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

NCT06207838 | Unknown

• 1 other identifier: 1072.61201.5.2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 physical capacity indices

Conditions

Diabetes Type 1

Keywords

AHCL; Insulin pump therapy; Multiple daily injection; QoL

Outcome Measures

Primary Outcomes (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).

  Month 12

Secondary Outcomes (13)

• 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)

  Month 12

• Between group difference in the percentage of time spent in hyperglycemic range 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)

  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

Study Arms (2)

Actual therapy

NO INTERVENTION

The patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures

Advanced Hybrid Cloosed Loop System

EXPERIMENTAL

The patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system

Device: MiniMed 780G system

Interventions

MiniMed 780G system DEVICE

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.

Advanced Hybrid Cloosed Loop System

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Willing to perform at least 4 BGM/day, when on MDI/CSII
• Lack of advanced complications of diabetes, eGFR\>30

You may not qualify if:

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

Sponsors & Collaborators

• Jagiellonian University: lead
• Medtronic: collaborator

Study Sites (1)

Hospital University; Jagiellonian University Medical College

Krakow, 30688, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Tomasz Klupa, Prof.

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Tomasz Klupa

Model Details: The trial is a two-centers, randomized controlled, parallel group study

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: January 17, 2024
• Study Start: September 14, 2023
• Primary Completion: September 7, 2024
• Study Completion: December 31, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)