Type1diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMInimed 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.
Sponsors
Attikon Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c \< 12.5% 3. Age \>7years at the initiation of the system 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period 5. Clinically able to start the AHCL system 6. History of 3 clinic visits in the last year
Exclusion criteria
1\. Diabetic Ketoacidosis in the 6 months prior to screening visits \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hba1c | Baseline, 3 months | Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G |
| Changes in TIR | Baseline, 3 months | Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G |
| Changes in TBR | Baseline, 3 months | Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G |
| Changes in TAR | Baseline, 3 months | Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G |
| Changes in bolus doses | Baseline, 3 months | Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G |
| Changes in basal doses | Baseline, 3 months | Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G |
| Changes in autocorrection doses | Baseline, 3 months | Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G: |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in endothelial glycocalyx thickness (μm) | Baseline, 6 months, 12 months | Changes in endothelial glycocalyx thickness at baseline and at 6 and 12 months after the initiation of MiniMed 780G |
| Changes in Ε score (Kpa) | Baseline, 6 months, 12 months | 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). |
| Changes in pulse wave velocity(m/s) | Baseline, 6 months, 12 months | Changes in pulse wave velocity at baseline and at 6 and 12 months after the initiation of MiniMed 780G |
| Changes in global longidutinal strain (%) | Baseline, 6 months, 12 months | Changes in global longidutinal strain at baseline and at 6 and 12 months after the initiation of MiniMed 780G |
| Changes in CAP (dB/m) | Baseline, 6 months, 12 months | 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). |
| Changes in gut microbioma | Baseline,3 months | Changes in gut microbioma at baseline and at 3 months after the initiation of MiniMed 780G. |
| Changes in coronary flow reserve | Baseline, 6 months, 12 months | Changes in coronary flow reserve at baseline, at six months and at 12 months after the initiation of MiniMed 780G. |
| Changes in central aortic blood pressure (mmHg) | Baseline, 6 months, 12 months | Changes in central aortic blood pressure at baseline and at 6 and 12 months after the initiation of MiniMed 780G. |
Countries
Greece
Contacts
Primary ContactVAIA LAMBADIARI, Professor
Outcome results
None listed