Simple Initiation of Advanced Hybrid Closed Loop System
Condition: Diabetes type1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Intervention name(s): Regular Protocol with advanced carbohydrate counting; Simplified Protocol with fixed carbohydrate content
Intervention type(s): Procedure; Procedure
Intervention description(s): 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).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Automated Insulin Delivery; Time in Range; Intervention