Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

NCT05477030 | Unknown DMC

• 1 other identifier: 2022004
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.

Conditions

Type 1 Diabetes

Keywords

Automated insulin delivery; Type 1 Diabetes complications

Outcome Measures

Primary Outcomes (2)

• Time in glycemic range 70-180 mg/dl

  time spent by the patient in glucose range

  From Baseline to 26 weeks

• Glycated Hemoglobin (HbA1c)

  percentage of hemoglobin glycosylated

  From Baseline to 26 weeks

Secondary Outcomes (7)

• Early microangiopathic damage markers: sTNFR-1/2

  From Baseline to 26 weeks

• Early microangiopathic damage markers: B-2 microglobulin

  From Baseline to 26 weeks

• Early microangiopathic damage markers: cystatin C

  From Baseline to 26 weeks

• Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin

  From Baseline to 26 weeks

• Early microangiopathic damage markers: osteopontin

  From Baseline to 26 weeks

Study Arms (2)

Study Group A (Intervention)

ACTIVE COMPARATOR

Group treated with automated insulin delivery (advanced hybrid closed-loop)

Device: Medtronic MiniMed 780G with SmartGuard activation

Study Group B (Control)

ACTIVE COMPARATOR

Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)

Device: Medtronic MiniMed 780G without SmartGuard activation

Interventions

Medtronic MiniMed 780G with SmartGuard activation DEVICE

Insulin pump implemented with alghoritm for automatic modulation of insulin delivery (to increase time in glucose range 70-180 mg/dl)

Study Group A (Intervention)

Medtronic MiniMed 780G without SmartGuard activation DEVICE

Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)

Study Group B (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients
• T1D patients above 18 years in CSII treatment for at least 3 months
• HbA1c values between 6.0% and 9.5%
• Disease duration ≥ 2 years
• Written informed consent obtained from the patient

You may not qualify if:

• Pregnancy
• Participation to other clinical trials
• A history of alcohol or drug abuse
• Advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or eGFR \< 60 ml/min/1,73m2
• Proliferative Diabetic retinopathy or macular edema
• Established Atherosclerotic Cardiovascular Disease (ASCVD) or history of heart failure
• Presence of serious diseases or conditions which in the opinion of the Investigator makes patient non-eligible for the study
• Hypoglycemia Unawareness (Clarke score \> 4)
• Patients unable to understand spoken and written Italian language

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST FBF Sacco

Milan, 20157, Italy

RECRUITING

Related Publications (25)

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• Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med. 2008 Jul;25(7):765-74. doi: 10.1111/j.1464-5491.2008.02486.x.

  PMID: 18644063 RESULT

• Pankowska E, Blazik M, Dziechciarz P, Szypowska A, Szajewska H. Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials. Pediatr Diabetes. 2009 Feb;10(1):52-8. doi: 10.1111/j.1399-5448.2008.00440.x. Epub 2008 Aug 27.

  PMID: 18761648 RESULT

• EQuality1 Study Group--Evaluation of QUALITY of Life and Costs in Diabetes Type 1; Nicolucci A, Maione A, Franciosi M, Amoretti R, Busetto E, Capani F, Bruttomesso D, Di Bartolo P, Girelli A, Leonetti F, Morviducci L, Ponzi P, Vitacolonna E. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet Med. 2008 Feb;25(2):213-20. doi: 10.1111/j.1464-5491.2007.02346.x. Epub 2008 Jan 14.

  PMID: 18201210 RESULT

• Maniatis AK, Toig SR, Klingensmith GJ, Fay-Itzkowitz E, Chase HP. Life with continuous subcutaneous insulin infusion (CSII) therapy: child and parental perspectives and predictors of metabolic control. Pediatr Diabetes. 2001 Jun;2(2):51-7. doi: 10.1034/j.1399-5448.2001.002002051.x.

  PMID: 15016198 RESULT

• Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase. Diabetes Care. 2011 Nov;34(11):2403-5. doi: 10.2337/dc11-1248. Epub 2011 Sep 20.

  PMID: 21933908 RESULT

• Forlenza GP, Li Z, Buckingham BA, Pinsker JE, Cengiz E, Wadwa RP, Ekhlaspour L, Church MM, Weinzimer SA, Jost E, Marcal T, Andre C, Carria L, Swanson V, Lum JW, Kollman C, Woodall W, Beck RW. Predictive Low-Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children With Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018 Oct;41(10):2155-2161. doi: 10.2337/dc18-0771. Epub 2018 Aug 8.

  PMID: 30089663 RESULT

• Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.

  PMID: 27629148 RESULT

• Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.

  PMID: 25078901 RESULT

• Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.

  PMID: 28134564 RESULT

• Salehi P, Roberts AJ, Kim GJ. Efficacy and Safety of Real-Life Usage of MiniMed 670G Automode in Children with Type 1 Diabetes Less than 7 Years Old. Diabetes Technol Ther. 2019 Aug;21(8):448-451. doi: 10.1089/dia.2019.0123. Epub 2019 Jun 5.

  PMID: 31166801 RESULT

• Lepore G, Scaranna C, Corsi A, Dodesini AR, Trevisan R. Switching from Suspend-Before-Low Insulin Pump Technology to a Hybrid Closed-Loop System Improves Glucose Control and Reduces Glucose Variability: A Retrospective Observational Case-Control Study. Diabetes Technol Ther. 2020 Apr;22(4):321-325. doi: 10.1089/dia.2019.0302. Epub 2020 Feb 11.

  PMID: 31617752 RESULT

• Steineck I, Cederholm J, Eliasson B, Rawshani A, Eeg-Olofsson K, Svensson AM, Zethelius B, Avdic T, Landin-Olsson M, Jendle J, Gudbjornsdottir S; Swedish National Diabetes Register. Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18,168 people with type 1 diabetes: observational study. BMJ. 2015 Jun 22;350:h3234. doi: 10.1136/bmj.h3234.

  PMID: 26100640 RESULT

• Rosenlund S, Hansen TW, Rossing P, Andersen S. Effect of Sensor-Augmented Pump Treatment Versus Multiple Daily Injections on Albuminuria: A 1-Year Randomized Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4181-8. doi: 10.1210/jc.2015-2839. Epub 2015 Sep 21.

  PMID: 26390102 RESULT

• Rosenlund S, Hansen TW, Andersen S, Rossing P. Effect of 4 years subcutaneous insulin infusion treatment on albuminuria, kidney function and HbA1c compared with multiple daily injections: a longitudinal follow-up study. Diabet Med. 2015 Nov;32(11):1445-52. doi: 10.1111/dme.12950. Epub 2015 Oct 6.

  PMID: 26331364 RESULT

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Paolo Fiorina, MD, PhD

  ASST-FBF-Sacco, University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elio Ippolito, MS

CONTACT

0239042648; elio.ippolito@unimi.it

Antonio Rossi, MD

CONTACT

0239044027; rossi.antonio@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D, Full Professor

Model Details: Open label randomized controlled trial

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 28, 2022
• Study Start: February 23, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 23, 2024
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)