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NCT04335513: TESS
Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D
NA trial testing Early CGM-guided education and initiation of insulin therapy. in Type 1 Diabetes in 84 participants. Status unknown.
31 July 2023
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 30 April 2020 |
| Primary completion | 31 July 2023 |
| Estimated completion | 31 July 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Early CGM-guided education and initiation of insulin therapy.
- Usual care: glucometer surveillance and basic education.
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
- Prediabetic State — all drugs for Prediabetic State →
- Dysglycemia — all drugs for Dysglycemia →
- Autoimmune Diabetes — all drugs for Autoimmune Diabetes →
Sponsor
University of Colorado, Denver
Who can join
Adults 2 to 20, any sex, with Type 1 Diabetes or Prediabetic State. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04335513
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04335513 (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 Colorado, Denver
- Last refreshed: 9 May 2022
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/NCT04335513.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing