NCT05756829Toboroz
Type 1 Diabetes Virtual Self-management Education and Support
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 21.
Rövid összefoglaló (regiszter, angolul)
OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario. INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 580 (tervezett)
- Első benyújtás
- 2023. febr. 9.
- Kezdés
- 2023. máj. 10.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- Unity Health Toronto
- Betegségek
- 1-es típusú cukorbetegség
- NCT-szám
- NCT05756829
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 580
- 2023. máj. 10. és az elsődleges befejezés (2026. dec. 31.) között
- 9 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Diagnosed with non-Type 1 diabetes
Egyéb
- Unable to use a computer/tablet or mobile phone
- Pregnant
- On dialysis
- Unable to fluently speak or read English (self-reported)
Kiket keres a vizsgálat
- Outpatients ≥18 years of age
- Physician diagnosis of type 1 diabetes
- Currently on an insulin pump or using multiple daily insulin injections.
- HbA1c ≥ 7.5% on most recent laboratory report or estimated from CGM/FGM* report, within the last 4 months
- *14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)
- Has access to a mobile device or computer/tablet with a video camera
- Seen for at least one visit in the previous 6 months by participating certified diabetes educator at the selected diabetes clinic OR If a transitioning patient: Currently enrolled in a diabetes program below AND had at least one visit or touch-point prior in the previous 6 months by participating certified diabetes educator at on of our participating diabetes clinics
- OHIP coverage
- Currently using an active email address or be willing to obtain an email address
- Has consistent and reliable access to internet
- Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (9)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Waterloo Regional Health Network | Kitchener | Kanada | Toboroz |
| Mackenzie Health | Richmond Hill | Kanada | Toboroz |
| Mount Sinai Hospital | Toronto | Kanada | Toboroz |
| Women's College Hospital | Toronto | Kanada | Toborzás még nem indult |
| St. Michael's Hospital, Unity Health Toronto | Toronto | Kanada | Toboroz |
| Sunnybrook Health Sciences Centre | Toronto | Kanada | Toboroz |
| Toronto General Hospital | Toronto | Kanada | Toboroz |
| St. Joseph's Health Centre, Unity Health Toronto | Toronto | Kanada | Toboroz |
| Charles H. Best Diabetes Centre | Whitby | Kanada | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.