N/A Completed N=172 Randomized Single-blind Prevention

Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19

Type 2 Diabetes Mellitus · Covid19

Source: ClinicalTrials.gov NCT04591015 ↗

Enrolled (actual)

172

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcomePrimary: Hospital Readmission Rate Within 30 Days of Discharge — 24; 13 Participants — p=0.0626

Summary

The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospital Readmission Rate Within 30 Days of Discharge	24; 13	0.0626
PRIMARY Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days	-2.69; -1.45	0.0496 sig
PRIMARY Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days	-2.03; -0.91	0.0651
SECONDARY Hospital Readmission Rate Within 90 Days of Discharge	32; 30	0.8739
SECONDARY Diabetes Distress Scale - Change From Baseline to 90 Days	-0.42; -0.31	0.4702
SECONDARY Diabetes Distress Scale - Change From Baseline to 180 Days	-0.56; -0.35	0.1258
SECONDARY Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days	0.99; 1.06	0.8635
SECONDARY Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days	1.77; 0.47	0.0471 sig
SECONDARY Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days	3.08; 1.64	0.0218 sig
SECONDARY Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days	1.08; 0.82	0.5090
SECONDARY Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days	1.89; 1.33	0.4034
SECONDARY Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days	2.38; 0.76	0.0175 sig
SECONDARY COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge	5; 2	0.4435
SECONDARY COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge	8; 4	0.7417
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days	0.87; 0.55	0.5779
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days	0.91; -0.16	0.0493 sig
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days	1.59; 0.38	0.0773
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days	0.81; -0.21	0.0921
SECONDARY Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days	-0.64; -0.29	0.2404
SECONDARY Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days	-0.48; -0.52	0.8955

Eligibility Criteria

Inclusion Criteria

Are a patient admitted to a Scripps Mercy Hospital,
Consider yourself Hispanic/Latino, of any race
Are 18 years of age or older,
Speak English or Spanish,
Have type 2 diabetes and A1c ≥ 7% in the last 90 days, and
Have a cellphone that can receive/send text messages.

Exclusion Criteria

Are pregnant,
Are currently participating in another diabetes or COVID-19 related study, or
Do not meet all eligibility inclusion criteria.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04591015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.