An 8-Day Initiation of Advanced Hybrid Closed Loop System In Children and Adolescents

NCT04509362 | Completed DMC

• 1 other identifier: 00009930
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

One of the available Hybrid closed loop system is MiniMed 670G (Medtronic Diabetes, Northridge, CA, USA), which is indicated for children above 7 years old, adolescents and adults with Type 1 Diabetes. Several studies have shown improved HbA1c, time in target range, and SG variability in children, adolescents and adults with Type 1 Diabetes, where participants were experienced with using CSII therapy, assuming that the success of HCL systems depend on prior use of pump therapy. A recent study, published by diabetes team from Sidra Medicine, Doha has showed that children and adolescents with Type 1 Diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol, achieving better outcomes than in previous studies, where participants had previous experience with diabetes related technology and longer initiation process. The AHCL system, Minimed 780G is CE-marked includes additional functionality aiming to provide further protections from highs. The user can choose the algorithm to target a glucose level of 100 or 120 mg/dL. Like for the MiniMed 670G HCL system, users can also choose the algorithm to temporarily target a glucose value of 150 mg/dL. In addition, the AHCL system has the ability to administer correction bolus automatically, targeting 120 mg/dL. The AHCL algorithm was evaluated with a model-based algorithm design platform incorporating a virtual patient simulator, where additional changes were made (lower target ranges and automated correction boluses ( )). A recent study including 12 patients with type 1 diabetes on AHCL system, has shown no episodes of hypoglycemia or diabetic ketoacidosis, while maintaining 99% time spent in closed loop and high time in ra1\]\\nge ( ). AHCL decreased Auto Mode exits and alerts, and improves glycaemia without compromising safety, despite multiple food and exercise challenges ( ). Sidra Medicine is the only center for childhood diabetes in Qatar. Around 80% of type 1 diabetes patients are using a device (insulin pump/glucose sensor) and around 45% are using sensor-augmented pump (SAP)/HCL systems.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Advanced Hybrid Closed Loop System; Minimed 780G; Initiation Protocol

Outcome Measures

Primary Outcomes (2)

• TIR (70-180 mg/dl)

  Change from baseline to the first 3 months

  3 months

• TIR (70-180 mg/dl

  Change from baseline to the 12 months

  12 months

Secondary Outcomes (10)

• HbA1c change

  3 months

• HbA1c change

  12 months

• Sensor glucose wear

  3 months

• Sensor glucose wear

  12 months

• Auto Mode Usage

  3 months

Interventions

Advanced Hybrid Closed Loop System DEVICE

Evaluation of the use of an 8-day structured protocol to initiate patients from MDI to the AHCL system, in achieving safe glycemic control

Also known as: Minimed 780G

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Type 1 Diabetes, on multiple daily injections, using self-monitoring of blood glucose or continuous glucose monitoring, no prior pump experience.

You may qualify if:

• Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
• HbA1c \< 12.5%
• Age 7-17 years at the initiation of the system
• Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
• Willing and able (access to internet from home) to download information into the Medtronic CareLink software
• Clinically able to start the AHCL system
• History of 3 clinic visits in the last year

You may not qualify if:

• DKA in the 6 months prior to screening visit
• Pregnancy
• Untreated diabetes retinopathy, or other causes that ,in the investigator's opinion, precludes the individual from participating in the trial.

Sponsors & Collaborators

• Sidra Medicine: lead

Study Sites (1)

Sidra Medicine

Doha, Qa, 26999, Qatar

Location

Related Publications (10)

• 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 BACKGROUND

• Grosman B, Wu D, Miller D, Lintereur L, Roy A, Parikh N, Kaufman FR. Sensor-Augmented Pump-Based Customized Mathematical Model for Type 1 Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):207-221. doi: 10.1089/dia.2017.0333.

  PMID: 29565722 BACKGROUND

• Paldus B, Lee MH, Jones HM, McAuley SA, Horsburgh JC, Roem KL, Ward GM, MacIsaac RJ, Cohen N, Colman PG, Jenkins AJ, O'Neal DN. Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. Diabetes Technol Ther. 2019 Jan;21(1):56-58. doi: 10.1089/dia.2018.0279.

  PMID: 30620641 BACKGROUND

• Thabit H, Hovorka R. Coming of age: the artificial pancreas for type 1 diabetes. Diabetologia. 2016 Sep;59(9):1795-805. doi: 10.1007/s00125-016-4022-4. Epub 2016 Jun 30.

  PMID: 27364997 RESULT

• Biester T, Nir J, Remus K, Farfel A, Muller I, Biester S, Atlas E, Dovc K, Bratina N, Kordonouri O, Battelino T, Philip M, Danne T, Nimri R. DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home. Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.

  PMID: 30478937 RESULT

• U.S. Food and Drug Administration (2019) FDA approves first automated insulin delivery device for type 1 diabetes. Available from www.fda.gov/news-events/press-announcements/fda-approves-first-automated-insulin-delivery-device-type-1-diabetes. Accessed 21 March 2019

  RESULT

• Weaver KW, Hirsch IB. The Hybrid Closed-Loop System: Evolution and Practical Applications. Diabetes Technol Ther. 2018 Jun;20(S2):S216-S223. doi: 10.1089/dia.2018.0091. Epub 2018 Jun 6.

  PMID: 29873517 RESULT

• Trevitt S, Simpson S, Wood A. Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes: What Systems Are in Development? J Diabetes Sci Technol. 2016 May 3;10(3):714-23. doi: 10.1177/1932296815617968. Print 2016 May.

  PMID: 26589628 RESULT

• Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, Shulman DI, Bailey TS, Bode BW, Wood MA, Buckingham BA, Kaiserman KB, Shin J, Huang S, Lee SW, Kaufman FR. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26.

  PMID: 30585770 RESULT

• Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. 10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol. 2020 Jun;57(6):681-687. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.

  PMID: 31953687 RESULT

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: August 12, 2020
• Study Start: October 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: September 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

QA (1)