Evidence map›Paper›PMID 39714936›Full record

Trial reportNEJM evidence2025

Automated Insulin Delivery in Older Adults with Type 1 Diabetes.

Yogish C Kudva, Robert J Henderson, Lauren G Kanapka, Ruth S Weinstock, Michael R Rickels, Richard E Pratley, Naomi Chaytor, Kamille Janess, Donna Desjardins, Vishwanath Pattan and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in NEJM evidence, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04016662 (A Randomized Cross-over Trial Evaluating Automated Insulin Delivery Technologies on Hypoglycemia and Quality of Life in Elderly Adults With Type 1 Diabetes), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04016662 phase4completednot on this map

A Randomized Cross-over Trial Evaluating Automated Insulin Delivery Technologies on Hypoglycemia and Quality of Life in Elderly Adults With Type 1 Diabetes

TypeinterventionalSponsorJaeb Center for Health ResearchRan2020 to 2024Enrolled82ConditionsType 1 Diabetes MellitusArmsTandem t:slim X2 with HCL or PLGS
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
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  6. Review
  7. Article
  8. Article
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  12. Clin-STAR Corner: Practice Changing Advances in Diabetes Care.Journal of the American Geriatrics Society · 2025
    Review
  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Yogish C KudvaDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Robert J HendersonJaeb Center for Health Research, Tampa, FL.
Lauren G KanapkaJaeb Center for Health Research, Tampa, FL.
Ruth S WeinstockDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, State University of New York Upstate Medical University, Syracuse.
Michael R RickelsDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Richard E PratleyAdventHealth Translational Research Institute, Orlando, FL.
Naomi ChaytorElson S. Floyd College of Medicine, Washington State University, Spokane.
Kamille JanessJaeb Center for Health Research, Tampa, FL.
Donna DesjardinsDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Vishwanath PattanEndocrinology at Elkhart Clinic, Mishawaka, IN.
Amy J PeleckisDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Anna CasuAdventHealth Translational Research Institute, Orlando, FL.
Shafaq Raza RizviDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Suzan BzdickDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, State University of New York Upstate Medical University, Syracuse.
Keri J WhitakerAdventHealth Translational Research Institute, Orlando, FL.
Jorge L Jo KamimotoDivision of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Kellee MillerT1D Exchange, St Petersburg, FL.
Craig KollmanJaeb Center for Health Research, Tampa, FL.
Roy W BeckJaeb Center for Health Research, Tampa, FL.

Funding

Institutional Clinical and Translational Science AwardUL1TR001878 · UNIVERSITY OF PENNSYLVANIA · 2025 to 2025
$10.2M
The Chronic Pancreatitis Clinical Research ConsortiumU01DK144420 · UNIVERSITY OF FLORIDA · 2025 to 2025
$436k
NCATS NIH HHS UL1 TR001878NIDDK NIH HHS R01 DK122603NIDDK NIH HHS U01 DK144420
6 · The paper itself

Abstract

backgroundOlder adults with type 1 diabetes are at risk for serious hypoglycemia. Automated insulin delivery can reduce risk but has not been sufficiently evaluated in this population.

methodsWe conducted a multicenter, randomized crossover trial in adults older than or equal to 65 years of age with type 1 diabetes. Participants completed three 12-week periods of using hybrid closed loop, predictive low-glucose suspend, and sensor-augmented pump insulin delivery in a randomized order. The primary outcome was the percentage of time with continuous glucose monitoring glucose values less than 70 mg/dl.

resultsEighty-two participants between 65 and 86 years of age were randomly assigned: 45% were female; the baseline mean (±SD) glycated hemoglobin level was 7.2±0.9%; and the baseline percentage of time with glucose values less than 70 mg/dl was 2.49±1.78%. In the sensor-augmented pump, hybrid closed-loop, and predictive low-glucose suspend periods, percentages of time with glucose less than 70 mg/dl were 2.57±1.54%, 1.58±0.95%, and 1.67±0.96%, respectively. Compared with the sensor-augmented pump results, the mean difference with the hybrid closed-loop system was -1.05 percentage points (95% confidence interval [CI], -1.48 to -0.73 percentage points; P<0.001) and with the predictive low-glucose suspend system it was -0.93 percentage points (95% CI, -1.27 to -0.66 percentage points; P<0.001). Comparing a hybrid closed-loop system with a sensor-augmented pump, time in the range 70 to 180 mg/dl changed by 8.9 percentage points (95% CI, 7.4 to 10.4 percentage points) and the glycated hemoglobin level changed by 0.2 percentage points (95% CI, -0.3 to -0.1 percentage points). Serious adverse events were uncommon. Severe hypoglycemia occurred in 4% or less of participants; there were two hospitalizations for diabetic ketoacidosis.

conclusionsIn older adults with type 1 diabetes, automated insulin delivery decreased hypoglycemia compared with sensor-augmented pump delivery. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number: NCT04016662.).

Indexed as

Blood GlucoseCross-Over StudiesDiabetes Mellitus, Type 1Hypoglycemic AgentsInsulinInsulin Infusion SystemsAgedAged, 80 and overBlood Glucose Self-MonitoringFemaleGlycated HemoglobinHumansHypoglycemiaMaleBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID39714936
PMCPMC11840810

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.