Simple Initiation of Advanced Hybrid Closed Loop System

Diabetes type1 Clinical Trial

— 780GGS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069727
• Other study ID #: 600121
• Status: Completed
• Phase: N/A
• Start date: November 21, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2023
• Source: Sidra Medical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

Procedure:
• Regular Protocol with advanced carbohydrate counting
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).
• Simplified Protocol with fixed carbohydrate content
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.

Locations

Country	Name	City	State
Qatar	Sidra Medicine	Doha	Qa

Sponsors (1)

Lead Sponsor	Collaborator
Sidra Medical and Research Center

Country where clinical trial is conducted

Qatar, 

References & Publications (6)

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 Te — View 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 Stu — View 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 Clo — View 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 T — View 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. do — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensor wear	% of sensor wear, change between each groups	3 months
Other	Auto Mode - SmartGuard	% of Automode-SmartGuard, change between groups	3 months
Other	Total Daily Insulin	% of Automode, Change between each groups	3 months
Primary	Time in Range( 70-180 mg/dl)	Group change in the third month of AHCL use	Third month
Secondary	HbA1c	Change between groups	3 months
Secondary	Average Sensor Glucose	Change between groups	3 months
Secondary	Time Bellow Range (<70 mg/dl, <54 mg/dl)	Change between groups	3 months
Secondary	Time Above Range (>180 mg/dl)	Change between groups	3 months
Secondary	Diabetic Ketoacidosis	Number of events in each group	3 months
Secondary	Severe Hypoglycemia	Number of events in each group	3 months