An observational study in Type1diabetes, sponsored by Attikon Hospital. Recruiting at 1 site in Greece. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Attikon Hospital · Observational
In this observaltional study, 240 patients aged >12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system will be included.We aim to compare patients' adherence to Mediterranean diet (MD) before and 12 weeks after initiation of MiniMed 780G and its association with CGM and insulin metrics, as well as anthropometric measurements, BMI, body composition, lipid levels, blood pressure and gut microbioma. Moreover, at baseline, at six and 12 months, markers of endothelial and cardiovascular function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.
This observational study will include 240 participants (80 participants per country) from IGI region (Italy, Greece and Israel), children adolescents and young adults (12> years old) with T1D that are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system. After a 7-day run-in period, participants will be evaluated with food intake log and adherence to Meditteranean Diet (MD) with PREDIMED questionnaire. One hour session on MD and healthy impact on Diabetes will be provided to all participants and will be assigned to initiate MiniMed 780G and followed for 12 weeks. HbA1c, CGM and Insulin Metrics, anthropometric measurements, body composition, blood pressure and lipid leves as well a gut microbioma will be performed at baseline and 12 weeks, after MiniMed 780G initiation. A 7-day food diary logbook will be collected to identify the amount and type of the food at baseline and at the end of the study. At baseline, at 6 and at 12 months, markers of endothelial and cardiovascular function will also be assessed. An extension phase will include additional 3 and 6, which concludes one year of follow-up.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 240 is above the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Attikon Hospital is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
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Children adolescents and young adults (12> years old) with T1D that are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Diabetic Ketoacidosis in the 6 months prior to screening visits
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients aged \>12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G
Device: MInimed 780G
Minimed 780G HCL system (Metronic, Northridge, Ca, USA) is ConformitèEuropëenne(CE)-marked and includes additional functionality aiming to provide further protections from high glucose levels. When the system is used in Auto Mode automatically calculate the insulin dose based on information received from CGM. Signals are converted by the transmitter to sensor glucose values. Sensor values are then transmitted to the insulin pump. Sensor glucose and insulin delivery data are stored by the pump and may be uploaded. The HCL system can be programmed to automatically calculate insulin doses (both basal insulin and correction boluses) based on information received from CGM780G and the adherence to MD.
Changes in Hba1c
Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G
Time frame: Baseline, 3 months
Changes in TIR
Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G
Time frame: Baseline, 3 months
Changes in TBR
Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G
Time frame: Baseline, 3 months
Changes in TAR
Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G
Time frame: Baseline, 3 months
Changes in bolus doses
Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G
Time frame: Baseline, 3 months
Changes in basal doses
Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G
Time frame: Baseline, 3 months
Changes in autocorrection doses
Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G:
Time frame: Baseline, 3 months
Changes in pulse wave velocity(m/s)
Changes in pulse wave velocity at baseline and at 6 and 12 months after the initiation of MiniMed 780G
Time frame: Baseline, 6 months, 12 months
Changes in endothelial glycocalyx thickness (μm)
Changes in endothelial glycocalyx thickness at baseline and at 6 and 12 months after the initiation of MiniMed 780G
Time frame: Baseline, 6 months, 12 months
Changes in global longidutinal strain (%)
Changes in global longidutinal strain at baseline and at 6 and 12 months after the initiation of MiniMed 780G
Time frame: Baseline, 6 months, 12 months
Changes in CAP (dB/m)
Changes in liver steatosis at baseline and at 6 and 12 months after the initiation of MiniMed 780G as assessed by the measurement of CAP. CAP score will be used as an index of liver fat content, with normal values being \< 238 dB/m. \<237 dB/m (S0, no steatosis), 237 -259 dB/m (S1, mild steatosis), 259 -291 dB/m (S2, moderate steatosis), and 291 -400 dB/m (S3,severe steatosis). E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) \<5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) \>16.0 kPa (F4, cirrhosis).
Time frame: Baseline, 6 months, 12 months
Changes in gut microbioma
Changes in gut microbioma at baseline and at 3 months after the initiation of MiniMed 780G.
Time frame: Baseline,3 months
Changes in coronary flow reserve
Changes in coronary flow reserve at baseline, at six months and at 12 months after the initiation of MiniMed 780G.
Time frame: Baseline, 6 months, 12 months
Changes in central aortic blood pressure (mmHg)
Changes in central aortic blood pressure at baseline and at 6 and 12 months after the initiation of MiniMed 780G.
Time frame: Baseline, 6 months, 12 months
Changes in Ε score (Kpa)
Changes in liver steatosis at baseline and at 6 and 12 months after the initiation of MiniMed 780G as assessed by E score. E score will be used as an index of liver fibrosis. The cut-off values for fibrosis (F) were as follows:(1) \<5.5 kPa (F0, no fibrosis), (2) 5.5-8.0 kPa (F1, mild fibrosis), (3) 8.0-10.0 kPa (F2, moderate fibrosis),(4) 11.0-16.0 kPa (F3, severe fibrosis), and (5) \>16.0 kPa (F4, cirrhosis).
Time frame: Baseline, 6 months, 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Aug 2025, 5 months.
Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's 5 months is below that.
Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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Attikon Hospital