Clinical trial NCT05069727: Simple Initiation of Advanced Hybrid Closed Loop System
Official title: Evaluation of Two Levels of Health Care Interactions in Adolescents With Type 1 Diabetes on Advanced Hybrid Closed Loop System MiniMed 780G/ Zeus Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes type1
Keywords: Automated Insulin Delivery
Time in Range
Intervention
Lead sponsor: Sidra Medicine
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Detailed description: 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
* Group 2, Simplified Clinical Protocol, 17 participants Intervention Description
* Intervention in Group 2, Simplified protocol.
* Insulin Carb Ratio (ICR) by formula 360 / Total Daily Dose (TDD)

  * ICR 8-10 (TDD 40-60)
  * ICR 5-7 (TDD \>60)
* Target 100 mg/dl
* Active Insulin Time (AIT): 2 hours
* Meals: Thee sets of meal set of meals announcement carbs calculated by the following formula:

  * 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 \* Efficacy The efficacy shall be measured Time in Ranges (provided by CGM data), for Time in Range (70-180mg/dl), Time below Range(\<70mg/dl) and Time above Range (\>180 mg/dl) in the third month of the study.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age 12-18 years and above at the initiation of the system
3. Total daily insulin use of great than 8.0 units per day over a 1-week period
4. Willing and able (access to internet from home)
5. Clinically able to start the AHCL system

Exclusion Criteria:

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

Primary outcomes:
measure: Time in Range( 70-180 mg/dl)
timeFrame: Third month
Secondary outcomes:
measure: HbA1c
timeFrame: 3 months
measure: Average Sensor Glucose
timeFrame: 3 months
measure: Time Bellow Range (<70 mg/dl, <54 mg/dl)
timeFrame: 3 months
measure: Time Above Range (>180 mg/dl)
timeFrame: 3 months
measure: Diabetic Ketoacidosis
timeFrame: 3 months
measure: Severe Hypoglycemia
timeFrame: 3 months
Other outcomes:
measure: Sensor wear
timeFrame: 3 months
measure: Auto Mode - SmartGuard
timeFrame: 3 months
measure: Total Daily Insulin
timeFrame: 3 months
Locations:
city: Doha
country: Qatar
facility: Sidra Medicine
state: Qa
Study officials:
affiliation: Sidra Medicine
name: Goran Petrovski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.