Type1diabetesNCT06646107
Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
An observational study of Type1diabetes, run by Attikon Hospital at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- MInimed 780G
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 240 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2025to 31 Jan 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
- Clinically able to start the AHCL system
- History of 3 clinic visits in the last year
Who cannot join
- 1. Diabetic Ketoacidosis in the 6 months prior to screening visits
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Attikon University General Hospital
Chaïdári, 124 62
Vaia Lambadiari, Professor, 2105831148, vlambad@otenet.gr
About this study
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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- MInimed 780G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MInimed 780GDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes Mellitus | patients aged >12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G Receives: Device: MInimed 780G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hba1c
Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G
Measured: Baseline, 3 months
Changes in TIR
Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G
Measured: Baseline, 3 months
Changes in TBR
Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G
Measured: Baseline, 3 months
Changes in TAR
Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G
Measured: Baseline, 3 months
Changes in bolus doses
Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G
Measured: Baseline, 3 months
Changes in basal doses
Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G
Measured: Baseline, 3 months
Changes in autocorrection doses
Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G:
Measured: Baseline, 3 months
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Mar 2025
- Primary completion31 Aug 2025
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646107
- Sponsor's protocol ID
- MED_TYPE 1
- Status last verified
- Nov 2025
- First submitted
- 13 Oct 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
- ClinicalTrials.gov ID
- NCT06646107
- Acronym / sponsor ID
- MED_TYPE 1
- Conditions
- Type1diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Mellitus | – | Device: MInimed 780Gpatients aged >12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
- Clinically able to start the AHCL system
Key exclusion criteria (2 listed)
- 1. Diabetic Ketoacidosis in the 6 months prior to screening visits
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MInimed 780GMinimed 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. | Device | Type 1 Diabetes Mellitus |
Primary outcome
Changes in Hba1c
Time frame: Baseline, 3 months
Differences in HbA1c at baseline and 3 months after the initiation of MiniMed 780G
Changes in TIR
Time frame: Baseline, 3 months
Changes in TIR at baseline and 3 months after the initiation of MiniMed 780G
Changes in TBR
Time frame: Baseline, 3 months
Changes in TBR at baseline and 3 months after the initiation of MiniMed 780G
Changes in TAR
Time frame: Baseline, 3 months
Changes in TAR at baseline and 3 months after the initiaton of MiniMed 780G
Changes in bolus doses
Time frame: Baseline, 3 months
Changes in bolus dosed at baseline and 3 months after the initiation of MiniMed 780G
Changes in basal doses
Time frame: Baseline, 3 months
Changes in basal doses at baseline and 3 months after the initiation of MiniMed 780G
Changes in autocorrection doses
Time frame: Baseline, 3 months
Changes in autocorrection doses between baseline and 3 months after the initiation of MiniMed 780G:
8 secondary outcomes
Changes in pulse wave velocity(m/s)
Time frame: Baseline, 6 months, 12 months
Changes in endothelial glycocalyx thickness (μm)
Time frame: Baseline, 6 months, 12 months
Changes in global longidutinal strain (%)
Time frame: Baseline, 6 months, 12 months
Changes in CAP (dB/m)
Time frame: Baseline, 6 months, 12 months
Changes in gut microbioma
Time frame: Baseline,3 months
Changes in coronary flow reserve
Time frame: Baseline, 6 months, 12 months
Changes in central aortic blood pressure (mmHg)
Time frame: Baseline, 6 months, 12 months
Changes in Ε score (Kpa)
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VAIA LAMBADIARI, Professor (2105831148, vlambad@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hba1c (time frame: Baseline, 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.