Evaluation on Glycemic Control Using Two Different Meal Announcement Plans in Adolescents With Type 1 Diabetes on Minimed 780G Hybrid Closed Loop System

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Qatar
Sidra Medicine
RECRUITING
Doha
Contact Information
Primary
Goran Petrovski, PhD
goran.endo@gmail.com
0097440035588
Backup
Judith Campbell, NP
jcampbell@sidra.org
0097440035588
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 34
Treatments
Experimental: Fix meal annoucement with three presets of carbohydrates
simple meal management
Active_comparator: Flex meal annoucement with precise carbohydrate counting
precise meal management
Related Therapeutic Areas
Sponsors
Leads: Sidra Medicine

This content was sourced from clinicaltrials.gov