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Diabetes Type 1780G65+NCT06207838

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

A study testing MiniMed 780G system in people with Diabetes Type 1, run by Jagiellonian University at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Diabetes Type 1
What is being tested?
MiniMed 780G system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePoland
Study dates
14 Sep 2023to 31 Dec 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age over 65 years
  • T1DM
  • Willing to participate in a study for the specified duration
  • Willing to perform ≥ 4 finger stick blood glucose measurements daily
  • Willing to wear the system continuously throughout the study
  • Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
Show all 9Show fewer
  • Treated with MDI/CSII (with exclusion of 780G)
  • Willing to perform at least 4 BGM/day, when on MDI/CSII
  • Lack of advanced complications of diabetes, eGFR>30

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Hospital University; Jagiellonian University Medical College

    Krakow, 30688

Other trials in Poland

About this study

Official title: 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

Read the 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

Conditions
Diabetes Type 1
Being tested
MiniMed 780G system
Keywords
AHCL, Insulin pump therapy, Multiple daily injection, QoL
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • MiniMed 780G systemDevice

    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.

Study groups in NCT06207838
Study groupRoleWhat they receive
Actual therapyNo interventionThe patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures
Advanced Hybrid Cloosed Loop SystemExperimentalThe patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system
Receives: Device: MiniMed 780G system

What is being measured

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

  1. 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).

    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).

    Measured: Month 12

Secondary outcomes (13)

  1. Between groups difference in the percentage of participants achieving TIR >70%

    Between groups difference in the percentage of participants achieving TIR >70%

    Measured: Month 12

  2. Between group difference in the percentage of time spent in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L)

    Between group difference in the percentage of time spent with SG > 250 mg/dL (13.9 mmol/L)

    Measured: Month 12

  3. Between group difference in the percentage of time spent in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L)

    Between group difference in the percentage of time spent with SG > 180 mg/dL (10.0 mmol/L)

    Measured: Month 12

  4. Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)

    Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)

    Measured: Month 12

  5. Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)

    Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)

    Measured: Month 12

  6. QoL group difference using: The World Health Organisation- Five Well-Being Index (WHO-5)

    QoL group difference (WHO-5): Final score: 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

    Measured: Month 12

  7. Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry

    Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry

    Measured: Month 12

  8. Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation

    Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation

    Measured: Month 12

  9. Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness

    Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness,

    Measured: Month 12

  10. Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test

    Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test (units distance in meters, higher value mean a better outcome)

    Measured: Month 12

  11. Difference in physical capacity indices listed in screening visit: Fried Scale

    Difference in physical capacity indices listed in screening visit: Fried Scale (higher scores mean a worse outcome, score >3 frail present)

    Measured: Month 12

  12. Difference in physical capacity indices listed in screening visit: Berg Balance Scale

    Difference in physical capacity indices listed in screening visit: Berg Balance Scale (higher score mean a better outcome)

    Measured: Month 12

  13. Difference in physical capacity indices listed in screening visit: Four Square Step

    Difference in physical capacity indices listed in screening visit:Four Square Step (units time, shorter time means better outcome)

    Measured: Month 12

Timeline

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

  1. First posted17 Jan 2024
  2. Study start14 Sep 2023
  3. Primary completion7 Sep 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

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
Model description
The trial is a two-centers, randomized controlled, parallel group study
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207838
Sponsor's protocol ID
1072.61201.5.2023
Acronym
780G65+
Status last verified
Jan 2024
First submitted
16 May 2023
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matejko B, Cyranka K, Sudul P, Susul K, Krezel J, Chernovol J, Maga P, Malecki MT, Klupa T. Metabolic and vascular outcomes after transition to the MiniMed 780G system in adults >/=65 years with type 1 diabetes: a randomised, single-centre study. Diabetologia. 2026 Sep;69(9):2421-2431. doi: 10.1007/s00125-026-06780-9. Epub 2026 Jun 25.

    PubMed 42347980

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed 780G system in people with Diabetes Type 1, run by Jagiellonian University at 1 site in Poland.

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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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 Poland. 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?

Results are not available in the source record.

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?

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). 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 NCT06207838, which also lists 1 linked publication.

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 17 Jan 2024.

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