NCT07097818Toboroz
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 3. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
The GLITTER Study 2 is a cluster randomized trial that will evaluate the impact of comprehensive and intensive management, comprising a team, technology, education, and peer resources, on metabolic control and psychological outcomes in patients with type 1 diabetes.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 400 (tervezett)
- Első benyújtás
- 2025. júl. 24.
- Kezdés
- 2025. aug. 18.
- Elsődleges befejezés
- 2027. márc. 1.
- Fő szponzor
- Second Xiangya Hospital of Central South University
- NCT-szám
- NCT07097818
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 400
- 2025. aug. 18. és az elsődleges befejezés (2027. márc. 1.) között
- 10 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
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.
- Patients who have received red blood cell transfusions or erythropoiesis-stimulating agents within 3 months prior to screening.
- Patients who have used any oral, injectable, or intravenous corticosteroids within 8 weeks prior to screening, or who plan to use corticosteroids during the trial.
- Patients with alcohol or drug abuse.
- Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period.
- Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks.
Más betegség
- Patients who plan to receive diabetes treatment at other hospitals.
- Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies.
- Patients diagnosed with hematologic or bleeding disorders.
- Patients who, in the investigator's opinion, are not suitable for participation in this clinical trial, such as those with a history of vision impairment, eating disorders, celiac disease, etc.
Laborértékek
- Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.
- Patients with severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches.
Egyéb
- Patients with auditory or visual impairments.
- Patients who plan to receive blood transfusions during the study period.
- Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding.
A regiszterben nem jelölt feltételek
- Eligibility criteria for study hospitals:
- Members of the China Diabetes Type 1 Study (CD1S).
- Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once.
- Have type 1 diabetes educators.
- Eligibility criteria of study participants:
- Diagnosis of Type 1 Diabetes.
- Age ≥6 years, regardless of gender.
- Duration of disease >3 months.
- Planned to attend follow-up visits at this hospital within the next year.
- Possess sufficient cognitive ability to operate all study-related devices.
- Willing to use continuous glucose monitoring and insulin pumps, upload data, and participate in remote monitoring.
- Willing to attend structured education sessions and camp activities on time (for the intervention group only).
- Willing and able to adhere to the study protocol.
- Willing to sign the informed consent form.
Életkor a regiszterben: 6 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (10)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Department of Endocrinology and Metabolism, Peking University People's Hospital | Beijing | Kína | Toborzás még nem indult |
| Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University | Changsha | Kína | Toboroz |
| Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University | Chengdu | Kína | Toborzás még nem indult |
| Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health | Hangzhou | Kína | Toborzás még nem indult |
| Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology | Luoyang | Kína | Toboroz |
| Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University | Quanzhou | Kína | Toborzás még nem indult |
| Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University | Shenyang | Kína | Toborzás még nem indult |
| Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University | Shenzhen | Kína | Toborzás még nem indult |
| Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital | Tangshan | Kína | Toborzás még nem indult |
| Department of Endocrinology, Zhongnan Hospital of Wuhan University | Wuhan | Kína | Toborzás még nem indult |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.