Simple Initiation of Advanced Hybrid Closed Loop System

NCT05069727 | Completed

• 1 other identifier: 600121
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Aim. The new and advanced hybrid closed loop (AHCL) system MiniMed 780G automatically adjusts basal insulin delivery in addition to automated bolus corrections, based on continuous glucose monitoring (CGM) readings, to offer protection against both hyperglycemia and hypoglycemia. The objective of this study is to evaluate whether a simplified approach for patients' follow up using preset of pump settings and a simplified meal announcement, followed by minimal interaction can achieve similar glycemic control of AHCL system MiniMed 780G with Guardian Sensor 4 than a regular protocol that is currently used in adolescents with Type 1 Diabetes (T1D). Methods. This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. A total of 34 individuals (age 12-18 years) will be enrolled to reach 30 individuals who will complete the 3 months study. Participants will be randomized in two groups: Group 1, Regular Clinical Protocol, 17 participants and Group 2, Simplified Clinical Protocol, 17 participants. All patients will be recruited during the regular clinic visits to the outpatient Endocrine Clinics at Sidra Medicine in Doha. Patients will be chosen on a first-come first-served basis. Inclusion criteria: Clinical diagnosis of type 1 diabetes, , Age 12-18 years, Basal Bolus therapy \>8.0 units per day. Exclusion criteria: Diabetic Ketoacidosis (DKA) in the 6 months prior to screening visit. The initiation protocol consists of four stages: HCL system compatibility assessment, HCL system training, Manual Mode Start and Auto Mode start. Patients will have 7 visits in a period of 3 months after initiation of insulin pump therapy. Pump initiation: Group 1, Finetune ICR, Target 100 or 110 mg/dl and AIT: 2-3 hour and Group 2, Carb Ratio by formula 360 / TDD, ICR 8-10 (TDD 40-60), ICR 5-7 (TDD \>60), Target 100 mg/dl, AIT: 2 hours with fixed meals Results. No group difference in Time in Range (TIR) (70-180mg/dl) \> 70% and HbA1c \< 7.5% in a period of 3 months after initiation of AHCL. Conclusion. Conclusions will be drawn on completion of the study and evaluation of the results.

Conditions

Diabetes type1

Keywords

Automated Insulin Delivery; Time in Range; Intervention

Outcome Measures

Primary Outcomes (1)

• Time in Range( 70-180 mg/dl)

  Group change in the third month of AHCL use

  Third month

Secondary Outcomes (6)

• HbA1c

  3 months

• Average Sensor Glucose

  3 months

• Time Bellow Range (<70 mg/dl, <54 mg/dl)

  3 months

• Time Above Range (>180 mg/dl)

  3 months

• Diabetic Ketoacidosis

  3 months

Other Outcomes (3)

• Sensor wear

  3 months

• Auto Mode - SmartGuard

  3 months

• Total Daily Insulin

  3 months

Study Arms (2)

Group 1, Regular Protocol

ACTIVE COMPARATOR

Participants will bolus (insulin), based on carbohydrate content in each meal

Procedure: Regular Protocol with advanced carbohydrate counting

Group 2, Simplified protocol

EXPERIMENTAL

Participants will bolus (insulin), based on three sets of meal set of meals announcement

Procedure: Simplified Protocol with fixed carbohydrate content

Interventions

Regular Protocol with advanced carbohydrate counting PROCEDURE

* Review 3 Days CGM data in Manual Mode * Carb Ratio by formula 360 / TDD * Finetune ICR * Target 100 or 110 mg/dl * AIT: 2-3 hour * Insulin Bolus for meal (advanced carb counting) * The parameters will be set using clinical assessment and fine-tuned if needed on F-up visits. * Follow up visits will be scheduled Day 7, 14,28, 56 and 84 after enabling SmartGuard (AHCL use).

Group 1, Regular Protocol

Simplified Protocol with fixed carbohydrate content PROCEDURE

* Review 3 Days CGM data in Manual Mode * Carb Ratio by formula 360 / TDD ICR 8-10 (TDD 40-60) ICR 5-7 (TDD \>60) * Target 100 mg/dl * AIT: 2 hours * Insulin Bolus for meal (Thee sets of meal set of meals announcement carbs will be provided) Regular meal: Total Carbs per Day x 0.6 / 3 Large meal: Total Carbs per Day x 0.6 / 3 x 1.5 Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5 * Total carbs per day will be calculated as average on 7-days Food Logbook diary, provided by participant, one week before AHCL initiation. * The parameters will be fixed and fine-tuned only in case of hypoglycemia on F-up visits.

Group 2, Simplified protocol

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of type 1 diabetes \>0.5 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.
• Age 12-18 years and above at the initiation of the system
• 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)
• Clinically able to start the AHCL system

You may not qualify if:

• Pregnancy
• Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.
• Currently in other Clinical Trial

Sponsors & Collaborators

• Sidra Medicine: lead

Study Sites (1)

Sidra Medicine

Doha, Qa, 26999, Qatar

Location

Related Publications (7)

• Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. From Multiple Daily Injections to Hybrid Closed-Loop System in Ten Days, Utilizing a Structured Initiation Protocol. J Diabetes Sci Technol. 2020 May;14(3):689-690. doi: 10.1177/1932296819895509. Epub 2019 Dec 26. No abstract available.

  PMID: 31876178 BACKGROUND

• Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.

  PMID: 33453783 RESULT

• Beato-Vibora PI, Gallego-Gamero F, Ambrojo-Lopez A, Gil-Poch E, Martin-Romo I, Arroyo-Diez FJ. Rapid Improvement in Time in Range After the Implementation of an Advanced Hybrid Closed-Loop System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Sep;23(9):609-615. doi: 10.1089/dia.2021.0037. Epub 2021 Apr 20.

  PMID: 33784187 RESULT

• Lee MH, Vogrin S, Paldus B, Jones HM, Obeyesekere V, Sims C, Wyatt SA, Ward GM, McAuley SA, MacIsaac RJ, Krishnamurthy B, Sundararajan V, Jenkins AJ, O'Neal DN. Glucose Control in Adults with Type 1 Diabetes Using a Medtronic Prototype Enhanced-Hybrid Closed-Loop System: A Feasibility Study. Diabetes Technol Ther. 2019 Sep;21(9):499-506. doi: 10.1089/dia.2019.0120. Epub 2019 Jul 2.

  PMID: 31264889 RESULT

• 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 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

• Petrovski G, Campbell J, Pasha M, Hussain K, Khalifa A, Umer F, Almajaly D, Hamdar M, Heuvel TVD, Edd SN. Twelve-Month Follow-up from a Randomized Controlled Trial of Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents with Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed-Loop System. Diabetes Technol Ther. 2024 Mar;26(S3):76-83. doi: 10.1089/dia.2023.0429.

  PMID: 38377327 DERIVED

Study Officials

• Goran Petrovski, PhD

  Sidra Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Eligible subjects shall be randomly assigned to Group 1 or Group 2 in a 1:1 ratio using a computer-generated randomization scheme developed by the data manager.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof MD PhD

Model Details: This study is Randomized Clinical Trial, two arm, single-center, clinical investigation in subjects with type 1 diabetes on AHCL insulin pump in a period of 3 months. Participants will be randomized in two groups: * Group 1, Regular Clinical Protocol, 17 participants * Group 2, Simplified Clinical Protocol, 17 participants

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 6, 2021
• Study Start: November 21, 2021
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)