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NCT04420845
Diabetes Self-Management Education with Sleep Hygiene
NA trial testing Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES) in Diabetes Mellitus, Type 2. Withdrawn.
25 March 2022
Quick facts
| Lead sponsor | University of Arkansas |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Start date | 25 March 2022 |
| Primary completion | 25 March 2022 |
| Estimated completion | 25 March 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Sleep Hygiene — all drugs for Sleep Hygiene →
Sponsor
University of Arkansas
Who can join
18 and older, any sex, with Diabetes Mellitus, Type 2 or Sleep Hygiene. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will test whether adding sleep hygiene education and support to diabetes self-management education and support (DSMES) in diverse patients (African American, Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this study are: * Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by the HbA1c test in diverse adults with T2DM. * Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life in diverse adults with T2DM. * Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with diverse adults with T2DM. * Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in Regional Programs clinics.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04420845
- Europe PMC full search
- ASCO Meeting Library
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Other University of Arkansas trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04420845 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arkansas
- Last refreshed: 3 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04420845.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing