Smartphone Utilization for Glucose Monitoring and Antenatal Reporting (SUGAR)

• ClinicalTrials.gov Identifier: NCT03504592
• Recruitment Status: Completed
• First Posted: April 20, 2018
• Last Update Posted: February 13, 2020
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Lisa Gray, University of Rochester

Study Description

Brief Summary:

This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes; Pregestational Diabetes	Behavioral: Completion of Glucose logs	Not Applicable

Detailed Description:

This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Utilizing mHealth to Improve Diabetes in an Obstetric Population
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Glooko App; Glooko application and meter compatibility device (if required)	Behavioral: Completion of Glucose logs; Glucose logs will be assessed by provider for completeness and accuracy
Active Comparator: Traditional Care; Traditional clinic reporting system: paper/MyChart/emailed glucose logs	Behavioral: Completion of Glucose logs; Glucose logs will be assessed by provider for completeness and accuracy

Outcome Measures

Primary Outcome Measures :

1. Completeness and accuracy of blood glucose record [ Time Frame: Every 2 weeks through study completion, up to 42 weeks ]
   The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.

Secondary Outcome Measures :

1. Patient Satisfaction [ Time Frame: Once prior to exiting the study, an average of 42 weeks ]
   Responses to patient satisfaction survey
2. Glucose values at goal [ Time Frame: Every 2 weeks through study completion, up to 42 weeks ]
   % of glucose values at goal during the study period
3. % Change in Hemoglobin A1C [ Time Frame: Once prior to exiting the study, up to 42 weeks ]
   % of change in values of HbA1C during the study period
4. Clinic visits [ Time Frame: through study completion, up to 42 weeks ]
   Number of clinic visits during the study period
5. Unscheduled health care access episodes [ Time Frame: through study completion, up to 42 weeks ]
   Number of unanticipated or unscheduled health care visits during the study period

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Patients must be pregnant to be enrolled in this study
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.

Exclusion Criteria:

• Not English speaking, does not have smartphone, unable to consent.

Contacts and Locations

Locations

United States, New York

UR Medicine Obstetrics and Gynecology

Rochester, New York, United States, 14620

Sponsors and Collaborators

University of Rochester

More Information

• Responsible Party: Lisa Gray, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03504592
• Other Study ID Numbers: RSRB00068149
• First Posted: April 20, 2018
• Last Update Posted: February 13, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications