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

NCT05453357 | Withdrawn

• 3 other identifiers: 274147UL1TR003107KL2TR003108
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes, Gestational; Diabetes Mellitus Type 2 Pre-Existing

Outcome Measures

Primary Outcomes (2)

• Overall Acceptability of Remote Glucose Monitoring

  The investigator will conduct a t-test (α=.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

• 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 Outcomes (2)

• Changes in patient-physician communication

  Change in baseline Assessment of Care for Chronic Conditions+ (ACC+) score at two weeks postpartum

• Changes in self-efficacy

  Change in baseline self-efficacy score at two weeks postpartum

Study Arms (1)

iGlucose Remote Glucose Monitoring

Patients will be provided with the iGlucose monitor at baseline data collection.

Device: iGlucose

Interventions

iGlucose DEVICE

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

iGlucose Remote Glucose Monitoring

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twenty Marshallese women with pregestational or gestational diabetes.

You may qualify if:

• Women who self-identify as Marshallese
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Related Publications (12)

• 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.

  PMID: 27837454 BACKGROUND

• 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.

  PMID: 29253626 BACKGROUND

• 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.

  PMID: 31087027 BACKGROUND

• 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.

  PMID: 33548591 BACKGROUND

• 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.

  PMID: 31862757 BACKGROUND

• 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.

  PMID: 27591352 BACKGROUND

• 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.

  PMID: 29356835 BACKGROUND

• 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.

  PMID: 24106313 BACKGROUND

• 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.

  PMID: 30406378 BACKGROUND

• 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.

  PMID: 32302521 BACKGROUND

• 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.

  PMID: 29027812 BACKGROUND

• 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.

  PMID: 31147980 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jennifer A Andersen, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: October 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share