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Diabetes Mellitus, Type 1NCT06236256

Advanced Hybrid Closed Loop System (AHCL) in Older Patients With Type 1 Diabetes Mellitus

A study testing MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system and MDI/CSII in people with Diabetes Mellitus, Type 1, run by Sheba Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The trial is a randomized controlled, parallel group design study. Patients will be followed up during approximatively 12 months. Patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the advanced Hybrid Closed Loop system (AHCL) group which will be… Read more about this study

Who is it for?
Ages 60 to 120 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system and MDI/CSII
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteIsrael
Study dates
9 Jan 2024to 20 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 60 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 60 years
  • T1DM
  • Willing to participate in a study for the specified duration
  • Willing to perform ≥ 4 finger stick blood glucose measurements daily or connected to a "basket approved" CGM
  • Willing to wear the system continuously throughout the study
  • Treated with MDI/CSII (with exclusion of 780G or other hybrid closed systems)
  • Lack of advanced complications of diabetes

Who cannot join

  • Severe concurrent illness
  • Laboratory abnormalities, or medications that might affect study participation,
  • Severe renal impairment
  • Any illness that may interfere with study procedures

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba medical center

    Ramat Gan, Israel, 52621

Other trials in Israel

About this study

Official title: Advanced Hybrid Closed Loop System (780G) for People With Type 1 Diabetes Mellitus Patients Over the Age of 60: Efficacy in Improving Glucose Indices, Quality of Life, Cognitive Functions and Physical Capacity

The trial is a randomized controlled, parallel group design study. Patients will be followed up during approximatively 12 months.

Patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the advanced Hybrid Closed Loop system (AHCL) group which will be connected to the Minimed 780G system. .

At the end of the 12 month study period, we will evaluate whether the AHCL system improved glucose indices in older individuals with Type 1 diabetes mellitus (T1DM) and assess whether the ACHL treatment improved physical capacity, frailty \& sarcopenia indices as well as quality of life and cognitive functions.

Read the detailed description

All participants will go through a screening phase that includes an eligibility assessment, informed consent forms, Cognitive function assessment ( QoL questionnaire, WHO-5 questionnaire, MOCA, DSST, General Heath question), Sarcopenia/functional status/frailty assessment ( Timed up and Go , 6 min walk, 10 meter walk, Berg Balance Scale , Four Square Step Test , Grip Strength, 30 second chair stand, Fried Scale) and Lab tests.

After the screening, the participants will start a two week run in phase while continuing their routine procedures with an added unblinded G4 guardian standalone sensor.

sensor and data will be collected for 14 days and afterwards patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the AHCL group which will be connected to the Minimed 780G system. Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system. After 6 months, both groups will be connected to the standalone sensor and glucose data will be collected after 2 weeks.

After 12 months of the study period, all participants will undergo primary assessments, blood tests questionnaires and will finish their part in the study.

Being tested
MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system, MDI/CSII
Keywords
Older, Physical capacity, Frailty, Cognitive function
Medical subject headings
Diabetes Mellitus, Type 1, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) systemDevice

    The MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system consists of the following devices: MiniMed 780G insulin pump, Guardian Link (4) transmitter and the Guardian Sensor (4). It is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. Study participants will be connected to the system and glucose data will be collected throughout the 12 month study period.

  • MDI/CSIIOther

    Participants in the control group with continue their routine procedures that include eighter Multiple daily insulin injections (MDI) treatment or different kinds of Continuous subcutaneous insulin infusion (CSII) pumps depending on their treatment before the study. The participants will be connected to a standalone sensor at the start, middle and end of the study and glucose data will be collected.

Study groups in NCT06236256
Study groupRoleWhat they receive
AHCL groupExperimentalParticipants will be connected to the MiniMed 780G AHCL system for the 12 months study period. This group will have two additional visits to allow for patients to be trained on the AHCL system.
Receives: Device: MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system
MDI/CSII groupPlacebo comparatorThe patient will continue MDI/CSII treatment as per their routine procedures. At the beginning, middle and end of the stage they will be connected to a standalone sensor from which glucose data will be collected.
Receives: Other: MDI/CSII

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of glucose measures in older individuals

    The primary objective of this study is to evaluate whether the AHCL (MiniMed 780G) system improves glucose indices in older (above 60 years of age) individuals with Type 1 diabetes mellitus.

    Glucose differences between the groups will be monitored and evaluated by difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (Primary outcome), time in hyperglycemic range SG > 250 mg/dL , SG > 180 mg/dL, time in hypoglycemic range with SG < 70 mg/dL , SG < 54 mg/dL as well as difference in the glycemic variability, mean glucose level and change in HbA1c levels.

    Measured: 12 months

Secondary outcomes (4)

  1. Time up and go

    The test measures the ability of a person to: stand up, walk, turn around and sit down safely in a timely manner. The test examines most mobility skills. The participant is told to get up from a chair with handles, walks 3 meters, turns, walks back, and sit down again. The score is according to the length of time in seconds to complete the task. The score is categorized according to the risk for falls and independent walking. The following cut-offs are conventionally used: less than14 seconds = independent mobility; 15-20 seconds= semi-independent mobility may have a some what increased risk for falls \& needs further evaluation some may need a walking aid; 20-30 seconds= dependent mobility: need help walking, 50% with a cane, 40% walker, 10% supervision. Some will need help in transfers, and most will require help using the toilet.

    Measured: 12 months

  2. 6 minute walk

    The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The six minute walk distance in healthy adults has been reported to range from 400m to 700m. People with lower vs. higher scores on the 6 minute walk are at higher risk for falls, disability, frailty, hospitalization and death. There is no conventional cut offs, however as with other tests, severe impairment may be defined as two standard deviations below the norm.

    Measured: 12 months

  3. Four Square Step Test (FSST)

    The Four Square Step Test (FSST) evaluates dynamic balance in a high functional level and features walk forward backwards left and right above two, 90 cm and 2.5 cm high long sticks that divide the floor into four squares. The participant is stands in square 1 facing no. 2 square. The goal is to walk as quickly as possible in all the squares in the following order: from 1 to- 2,3,4,1,4,3,2 and 1 without touching the sticks. The score is the time required to complete the entire route. Sever physical impairment is considered less then 15 seconds, Mild physical impairment is considered 10.14- 14.59 seconds, intact physical impairment is considered less then 10.14 seconds.

    Measured: 12 months

  4. Grip strength

    The maximum grip strength is examined utilizing the Jammer dynamometer. The test is conducted in a neutral hand position and repeated three times. The score is the average strength in kg this is compared to the general population according to age and gender. There is no conventional cut offs, however as with other tests, severe impairment may be defined as two standard deviations below the norm.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start9 Jan 2024
  3. Primary completion20 Aug 2025
  4. Study completion20 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236256
Sponsor's protocol ID
0205-23-SMC
Status last verified
Jul 2026
First submitted
14 Nov 2023
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system and MDI/CSII in people with Diabetes Mellitus, Type 1, run by Sheba Medical Center at 1 site in Israel.

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 21 Jul 2026. 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 Israel. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of glucose measures in older individuals (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06236256.

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 21 Jul 2026.

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