Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump (780G65+)

January 12, 2024 updated by: Tomasz Klupa, Jagiellonian University

Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump: the Impact on Glucose Patterns, Quality of Life Physical & Cognitive Measures, as Well as Vascular Status

Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including advanced hybrid closed loop (HCL) insulin pumps. The results of the AHCL insulin pump based studies published so far are very encouraging, including that Medtronic-sponsored study performed at our center "Transition of CSII/CGM naïve patients directly into AHCL (780G) insulin pump: the impact on glucose patterns and quality of life measures" (1-6). Unfortunately there is little data concerning the usage of AHCL systems in older patients. The management of these individuals is particularly challenging as older adults with type 1 diabetes are especially vulnerable to hypoglycaemia. The recent ADA/EASD consensus underlines that the use of advanced technologies in older individuals is useful and should not be discontinued or a priori excluded because of the older age (7). Since the AHCL systems are very effective in hypoglycemia prevention they could be considered the treatment of choice in older patients with T1DM. The open question is how effectively would older individuals adopt this advanced technology, how would they accept it, and if the simplicity in terms of everyday usage of AHCL versus less advanced technologies would be appreciated by older individuals with T1DM. Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices

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.
30

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 Locations

  • Poland
      • Krakow, Poland, 30688
        • Hospital University; Jagiellonian University Medical College

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age over 65 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
  5. Willing to wear the system continuously throughout the study
  6. Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
  7. Treated with MDI/CSII (with exclusion of 780G)
  8. Willing to perform at least 4 BGM/day, when on MDI/CSII
  9. Lack of advanced complications of diabetes, eGFR>30

Exclusion Criteria:

  1. Severe concurrent illness
  2. Laboratory abnormalities, or medications that might affect study participation,
  3. Severe renal impairment (eGFR<30)

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: None (Open Label)

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.
No Intervention: Actual therapy
The patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures
Experimental: Advanced Hybrid Cloosed Loop System
The patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system
Device: MiniMed 780G system
The MiniMed™ 780G system automatically adjust insulin delivery to patient needs for an easier way to stabilise glucose levels. It features an advance level of automation for diabetes management, known as SmartGuard™ technology. If patient glucose levels are trending high, it gives patient more insulin. Technology is CE marked.

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
Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L).
Time Frame: Month 12
Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L).
Month 12

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
Between groups difference in the percentage of participants achieving TIR >70%
Time Frame: Month 12
Between groups difference in the percentage of participants achieving TIR >70%
Month 12
Between group difference in the percentage of time spent in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L)
Time Frame: Month 12
Between group difference in the percentage of time spent with SG > 250 mg/dL (13.9 mmol/L)
Month 12
Between group difference in the percentage of time spent in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L)
Time Frame: Month 12
Between group difference in the percentage of time spent with SG > 180 mg/dL (10.0 mmol/L)
Month 12
Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)
Time Frame: Month 12
Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)
Month 12
Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)
Time Frame: Month 12
Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)
Month 12
QoL group difference using: The World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame: Month 12
QoL group difference (WHO-5): Final score: 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Month 12
Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry
Time Frame: Month 12
Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry
Month 12
Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation
Time Frame: Month 12
Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation
Month 12
Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness
Time Frame: Month 12
Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness,
Month 12
Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test
Time Frame: Month 12
Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test (units distance in meters, higher value mean a better outcome)
Month 12
Difference in physical capacity indices listed in screening visit: Fried Scale
Time Frame: Month 12
Difference in physical capacity indices listed in screening visit: Fried Scale (higher scores mean a worse outcome, score >3 frail present)
Month 12
Difference in physical capacity indices listed in screening visit: Berg Balance Scale
Time Frame: Month 12
Difference in physical capacity indices listed in screening visit: Berg Balance Scale (higher score mean a better outcome)
Month 12
Difference in physical capacity indices listed in screening visit: Four Square Step
Time Frame: Month 12
Difference in physical capacity indices listed in screening visit:Four Square Step (units time, shorter time means better outcome)
Month 12

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.
Jagiellonian University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tomasz Klupa, Prof., Jagiellonian University

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.
September 14, 2023

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.
September 7, 2024

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.
December 31, 2024

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).
May 16, 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 12, 2024

First Posted (Actual)

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.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

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.
January 17, 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 12, 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.
  • 1072.61201.5.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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