Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533618
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Characterization of the Transfusion-dependent Prediabetes Using Continuous Glucose Monitoring
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization of the Transfusion-dependent Prediabetes Using Continuous Glucose Monitoring the Hemoglycare Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dysglycemia is a frequent finding in transfusion-dependent thalassemia TDT The oral glucose tolerance test OGTT remains the only validated screening test but the procedure is complex and time-consuming Continuous glucose monitoring CGM systems are simple to use and could have a role in the diabetes mellitus diagnosis This study involved 39 participants 19 cases and 20 healthy controls using CGM for the analysis of the glucose metrics Participants resulted negative for diabetes mellitus screening tests Patients clinical data were compared with glucose metrics
Detailed Description:
The selection of patients took place randomly among adult patients suffering from transfusion-dependent thalassemia TDT belonging to the Pediatric Hematology and Oncology Unit of the AOU University of Campania L Vanvitelli Patients had a history of at least 10 years of therapy with red blood cell transfusions transfusion frequency less than one months and iron chelation therapy Cases tested negative for diabetes mellitus screening tests fasting glycemia OGTT
Some healthy volunteers were also recruited among medical resident and doctors Major eligibility criteria for the volunteers were caucasian age 18 years body mass index 250 kgm2 no chronic illness or medications that might affect glucose metabolism fasting glycemia100 mgdl HbA1c 57 39 mmolmol no positive islet autoantibodies HOMA-IR 25 Female participants pregnant at the time of study enrollment were not eligible
All procedures performed in this study were approved by the Institutional Research Committee of the University of Campania Luigi Vanvitelli All participants have provided written consent
Demographic and Clinical characteristics A brief schedule was specifically designed and completed by clinicians diabetologists or hematologists to record demographic and clinical data including age gender height weight duration of illness and other medical conditions family history of diabetes endocrine disorders cigarette smoking habit Finally the HOMA-IR was calculated as a parameter for evaluating insulin resistance Possible missing data was obtained by reviewing medical charts
Study design
All participants subjects and controls applied a Medtronic Guardian4 sensor for seven days At the end of the monitoring the glucose sensor data was analyzed using the Carelink System software
Glucose metrics considered for the analysis were glucose management indicator GMI mean glucose mgdl glycemic variability as standard deviation SD and coefficient of variation CV time spent with glycemia greater than or equal to 200 mg dl TAR200median time spent with blood glucose greater than or equal to 140 mgdl TAR140 median time spent with blood glucose less than 70 mgdl TBR70 median
As it is described in the American Diabetes Association ADA guidelines 2h-glucose value 140 mgdl 78 mmolL and 199 mgdl 11 mmoll during OGTT is diagnostic for prediabetes Moreover 2h glucose value 200 mgdl111 mmolL during OGTT or a random glucose value in any time of the day without regard to time since previous meal 200 mgdl111 mmolL are both diagnostic for diabetes mellitus
During a continuous glucose monitoring CGM it is not easy to understand correlation between glucose values and meals Furthermore in this study the evaluation of glucose values during CGM two hours after a controlled meal 75-g of oral glucose in OGTT was not performed Instead the participants glucose values were observed in real life Therefore although the number of participants who exceeded or equaled the value 140 mgdl or the value 200mgdl was recorded in addition how long these patients remained with glucose values above these cut-offs TAR140 TAR200was registered to make the observation of abnormal glycemic profiles more precise
Finally the value 6 of TAR 140was used as an index of normality as indicated in other studies on healthy volunteers
Some healthy volunteers were also recruited among medical resident and doctors Major eligibility criteria for the volunteers were caucasian age 18 years body mass index 250 kgm2 no chronic illness or medications that might affect glucose metabolism fasting glycemia100 mgdl HbA1c 57 39 mmolmol no positive islet autoantibodies HOMA-IR 25 Female participants pregnant at the time of study enrollment were not eligible
All procedures performed in this study were approved by the Institutional Research Committee of the University of Campania Luigi Vanvitelli All participants have provided written consent
Demographic and Clinical characteristics A brief schedule was specifically designed and completed by clinicians diabetologists or hematologists to record demographic and clinical data including age gender height weight duration of illness and other medical conditions family history of diabetes endocrine disorders cigarette smoking habit Finally the HOMA-IR was calculated as a parameter for evaluating insulin resistance Possible missing data was obtained by reviewing medical charts
Study design
All participants subjects and controls applied a Medtronic Guardian4 sensor for seven days At the end of the monitoring the glucose sensor data was analyzed using the Carelink System software
Glucose metrics considered for the analysis were glucose management indicator GMI mean glucose mgdl glycemic variability as standard deviation SD and coefficient of variation CV time spent with glycemia greater than or equal to 200 mg dl TAR200median time spent with blood glucose greater than or equal to 140 mgdl TAR140 median time spent with blood glucose less than 70 mgdl TBR70 median
As it is described in the American Diabetes Association ADA guidelines 2h-glucose value 140 mgdl 78 mmolL and 199 mgdl 11 mmoll during OGTT is diagnostic for prediabetes Moreover 2h glucose value 200 mgdl111 mmolL during OGTT or a random glucose value in any time of the day without regard to time since previous meal 200 mgdl111 mmolL are both diagnostic for diabetes mellitus
During a continuous glucose monitoring CGM it is not easy to understand correlation between glucose values and meals Furthermore in this study the evaluation of glucose values during CGM two hours after a controlled meal 75-g of oral glucose in OGTT was not performed Instead the participants glucose values were observed in real life Therefore although the number of participants who exceeded or equaled the value 140 mgdl or the value 200mgdl was recorded in addition how long these patients remained with glucose values above these cut-offs TAR140 TAR200was registered to make the observation of abnormal glycemic profiles more precise
Finally the value 6 of TAR 140was used as an index of normality as indicated in other studies on healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None