Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference

ConditionType1diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-80
SponsorAttikon Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

HbA1c < 12.5%

Age >7years at the initiation of the system

Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MInimed 780G

    Device

    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.

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: Type 1 Diabetes Mellitus1 intervention

Trial outcomes

Primary outcomes

1

Changes in Hba1c

Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G

Time frame
Baseline, 3 months
2

Changes in TIR

Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G

Time frame
Baseline, 3 months
3

Changes in TBR

Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G

Time frame
Baseline, 3 months
4

Changes in TAR

Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G

Time frame
Baseline, 3 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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