Simple Initiation of Advanced Hybrid Closed Loop System (780GGS)

April 11, 2023 updated by: Goran Petrovski, Sidra Medical and Research Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
    • Qa
      • Doha, Qa, Qatar, 26999
        • Sidra Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1, Regular Protocol
Participants will bolus (insulin), based on carbohydrate content in each meal
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).
Experimental: Group 2, Simplified protocol
Participants will bolus (insulin), based on three sets of meal set of meals announcement
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensor wear
Time Frame: 3 months
% of sensor wear, change between each groups
3 months
Auto Mode - SmartGuard
Time Frame: 3 months
% of Automode-SmartGuard, change between groups
3 months
Total Daily Insulin
Time Frame: 3 months
% of Automode, Change between each groups
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidra Medical and Research Center

Investigators

  • Principal Investigator: Goran Petrovski, PhD, Sidra Medical and Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

September 26, 2021

First Posted (Actual)

October 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 600121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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