Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)
22 oktober 2022 uppdaterad av: Young Shin Song
Efficacy of Remote Intervention by Medical Staff Based on a Cloud System of Continuous Glucose Monitoring Data in Patients With Insulin-dependent Diabetes Using a Flash Sensor-based Glucose Monitoring (FSGM)
To investigate the efficacy of remote intervention by medical staff based on a cloud system of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash sensor-based glucose monitoring (FSGM).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
- Previous studies have been reported on the efficacy of CGM or FSGM and education on glucose control in insulin-dependent diabetes patients.
- This study aims to investigate whether it is more effective to receive remote intervention by medical staff based on a cloud system, than only to use FSGM and receive general education on FSGM.
- Trial design : parallel group, allocation ratio 1:1, a superiority study design
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Gyeonggi-do
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Seongnam, Gyeonggi-do, Korea, Republiken av, 13496
- CHA Bundang Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Men or women aged 19 to 75 years old
- Patients with type 1 diabetes
- Patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year
- Patients with HbA1c ≥ 7.0% at screening
- Patients willing to use a FSGM system
- Patients with informed consent
Exclusion Criteria:
- Gestational diabetes patients
- Patients within 1 year of diabetic diagnosis
- Patients taking drugs for severe cognitive impairment or psychiatric problems
- Patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test
- Patients with severe infection, before and after surgery, and severe trauma
- Patients on dialysis at the end of renal failure
- Patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records
- Pregnant or lactating women
- Participating in other clinical trials under R&D other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial
- Patients who are using a CGMS/FSGM or who have been using it within 12 weeks
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: No intervention by medical staff
The patients who start FSGM and receive general education on FSGM only.
|
|
|
Experimentell: Intervention by medical staff based on a cloud system
The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
|
Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system - Intervention contents
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in glycemic control measured by HbA1c
Tidsram: 3 months
|
Difference between baseline HbA1c and follow-up HbA1c
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in the time in range
Tidsram: 3 months
|
Difference in the duration of glucose values between 70 mg/dL and 180 mg/dL between baseline and the 3-month follow-up
|
3 months
|
|
Changes in the duration of hyperglycemic episodes
Tidsram: 3 months
|
Difference in the duration of hyperglycemic glucose values (>180, 250 mg/dL) (baseline vs. follow-up)
|
3 months
|
|
Changes in the duration of hypoglycemic episodes
Tidsram: 3 months
|
Difference in the duration of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
|
3 months
|
|
Changes in hypoglycemic episodes
Tidsram: 3 months
|
Difference between the frequency of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
|
3 months
|
|
Changes in the mean glucose values
Tidsram: 3 months
|
Difference in the mean glucose values (baseline vs. follow-up)
|
3 months
|
|
Changes in the frequency of use of trend arrows
Tidsram: 3 months
|
Difference in the frequency of use of trend arrows (baseline vs. follow-up)
|
3 months
|
|
Changes in the mean number of scans
Tidsram: 3 months
|
Difference in the mean number of scans per day (baseline vs. follow-up)
|
3 months
|
|
Changes in the insulin dose
Tidsram: 3 months
|
Difference in the insulin dose (baseline vs. follow-up)
|
3 months
|
|
Changes in the lipid parameter
Tidsram: 3 months
|
Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)
|
3 months
|
|
Changes in blood pressure
Tidsram: 3 months
|
Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)
|
3 months
|
|
Changes in body weight
Tidsram: 3 months
|
Difference in body weight (baseline vs. follow-up)
|
3 months
|
|
Lifestyle changes in diet
Tidsram: 3 months
|
Difference in the average number of meals and snacks per day (baseline vs. follow-up)
|
3 months
|
|
Lifestyle changes in the number of exercises
Tidsram: 3 months
|
Difference in the average number of exercises per week (baseline vs. follow-up)
|
3 months
|
|
Lifestyle changes in the duration of exercises
Tidsram: 3 months
|
Difference in the average duration of exercises per week (baseline vs. follow-up)
|
3 months
|
|
Changes in the patient absolute satisfaction with treatment assessed by questionnaires
Tidsram: 3 months
|
Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)
|
3 months
|
|
Changes in the patient relative satisfaction with treatment assessed by questionnaires
Tidsram: 3 months
|
Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)
|
3 months
|
|
Changes in depression assessed by questionnaires
Tidsram: 3 months
|
Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)
|
3 months
|
|
Changes in anxiety assessed by questionnaires
Tidsram: 3 months
|
Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)
|
3 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group; CDE10. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.
- Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.
- Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 juni 2021
Primärt slutförande (Faktisk)
30 april 2022
Avslutad studie (Faktisk)
30 april 2022
Studieregistreringsdatum
Först inskickad
24 maj 2021
Först inskickad som uppfyllde QC-kriterierna
22 juni 2021
Första postat (Faktisk)
23 juni 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 oktober 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 oktober 2022
Senast verifierad
1 oktober 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021-03-032-001
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