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ArticleTrials2020

Lifestyle changes and glycemic control in type 1 diabetes mellitus: a trial protocol with factorial design approach.

Sobiya Sawani, Amna Rehana Siddiqui, Syed Iqbal Azam, Khadija Humayun, Asma Ahmed, Aysha Habib, Sabahat Naz, Mayera Tufail, Romaina Iqbal

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03864991 (Lifestyle Changes and Glycemic Control in Type 1 Diabetes Mellitus), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
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.

NCT03864991 naunknown statusnot on this map

Lifestyle Changes and Glycemic Control in Type 1 Diabetes Mellitus: A Factorial Design Approach

TypeinterventionalSponsorAga Khan UniversityRan2018 to 2020Enrolled120ConditionsType1 Diabetes Mellitus, Life Style, Behavioral Changes, Self-ManagementArmse-device for step count (fit-bit), e-messages for log book, e-messages for log book & fit-bit
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
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

9 authors at 1 institution in 1 country.

Sobiya SawaniDepartment of Community Health Sciences, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan. sobiya.sawani@aku.edu.
Amna Rehana SiddiquiDepartment of Community Health Sciences, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Syed Iqbal AzamDepartment of Community Health Sciences, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Khadija HumayunDepartment of Pediatrics & Child Health, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Asma AhmedDepartment of Medicine, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Aysha HabibDepartment of Pathology & Laboratory Medicine, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Sabahat NazDepartment of Community Health Sciences, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Mayera TufailDepartment of Community Health Sciences, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Romaina IqbalDepartment of Community Health Sciences, The Aga Khan University, Stadium Road, PO Box 3500, Karachi, 74800, Pakistan.
Aga Khan University · PK

Funding

University Research Council, Aga Khan University Project ID: l74004CHS
6 · The paper itself

Abstract

backgroundType 1 diabetes (T1D) has been increasing globally over the past three decades. Self-monitoring of blood glucose is a challenge in both developed as well as developing countries. Self-management guidelines include maintaining logbooks for blood glucose, physical activity, and dietary intake that affect glycated hemoglobin (HbA1c) and a multitude of life-threatening acute complications. Innovative, cost-effective interventions along with beneficial lifestyle modifications can improve home-based self-monitoring of blood glucose in T1D patients. The overall objective of this study is to evaluate the relationship between maintaining log books for blood glucose levels, reinforcement by e-messages, and/or daily step count and changes in HbA1c. METHODS/

designA randomized controlled trial will enroll participants aged 15 years and above in four groups. Each group of 30 participants will be working with a newly designed standard log book for documenting their blood glucose. The first group will be entirely on routine clinical care, the second group will be on routine care and will receive an additional e-device for recording step count (fit bit), the third group will receive routine care and daily motivational e-messages to maintain the log book, and the fourth group along with routine care will receive an e-device for measuring step count (fit bit) and e-messages about maintaining the log book. Patients will be enrolled from pediatric and endocrine clinics of a tertiary care hospital in Karachi. All groups will be followed up for a period of 6 months to evaluate outcomes. Log book data will be obtained every 3 months electronically or during a patient's clinic visit. HbA1c as a main outcome will be measured at baseline and will be evaluated twice every 3 months. A baseline questionnaire will determine the socio-demographic, nutritional, and physical activity profile of patients. Clinical information for T1D and other co-morbidities for age of onset, duration, complications, hospitalizations, habits for managing T1D, and other lifestyle characteristics will be ascertained. Behavioral modifications for maintaining daily log books as a routine, following e-messages alone, fit bit alone, or e-messages plus using fit bit will be assessed for changes in HbA1c using a generalized estimated equation. DISCUSSION: The proposed interventions will help identify whether maintaining log books for blood glucose, motivational e-messages, and/or daily step count will reduce HbA1c levels.

trial registrationClinicalTrials.gov, NCT03864991. March 6, 2019.

Indexed as

Life StyleAdolescentAdultAgedAged, 80 and overBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlycated HemoglobinGlycemic ControlHumansMaleMiddle AgedMotivationBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHbA1cLog booksSelf-managementStep countType 1 diabetes

Identifiers

PMID32312302
PMCPMC7171752
OpenAlexW3016477315

What OpenQuestion holds

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LicenceCC BY
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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.