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

January 23, 2024 updated by: Dr. Tali Cukierman-Yaffe, Sheba Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tali Cukierman-Yaffe, Professor
  • Phone Number: 0523824704
  • Email: tcukierm@gmail.com

Study Locations

  • Israel
      • Ramat-Gan, Israel, 52621
        • Recruiting
        • Sheba Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe concurrent illness
  2. Laboratory abnormalities, or medications that might affect study participation,
  3. Severe renal impairment
  4. Any illness that may interfere with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AHCL group
Participants 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.
Device: MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system
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.
Placebo Comparator: MDI/CSII group
The 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.
Other: MDI/CSII
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement of glucose measures in older individuals
Time Frame: 12 months

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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time up and go
Time Frame: 12 months
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.
12 months
6 minute walk
Time Frame: 12 months
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.
12 months
Four Square Step Test (FSST)
Time Frame: 12 months
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.
12 months
Grip strength
Time Frame: 12 months
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.
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fried scale
Time Frame: 12 months

Fried scale criteria is used for identifying frailty in older people. Frailty is defined as the presence of at list three components. i. Weight loss: More then 10 pounds unintentional weight loss in the past year (not due to dieting or exercise).

ii. Poor endurance and energy: as indicated by self-report of exhaustion. Self-report exhaustion, identified by two questions from the CES-D scale.

iii. Low Physical Activity level: kilocalories expended per week, calculated adjusted according to age and gender.

iv. Walk time: over seven seconds to pass three meters
12 months
Moca
Time Frame: 12 months
Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA), a rapid screening tool for mild cognitive dysfunction. It assesses different cognitive domains such as: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. A MoCa score<21 was defined as severe cognitive impairment (probable dementia). A MoCA score between 21-25 was defined as mild cognitive impairment.
12 months
DSS
Time Frame: 12 months
The Digit Symbol Substitution Test (DSST): a subtest of the Wechsler Adult Intelligence Scale (3rd Edition) and pertains to a wide array of cognitive domains such as visual-motor speed and coordination, capacity for learning, attention, concentration and short term memory. The DSST gets a raw score between 0 and 90 which can then be converted to a standardized score with a mean score of 10 and a standard deviation of 3.
12 months
WHO-5
Time Frame: 12 months
The WHO-5 wellbeing questionnaire asses emotional status. Who 5 gets a raw score of 0 to 25 which is then multiplied by 4 to convert the score to a continuum between 0 (worst imaginable quality of life) to 100 (best imaginable quality of life). A score of ≤50 indicates poor wellbeing and suggests further investigation into possible symptoms of depression. A score of 28 or below is indicative of depression.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0205-23-SMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings