EWL >50%; normalization of glycemia will be defined as a mean 24-hr interstitial glucose level <100mg/d during the CGM recording period; diabetes remission after metabolic surgery will be defined as an HbA1c level at 1 year after surgery of < 6.0% without the use of any glucose-lowering agent. Such thresholds were chosen to meet the definition of complete remission by the American Society for Metabolic and Bariatric Surgery and the American Diabetes Association.

Quantitative variables will be expressed as mean + standard deviation. Qualitative variables will be expressed as percentages. Differences in quantitative variables, when compared to the pre-operative period, will be examined using Students t-test for paired data or with ANOVA. Analysis of subgroups will be carried out using Chi-2 test. Identification of predictive factors for diabetes remission will be based on analysis of ROC curves and the calculation of area under the curve data, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive and negative likelihood ratio (LR+ and LR-) at different thresholds for each study variable including the pre-operative and post-operative CGM variables and the Add-Diarem score.

• Study Type: Observational
• Enrollment (Actual): 31

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

T2D, obesity (BMI>35), candidates for metabolic surgery oral or injectable anti diabetic treatments including insulin injections or pump therapy

Description

Inclusion Criteria:

• type 2 diabetes and obesity (BMI> 35)
• treated with oral anti-diabetic medication and/or insulin therapy
• candidate for bariatric surgery

Exclusion Criteria:

• refusal of CGM recordings
• refusal of bariatric surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T2D diabetes obese subjects; Patients have T2D diabetes and are candidates for bariatric surgery. They will receive routine cares and follow-up and will have CGM measurement before and 2 weeks following the surgery	Other: routine care. No intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycemic profile after bariatric surgery	CGM recordings 4-14 days of the immediate postoperative period	4-14 days recordings

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glycemic profile before bariatric surgery	CGM recordings before bariatric surgery	5 days recordings
identification of predictive factors for diabetes remission 1 year after surgery	CGM variables and Add-Diarem score	5 days recordings for CGM

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2016
• Primary Completion (ACTUAL): March 30, 2018
• Study Completion (ACTUAL): May 30, 2018

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: continuous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CHU 20-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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