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

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: Enrolling by invitation
• Conditions: Diabetes Type 1
• Intervention / Treatment: Device: MiniMed 780G system

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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).	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

Outcome Measure	Measure Description	Time Frame
Between groups difference in the percentage of participants achieving TIR >70%	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)	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)	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)	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)	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)	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	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	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	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	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	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	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	Difference in physical capacity indices listed in screening visit:Four Square Step (units time, shorter time means better outcome)	Month 12

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Tomasz Klupa, Prof., Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): September 7, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: QoL; Insulin pump therapy; Multiple daily injection; AHCL
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID 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