Simple Initiation of Advanced Hybrid Closed Loop System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Two Levels of Health Care Interactions in Adolescents With Type 1 Diabetes on Advanced Hybrid Closed Loop System MiniMed 780G/ Zeus Sensor

Conditions
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Diabetes type1

Intervention / Treatment
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* Procedure: Regular Protocol with advanced carbohydrate counting
* Procedure: Simplified Protocol with fixed carbohydrate content


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1, Regular Protocol<br>Participants will bolus (insulin), based on carbohydrate content in each meal | Procedure: Regular Protocol with advanced carbohydrate counting<br>* 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).<br>|
| Experimental: Group 2, Simplified protocol<br>Participants will bolus (insulin), based on three sets of meal set of meals announcement | Procedure: Simplified Protocol with fixed carbohydrate content<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range( 70-180 mg/dl) | Group change in the third month of AHCL use | Third month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change between groups | 3 months | 
| Average Sensor Glucose | Change between groups | 3 months | 
| Time Bellow Range (<70 mg/dl, <54 mg/dl) | Change between groups | 3 months | 
| Time Above Range (>180 mg/dl) | Change between groups | 3 months | 
| Diabetic Ketoacidosis | Number of events in each group | 3 months | 
| Severe Hypoglycemia | Number of events in each group | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated Insulin Delivery, Time in Range, Intervention