Studies Show Promising Results For Individuals With Type 2 Diabetes And Young Children With Type 1 Diabetes On Minimedtm 780G System

(MENAFN- PR Newswire) Separately, results from the Medtronic LENNY trial were published ⁱ in The Lancet Diabetes & Endocrinology . This multi-center, randomized controlled, crossover trial evaluated the MiniMedTM 780G system in young children (ages 2-6 years) with type 1 diabetes in a home setting. Results showed those using the MiniMedTM 780G system with SmartGuardTM achieved a 0.6% lower HbA1C and 9.9% higher Time in Range when compared to a baseline therapy of manual mode or hybrid closed loop without autocorrections. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia when the system was used in auto mode (with SmartGuardTM) compared to manual mode.

Benefits of automated insulin delivery (AID) systems for type 2 diabetes
While the standard of care for type 2 diabetes often includes lifestyle modifications and oral medications, many individuals require intensive insulin therapy to achieve optimal glucose management.

The ADA's 2025 Standards of Careⁱⁱ now endorse the use of AID systems for adults with insulin-intensive type 2 diabetes, recognizing their potential to significantly improve clinical outcomes - an important validation of the growing role of diabetes technology in transforming chronic disease management.

A 31-site single arm trial evaluated the MiniMedTM 780G system paired with the Simplera SyncTM sensor in a cohort of 236 individuals with type 2 diabetes. Results were promising across all clinical outcome metrics including Time in Range (TIR), Time in Tight Range (TITR), Time Above Range (TAR) compared to the run-in period where hybrid closed loop (auto basal only) or open-loop delivery was used. Time below range (TBR) remained stable.

"As the industry moves toward broader indications of automated insulin delivery systems, we see tremendous potential to improve outcomes and quality of life for millions of people managing type 2 diabetes with insulin," said Dr. Robert Vigersky, Chief Medical Officer, Medtronic Diabetes. "Our teams are committed to advancing smart, connected technologies that reduce the daily burden of care and bring precision to insulin therapy like never before."

	Baselinea	Studyb	Change (Study - Baseline)	P
Participants, N	236	232	--	--
Time in AHCL, %	--	92.4 ± 15.7	--	--
A1C, %	7.7 ± 0.9	6.9 ± 0.7c	-0.8 ± 0.9c	<0.0001
Mean SG, mg/dL	152.9 ± 21.2	140.7 ± 13.3	-12.3 ± 19.5	<0.0001
CV of SG, %	25.1 ± 4.8	25.6 ± 4.8	0.4 ± 3.3	0.073h
TBR <54 mg/dL, %	0.0 ± 0.1	0.0 ± 0.1	-0.0 ± 0.1	0.277
TBR <70 mg/dL, %	0.3 ± 0.5	0.3 ± 0.4	0.0 ± 0.5	0.056
TITR 70-140 mg/dL, %	45.3 ± 19.7	58.1 ± 13.6	13.0 ± 18.8	<0.0001h
TIR 70-180 mg/dL, %	76.4 ± 15.9	84.9 ± 9.7	8.6 ± 14.4	<0.0001
TAR >180 mg/dL, %	23.4 ± 15.9	14.8 ± 9.7	-8.6 ± 14.5	<0.0001
TAR >250 mg/dL, %	3.5 ± 5.2	1.7 ± 2.5	-1.8 ± 4.6	<0.0001
TDD, U	61.0 ± 36.1	76.1 ± 44.1	14.5 ± 25.1	<0.0001
Basal and bolus insulin
Total basal, U	34.6 ± 21.3	39.8 ± 23.9	4.9 ± 16.8	<0.0001
Total bolus, U	26.5 ± 20.7	36.3 ± 23.8	9.6 ± 15.1	<0.0001
Auto bolus, U	--	13.7 ± 11.1	--	--
Auto bolus, %TDD	--	17.2 ± 8.5	--	--
Auto bolus, %Total bolus	--	39.3 ± 21.8d	--	--
System-initiated insulin
Automated insulin, U	0.5 ± 3.4	51.2 ± 33.4	50.7 ± 33.7	<0.0001
Automated insulin, %TDD	0.9 ± 5.8	65.9 ± 17.3	65.0 ± 17.8	<0.0001
Daily carbohydrate, g	119.1± 87.4	127.7 ± 88.9	7.7 ± 84.6	0.571
ICR	7.6 ± 4.0d	6.9 ± 3.8e	-0.6 ± 1.5f	<0.0001
Weight, kg	98.0 ± 22.8g	98.4 ± 23.0c	0.7 ± 4.7c	0.006
BMI, kg/m2	34.0 ± 7.3g	34.2 ± 7.4c	0.2 ± 1.7c	0.006

Table 1. Glycemic outcomes, insulin delivery and weight during MiniMedTM 780G system use with the Simplera SyncTM sensor in adults with type 2 diabetes

Data are shown as mean±SD.
^aOpen loop (with or without predictive low glucose management) or HCL. AHCL was inadvertently (temporarily) enabled on 13 systems.
^bData represent the last 6 weeks of the study period with glucose target set at the investigator's discretion.
^cN=229, ^dN=231, ^eN=228. ^fN=224.^gN=235.
^hPaired two-sided t-test; otherwise, Wilcoxon signed-rank test.
BMI, Body mass index; CV, Coefficient of variation; ICR, Insulin-to-carb ratio; SG, Sensor glucose; TAR, Time above range; TBR, Time below range; TIR, Time in range; TITR, Time in tight range; TDD, Total daily dose; U, Units.
The MiniMedTM 780G system has not been approved for use in type 2 diabetes by U.S. FDA or other regulatory bodies.

