Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women

Diabetes, Gestational Clinical Trial

Official title:

Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women With Pregnancies Complicated by Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05453357
• Other study ID #: 274147
• Secondary ID: UL1TR003107KL2TR
• Status: Not yet recruiting
• Start date: August 15, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: July 2023
• Source: University of Arkansas
• Contact: Jennifer A Andersen, PhD
• Phone: 479-713-8300
• Email: jaandersen[@]uams.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall objective is to test the feasibility and acceptability of a remote glucose monitoring program among Marshallese women with PGDM (pre-gestational diabetes mellitus) or GDM (gestational diabetes mellitus) and with limited English proficiency.

Description:

iGlucose Remote Monitoring System. iGlucose is a remote patient monitoring system. The iGlucose monitor works by analyzing a small amount of blood placed on a strip that is inserted into the monitor, similar to a standard glucometer. The iGlucose monitor will show the patient their glucose reading and will automatically send the patient's glucose reading to a database via cellular networks when the patient removes the strip from the device. The iGlucose monitor does not require any recording on the part of the patient. The iGlucose data is managed through a HIPAA-compliant Amazon Web Services (AWS) database maintained by Smartmeter. The data is available to the provider to monitor the patient's blood glucose levels accurately and in a timely manner, allowing for treatment to be adjusted. The data is available for the physician during every patient contact for review and discussion.

Patients will be provided with the iGlucose monitor at the baseline data collection. A trained bilingual research assistant will review the iGlucose guide with the participant, provide training on the use of the monitor, taking a blood glucose reading with the monitor, and the patient will use the iGlucose monitor once in front of the research assistant. The patient will receive a packet of information in their language of choice (English and/or Marshallese). The packet will include information on how to use the monitor (including the iGlucose Guide) and contact information if there are any problems with the monitor during the study. The patient will use the monitor as instructed by their healthcare team to monitor their blood glucose. The patient will return the equipment at the completion of the study.

The participant will provide their physician's information as part of the study, so that the investigators may provide access to the iGlucose blood glucose readings through the electronic guidebook and contact the physician post-intervention to complete a survey.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women who self-identify as Marshallese

• 18 years of age or older

• =30 weeks pregnant

• Receive prenatal care at University of Arkansas for Medical Sciences (UAMS) and partner clinics and hospitals

• Have used a paper log for at least two weeks

• Have a diagnosis of PGDM (pre-gestational diabetes mellitus) or GDM (gestational diabetes mellitus).

Exclusion Criteria:

• Women who are unable to use a glucometer by themselves

• Have not used a paper log

• Have a continuous glucose monitor

• More than 30 weeks pregnant

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational

Intervention

Device:
• iGlucose
The patient will use the monitor as instructed by their healthcare team to monitor their blood glucose.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Center for Advancing Translational Sciences (NCATS)

References & Publications (12)

Alexopoulos AS, Blair R, Peters AL. Management of Preexisting Diabetes in Pregnancy: A Review. JAMA. 2019 May 14;321(18):1811-1819. doi: 10.1001/jama.2019.4981. — View Citation

American Diabetes Association. 14. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S183-S192. doi: 10.2337/dc20-S014. — View Citation

Andersen JA, Scoggins D, Michaud T, Wan N, Wen M, Su D. Racial Disparities in Diabetes Management Outcomes: Evidence from a Remote Patient Monitoring Program for Type 2 Diabetic Patients. Telemed J E Health. 2021 Jan;27(1):55-61. doi: 10.1089/tmj.2019.0280. Epub 2020 Apr 17. — View Citation

Berger H, Gagnon R, Sermer M, Basso M, Bos H, Brown RN, Bujold E, Cooper SL, Gagnon R, Gouin K, McLeod NL, Menticoglou SM, Mundle WR, Roggensack A, Sanderson FL, Walsh JD. Diabetes in Pregnancy. J Obstet Gynaecol Can. 2016 Jul;38(7):667-679.e1. doi: 10.1016/j.jogc.2016.04.002. Epub 2016 May 12. Erratum In: J Obstet Gynaecol Can. 2017 Jun;39(6):509. — View Citation

Bogdanet D, Egan A, Reddin C, Kirwan B, Carmody L, Dunne F. ATLANTIC DIP: Despite insulin therapy in women with IADPSG diagnosed GDM, desired pregnancy outcomes are still not achieved. What are we missing? Diabetes Res Clin Pract. 2018 Feb;136:116-123. doi: 10.1016/j.diabres.2017.12.003. Epub 2017 Dec 15. — View Citation

