Evidence map›Paper›PMID 34293955›Full record

Trial reportJournal of diabetes science and technology2023

Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-Over Trial.

Rodolfo J Galindo, Clementina Ramos, Saumeth Cardona, Priyathama Vellanki, Georgia M Davis, Omolade Oladejo, Bonnie Albury, Neil Dhruv, Limin Peng, Guillermo E Umpierrez

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07061301 (Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus and Incorporation Into a Comprehensive Diabetes Management System), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 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.

NCT07061301 narecruitingnot on this mapstarted 2024, after this paper: background citation

Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus and Incorporation Into a Comprehensive Diabetes Management System

TypeinterventionalSponsorInstituto de Investigacion Sanitaria La FeRan2024 to 2026Enrolled80ConditionsType 2 Diabetes Mellitus (T2DM), Continuous Glucose Monitoring, CGM, Transition to DischargeArmsUsual Care group, Technological group
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Observational
  5. Observational
  6. Observational
  7. Connected Insulin Pens and Pen Caps: Expanding Diabetes Technology Access and Adoption.Diabetes spectrum : a publication of the American Diabetes Association · 2025
    Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. STYLCONNECT Study: An Assessment of Automatic Data Collection Devices by People Living with Diabetes and Using an Insulin Pen.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  14. First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis.Clinical diabetes : a publication of the American Diabetes Association · 2023
    Article
  15. The emerging role of digital health in the management of asthma.Therapeutic advances in chronic disease · 2023
    Review
  16. Telehealth Technologies and Their Benefits to People With Diabetes.Diabetes spectrum : a publication of the American Diabetes Association · 2022
    Article
  17. Review
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Rodolfo J GalindoEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.ORCID 0000-0002-9295-3225
Clementina RamosEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.
Saumeth CardonaEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.ORCID 0000-0003-1295-1754
Priyathama VellankiEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.
Georgia M DavisEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.
Omolade OladejoEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.ORCID 0000-0002-6150-6705
Bonnie AlburyEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.
Neil Dhruv
Limin PengEmory University Rollins School of Public Health, Atlanta, GA, USA.
Guillermo E UmpierrezEmory University School of Medicine, Division of Endocrinology and Diabetes, Grady Memorial Hospital, Atlanta, GA, USA.ORCID 0000-0002-3252-5026

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Translational Research Core - Engagement and Behavior ChangeP30DK111024 · NIDDK · EMORY UNIVERSITY · PI Mohammed Kumail Ali · 2016 to 2026
$13.4M
Emory University BIRCWH ProgramK12HD085850 · NICHD · EMORY UNIVERSITY · PI OFOTOKUN, IGHOVWERHA, STERK, CLAIRE E · 2015 to 2023
$4.4M
Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery PatientsK23GM128221 · NIGMS · EMORY UNIVERSITY · PI PASQUEL, FRANCISCO J · 2018 to 2022
$957k
Use of Continuous Glucose Monitoring (CGM) in End-Stage Renal Disease(ESRD) Patients with Type 2 DiabetesK23DK123384 · NIDDK · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI GALINDO, RODOLFO · 2020 to 2024
$934k
Perioperative Stress Hyperglycemia in General and Vascular Surgery PatientsK23DK122199 · NIDDK · EMORY UNIVERSITY · PI DAVIS, GEORGIA M · 2020 to 2024
$891k
NCATS NIH HHS UL1 TR002378NICHD NIH HHS K12 HD085850NIDDK NIH HHS K23 DK122199NIDDK NIH HHS K23 DK123384NIDDK NIH HHS P30 DK111024NIGMS NIH HHS K23 GM128221
6 · The paper itself

Abstract

backgroundWe studied a smart insulin pen cap that can be plugged to several brand of insulin pens, to track insulin administration via smart-phone Bluetooth technology, with alarm/reminder system aiming.

methodsThis pilot randomized, cross-over design study assessed the use of a smart insulin pen cap in improving adherence, glycemic control and patient satisfaction in insulin-treated patients with poorly controlled type 2 diabetes. Eighty patients on basal insulin ± oral agents with hemoglobin A1C (HbA1c) between 7.0% and 12.0% were randomized to a 12-week active phase receiving alarms/reminders and a 12-week control/masked phase without feedback. We assessed differences between groups on treatment adherence, insulin omission, and mistiming of insulin injections, HbA1c, treatment satisfaction (using Diabetes Treatment Satisfaction Questionnaire Status).

resultsCompared to the control/masked phase, the active phase resulted in lower mean daily blood glucose (147.0 ± 34 vs 157.6 ± 42 mg/dL,

conclusionsThe results of this pilot study indicates that this smart insulin pen cap was effective in improving glycemic control with overall good satisfaction in insulin treated patients with type 2 diabetes. Future studies are needed to confirm its potential for improving care in insulin treated patients with diabetes.

Indexed as

Diabetes Mellitus, Type 2Blood GlucoseCross-Over StudiesGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin, Regular, HumanPilot ProjectsBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinInsulin, Regular, Humanglycemic controlinsulin administrationSmart Insulin Pen Captreatment satisfactiontype 2 diabetes

Identifiers

PMID34293955
PMCPMC9846390

What OpenQuestion holds

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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 OpenQuestion graph.