Type 1 Diabetes Clinical Trial
— SMMAIDOfficial title:
Evaluation on Glycemic Control Using Two Different Meal Announcement Plans in Adolescents With Type 1 Diabetes on Minimed 780G Hybrid Closed Loop System
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 MiniMedâ„¢ 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 .
Status | Recruiting |
Enrollment | 34 |
Est. completion date | July 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Age 12 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) to download information into the Medtronic CareLink software 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. |
Country | Name | City | State |
---|---|---|---|
Qatar | Sidra Medicine | Doha | Qa |
Lead Sponsor | Collaborator |
---|---|
Sidra Medicine |
Qatar,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ped Quality of Life Survey | Total score | 3 months | |
Primary | Hba1c | Change in % | 3 months | |
Primary | Time in Range (70-180mg/dl) | Change in % | 3 months | |
Primary | Time below Range (<54mg/dl and <70mg/dl) | Change in % | 3 months | |
Primary | Time above Range (>180mg/dl and >250mg/dl) | Change in % | 3 months | |
Secondary | Total Daily insulin dose | Change in units per day | 3 months | |
Secondary | Autocorrection insulin dose | Change in units per day | 3 months | |
Secondary | Severe hypoglycemia | number of events during the 3 months | 3 months | |
Secondary | Diabetic Ketoacidosis | number of events during the 3 months | 3 months |
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