evaluating a digital intervention for alleviating diabetes-specific emotional distress in adults living with t2dm

Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus); Metabolic Disease; Endocrine System Diseases; Diabetes Mellitus, Type 2

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 one's 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 1:1 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.


Eligibility criteria:
inclusion criteria: * male, female or non-binary * age ≥ 18 years * diagnosis of t2dm secured via submission of a medical certificate attesting to the presence of at least one of the following icd-10-gm diagnoses of t2dm: e11.20, e11.30, e11.40, e11.50, e11.60, e11.72, e11.74, e11.80, e11.90 * elevated levels of diabetes-specific emotional distress: cut-off ≥ 33 on the paid-20 * access to cgm-compatible smartphone * consent to participate * sufficient knowledge of the german language exclusion criteria: * diagnosis of type 1 diabetes mellitus (t1dm) * change in medication (type, frequency of use or dosage) within 4 weeks before the baseline visit or planned within the subsequent 6 months * recent or planned bariatric operation within 4 weeks before the baseline visit or within the subsequent 6 months * change in psychotherapeutic treatment within 4 weeks before the baseline visit or planned within the subsequent 6 months * current use of continuous glucose monitoring (cgm) as part of one's diabetes treatment * experiencing problems with the cgm sensor or insufficient cgm data quality at baseline (t0) (i.e., wearing the cgm sensor on less than 6 of 7 days, providing less than a minimum of 96 hours of glucose values, providing less than 24 hours overnight cgm data)

Keywords: type 2 diabetes covivio diabetes self-management digital health application