Impact on families of young children with diabetes
Managing type 1 diabetes in young children and toddlers can be challenging for families. Data from the Lenny trial, published in The Lancet Diabetes & Endocrinology, highlighted how young children aged 2-6 years old achieved improved glycemic outcomes using the MiniMedTM 780G system.

"To preserve brain development and minimize long-term diabetes complications, it is essential that blood glucose concentrations are maintained close to healthy ranges from disease onset in early life," said Prof. Tadej Battelino, MD, Head of Department of Pediatric and Adolescent Endocrinology, UMC Ljubljana, Slovenia. "We are hopeful that if the data continues to be strong, the MiniMedTM 780G system can help make this possible."

After a run-in phase, subjects using the MiniMedTM 780G system with the GuardianTM 4 sensor were randomized into two sequences, consisting of a 12-week auto mode period (advanced hybrid closed loop), a 2-week wash-out phase and 12-week manual mode period (with suspend before low feature activated), or vice-versa. In total, there were 98 subjects across 12 centers in 4 countries. Results showed significantly** better glycemic management in auto mode, as shown in Figure 1 and Table 2 below. With no severe hypoglycemic events, the study showed an acceptable safety profile. Participants in auto mode spent on average 145 minutes per day more in range than those in manual mode. This improvement was primarily driven by a reduction in hyperglycemia, which is a major contributor to long-term complications.

"We're hopeful that if the data continues to be strong, we will receive future indication expansion so the most vulnerable group, small children under 7 years, and their families can also benefit from this technology ", said Prof. Ohad Cohen, M.D., senior global medical affairs director, Medtronic Diabetes.

Table 2: Glycemic metrics during the run-in phase, the manual mode period, and the auto mode period.

	Run-in	Manual Mode	Auto Mode
HbA1c, %	7.53 ± 0.96	7.61 ± 0.91	7.00 ± 0.53
HbA1c, mmol/mol	58.8 ± 10.5	59.7 ± 9.9	53.0 ± 5.8
Mean glucose, mg/dl	169.6 ± 25.7	169.1 ± 23.1	150.2 ± 10.7
SD of SG, mg/dl	65.0 ± 14.7	65.4 ± 13.2	61.8 ±10.9
GMI, %	7.4 ± 0.6	7.4 ± 0.5	6.9 ± 0.3

Table 2: Glycemic metrics during the run-in phase, the manual mode period, and the auto mode period. During manual mode, the suspend before low (SBL) feature was activated. During run-in, the system was also used in manual mode with SBL activated. Data are shown as mean ± SD.

The emotional toll of diabetes for parents and caregivers
Managing type 1 diabetes in toddlers and young children can be emotionally stressful for parents and caregivers due to the need for constant blood sugar monitoring, dietary management, insulin administration and disrupted routines and sleep. A survey of caregivers in the LENNY trial indicated that when their child used auto mode, they experienced relatively low fear of hypoglycemia and high sleep quality.

	Run-in	Manual Mode	Auto Mode
Parent hypoglycemia fear survey (HFS-P)	44.75 ± 14.9	42.9 ± 13.3	40.9 ± 13.2
Pittsburgh Sleep Quality Index (PSQI)	7.1 ± 3.8	7.1 ± 4.0	5.9 ± 3.2

Table 3: Parent hypoglycemia fear survey and Pittsburgh Sleep Quality Index during the run-in phase, the manual mode period and the auto mode period. During manual mode, the suspend before low (SBL) feature was activated. During run-in, the system was also used in manual mode with SBL activated.

Medtronic will seek future expansion of indications for a broader population
The MiniMedTM 780G system currently is not indicated for use in in type 2 diabetes or young children under 7 years old by the U.S. Food and Drug Administration (FDA) or other regulatory bodies. Medtronic intends to work with global regulators towards expanding access to its diabetes technology for insulin-intensive type 2 diabetes, as well as a lower age indication for those with type 1 diabetes.

About the Diabetes Business at Medtronic
Medtronic Diabetes is on a mission to make diabetes more predictable, so everyone can embrace life to the fullest with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

*MiniMedTM 780G system is for type 1 ages 7 years and over. Prescription required. WARNING: Do not use SmartGuardTM feature for people who require less than 8 units or more than 250 units of insulin/day. See the User Guide for a detailed list of information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For details, see
** Significance was shown via confidence intervals
§ Refers to SmartGuardTM feature. Individual results may vary.
† Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off.

ⁱ Battelino et al. Efficacy and safety of automated insulin delivery in children aged 2–6 years (LENNY): an open-label, multicentre, randomised, crossover trial; Lancet Diabetes Endocrinol 2025
ⁱⁱ American Diabetes Association Professional Practice Committee: Diabetes Care 2025;48(Supplement_1):S146–S166

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