Diamond L, Izquierdo K, Canfield D, Matsoukas K, Gany F. A Systematic Review of the Impact of Patient-Physician Non-English Language Concordance on Quality of Care and Outcomes. J Gen Intern Med. 2019 Aug;34(8):1591-1606. doi: 10.1007/s11606-019-04847-5. Epub 2019 May 30. — View Citation

Goyal S, Cafazzo JA. Mobile phone health apps for diabetes management: current evidence and future developments. QJM. 2013 Dec;106(12):1067-9. doi: 10.1093/qjmed/hct203. Epub 2013 Oct 8. — View Citation

Guo H, Zhang Y, Li P, Zhou P, Chen LM, Li SY. Evaluating the effects of mobile health intervention on weight management, glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus. J Endocrinol Invest. 2019 Jun;42(6):709-714. doi: 10.1007/s40618-018-0975-0. Epub 2018 Nov 7. — View Citation

McElfish PA, Rowland B, Long CR, Hudson J, Piel M, Buron B, Riklon S, Bing WI, Warmack TS. Diabetes and Hypertension in Marshallese Adults: Results from Faith-Based Health Screenings. J Racial Ethn Health Disparities. 2017 Dec;4(6):1042-1050. doi: 10.1007/s40615-016-0308-y. Epub 2016 Nov 11. — View Citation

Mora P, Buskirk A, Lyden M, Parkin CG, Borsa L, Petersen B. Use of a Novel, Remotely Connected Diabetes Management System Is Associated with Increased Treatment Satisfaction, Reduced Diabetes Distress, and Improved Glycemic Control in Individuals with Insulin-Treated Diabetes: First Results from the Personal Diabetes Management Study. Diabetes Technol Ther. 2017 Dec;19(12):715-722. doi: 10.1089/dia.2017.0206. Epub 2017 Oct 13. — View Citation

Schaefer-Graf U, Napoli A, Nolan CJ; Diabetic Pregnancy Study Group. Diabetes in pregnancy: a new decade of challenges ahead. Diabetologia. 2018 May;61(5):1012-1021. doi: 10.1007/s00125-018-4545-y. Epub 2018 Jan 22. — View Citation

Sushko K, Menezes HT, Strachan P, Butt M, Sherifali D. Self-management education among women with pre-existing diabetes in pregnancy: A scoping review. Int J Nurs Stud. 2021 May;117:103883. doi: 10.1016/j.ijnurstu.2021.103883. Epub 2021 Jan 20. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Acceptability of Remote Glucose Monitoring	The investigator will conduct a t-test (a=.05) using the post-intervention scores on the glucose monitoring satisfaction survey given to participants; a higher mean score demonstrating more satisfaction with the iGlucose remote monitoring system (range 0-60). The semi-structured interview qualitative data will be analyzed to explore the feasibility and acceptability of the intervention qualitatively. The investigator will use descriptive statistics to assess physician satisfaction with the iGlucose remote monitoring system. Given the small size of the pilot study, the investigator will conduct a review of the disaggregated data to determine the individual differences between pre- and post-intervention scores on the glucose monitoring satisfaction measure to better understand the changes in glucose monitoring satisfaction.	Change in baseline glucose monitoring satisfaction score at two weeks postpartum
Primary	Overall Feasibility of Remote Glucose Monitoring	The investigator will use summary statistics to document and compare actual recruitment and retention rates with the target rates. A recruitment rate of =70% of all eligible participants, a retention rate through postnatal data collection of =80%, and an engagement rate of =75% of recommended daily glucose checks completed during the enrollment period will indicate feasibility.	Retention at two weeks postpartum
Secondary	Changes in patient-physician communication	The investigator will conduct repeated measures t-test (a=.05) using pre- and post-intervention patient satisfaction with patient-physician communication scores from the Assessment of Care for Chronic Conditions+ (ACC+) survey measures. The repeated measures t-test will assess whether the post-intervention mean ACC+ score (range 0-100) is significantly higher than the pre-intervention score, indicating increased patient satisfaction with patient-physician communication.	Change in baseline Assessment of Care for Chronic Conditions+ (ACC+) score at two weeks postpartum
Secondary	Changes in self-efficacy	The investigator will conduct repeated measures t-test (a=.05) using pre- and post-intervention self-efficacy scores from the Diabetes Management Self-Efficacy Scale (DMSES) (range 0-80).	Change in baseline self-efficacy score at two weeks postpartum