Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529965
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With Type 2 Diabetes Mellitus Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
EASE-T2DM
Brief Summary:
This randomized controlled trial RCT with 250 patients suffering from type 2 diabetes mellitus T2DM aims to investigate the effectiveness of the self-guided digital therapeutic covivio Inclusion criteria are male female or non-binary age 18 years confirmed diagnosis of T2DM elevated levels of diabetes-specific emotional distress Problem Areas in Diabetes PAID-20 score 33 consent to participate sufficient German language skills Exclusion criteria are a diagnosis of type 1 diabetes mellitus T1DM current use of continuous glucose monitoring CGM as part of ones diabetes treatment changes or planned changes in medication within 4 weeks before the baseline visit or in the subsequent 6 months a bariatric operation within 4 weeks before the baseline visit or such an operation planned in the subsequent 6 months changes or planned changes in psychotherapeutic treatment within 4 weeks before the baseline visit or in the subsequent 6 months In addition participants will be excluded from the study if they did not wear the CGM sensor for at least 6 of 7 days at baseline before randomization providing a minimum of 96 hours of glucose values including at least 24 hours overnight
Patients will be randomized and allocated in a 11 ratio to either an intervention group in which they will receive access to covivio in addition to treatment as usual TAU n 125 or to a control group in which they will receive only TAU n 125
Co-primary endpoints of this trial will be the between-groups difference in the PAID-20 total score in the intervention and control group at six months adjusted for the PAID-20 baseline score as well as the glucose management indicator estimated HbA1c assessed using continuous glucose monitoring devices for a period of 7 days at six months adjusted for the baseline score
Secondary endpoints will be diabetes self-management skills body mass index BMI and quality of life
Patients will be randomized and allocated in a 11 ratio to either an intervention group in which they will receive access to covivio in addition to treatment as usual TAU n 125 or to a control group in which they will receive only TAU n 125
Co-primary endpoints of this trial will be the between-groups difference in the PAID-20 total score in the intervention and control group at six months adjusted for the PAID-20 baseline score as well as the glucose management indicator estimated HbA1c assessed using continuous glucose monitoring devices for a period of 7 days at six months adjusted for the baseline score
Secondary endpoints will be diabetes self-management skills body mass index BMI and quality of life
Detailed Description:
None
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