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Completed

NCT Number: NCT05069727

Simple Initiation of Advanced Hybrid Closed Loop System

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.

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Key information

Conditions

Diabetes type1

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidra Medicine

Doha, Qa, 26999, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Time in Range( 70-180 mg/dl)

    Time frame: Third month

    Group change in the third month of AHCL use

Secondary outcomes

  1. HbA1c

    Time frame: 3 months

    Change between groups

  2. Average Sensor Glucose

    Time frame: 3 months

    Change between groups

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

    Time frame: 3 months

    Change between groups

  4. Time Above Range (>180 mg/dl)

    Time frame: 3 months

    Change between groups

  5. Diabetic Ketoacidosis

    Time frame: 3 months

    Number of events in each group

  6. Severe Hypoglycemia

    Time frame: 3 months

    Number of events in each group

Other outcomes

  1. Sensor wear

    Time frame: 3 months

    % of sensor wear, change between each groups

  2. Auto Mode - SmartGuard

    Time frame: 3 months

    % of Automode-SmartGuard, change between groups

  3. Total Daily Insulin

    Time frame: 3 months

    % of Automode, Change between each groups

Sponsors and collaborators

Lead sponsor

Sidra Medicine

Other

Registry information

Official study 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

Acronym: 780GGS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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