Simple Meal Management Using Automated Insulin Delivery System

NCT06130215 | Recruiting DMC

• 1 other identifier: 2035754
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Carbohydrate counting is an essential component of diabetes management in both adults and children, and together with an intensive insulin plan and increased blood glucose monitoring was associated with lower HbA1c. Carbohydrate counting is perceived as one of the most burdensome tasks in T1D and is frequently done inconsistently and with poor accuracy A recent analysis confirms that MiniMed™ Advaced Hybrid closed loop (AHCL) system is designed for optimal performance with meal announcement. Nonetheless, when meals containing \< 80 grams of carbohydrates are consumed with announcement of meals at will, there is a slight reduction in the number of daily boluses with no decline in glycemic control, yet markedly less diabetes related distress and improved treatment satisfaction TIR of 78.1% in unannounced meals compared with 78.8% with announced meals .

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Meal Management; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (4)

• Hba1c

  Change in %

  3 months

• Time in Range (70-180mg/dl)

  Change in %

  3 months

• Time below Range (<54mg/dl and <70mg/dl)

  Change in %

  3 months

• Time above Range (>180mg/dl and >250mg/dl)

  Change in %

  3 months

Secondary Outcomes (4)

• Total Daily insulin dose

  3 months

• Autocorrection insulin dose

  3 months

• Severe hypoglycemia

  3 months

• Diabetic Ketoacidosis

  3 months

Other Outcomes (1)

• Ped Quality of Life Survey

  3 months

Study Arms (2)

Fix meal annoucement with three presets of carbohydrates

EXPERIMENTAL

simple meal management

Other: Simple meal management

Flex meal annoucement with precise carbohydrate counting

ACTIVE COMPARATOR

precise meal management

Other: Precise meal management

Interventions

Simple meal management OTHER

* 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

Fix meal annoucement with three presets of carbohydrates

Precise meal management OTHER

precise carbohydrate counting for each meal

Flex meal annoucement with precise carbohydrate counting

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of type 1 diabetes \>1 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 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) to download information into the Medtronic CareLink software
• Clinically able to start the AHCL system

You may not qualify if:

• Pregnancy
• Untreated diabetes retinopathy, or other causes that in the investigator's opinion , precludes the individual from participating in the trial.

Sponsors & Collaborators

• Sidra Medicine: lead

Study Sites (1)

Sidra Medicine

Doha, Qa, 1000, Qatar

RECRUITING

Related Publications (9)

• Bosi E, Choudhary P, de Valk HW, Lablanche S, Castaneda J, de Portu S, Da Silva J, Re R, Vorrink-de Groot L, Shin J, Kaufman FR, Cohen O; SMILE Study Group. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):462-472. doi: 10.1016/S2213-8587(19)30150-0. Epub 2019 Apr 29.

  PMID: 31047902 BACKGROUND

• Nathanson D, Svensson AM, Miftaraj M, Franzen S, Bolinder J, Eeg-Olofsson K. Effect of flash glucose monitoring in adults with type 1 diabetes: a nationwide, longitudinal observational study of 14,372 flash users compared with 7691 glucose sensor naive controls. Diabetologia. 2021 Jul;64(7):1595-1603. doi: 10.1007/s00125-021-05437-z. Epub 2021 Mar 27.

  PMID: 33774713 BACKGROUND

• Tornese G, Carletti C, Giangreco M, Nistico D, Faleschini E, Barbi E. Carbohydrate Tolerance Threshold for Unannounced Snacks in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System. Diabetes Care. 2022 Jun 2;45(6):1486-1488. doi: 10.2337/dc21-2643.

  PMID: 35522033 BACKGROUND

• Arrieta A, Battelino T, Scaramuzza AE, Da Silva J, Castaneda J, Cordero TL, Shin J, Cohen O. Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real-world users. Diabetes Obes Metab. 2022 Jul;24(7):1370-1379. doi: 10.1111/dom.14714. Epub 2022 May 12.

  PMID: 35403792 BACKGROUND

• Silva JD, Lepore G, Battelino T, Arrieta A, Castaneda J, Grossman B, Shin J, Cohen O. Real-World Performance of the MiniMed 780G System: First Report of Outcomes from 4120 Users. Diabetes Technol Ther. 2022 Feb;24(2):113-119. doi: 10.1089/dia.2021.0203.

  PMID: 34524003 BACKGROUND

• Bell KJ, Barclay AW, Petocz P, Colagiuri S, Brand-Miller JC. Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2014 Feb;2(2):133-40. doi: 10.1016/S2213-8587(13)70144-X. Epub 2013 Oct 25.

  PMID: 24622717 BACKGROUND

• Mehta SN, Quinn N, Volkening LK, Laffel LM. Impact of carbohydrate counting on glycemic control in children with type 1 diabetes. Diabetes Care. 2009 Jun;32(6):1014-6. doi: 10.2337/dc08-2068. Epub 2009 Feb 24.

  PMID: 19244089 BACKGROUND

• 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. doi: 10.1007/s00592-019-01472-w. Epub 2020 Jan 17.

  PMID: 31953687 BACKGROUND

• Petrovski G, Campbell J, Pasha M, Day E, Hussain K, Khalifa A, van den Heuvel T. Simplified Meal Announcement Versus Precise Carbohydrate Counting in Adolescents With Type 1 Diabetes Using the MiniMed 780G Advanced Hybrid Closed Loop System: A Randomized Controlled Trial Comparing Glucose Control. Diabetes Care. 2023 Mar 1;46(3):544-550. doi: 10.2337/dc22-1692.

  PMID: 36598841 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Goran Petrovski, PhD

  Sidra Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Goran Petrovski, PhD

CONTACT

0097440035588; goran.endo@gmail.com

Judith Campbell, NP

CONTACT

0097440035588; jcampbell@sidra.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Physcian, Prof, MD, PhD

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: November 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)