Continuous Glucose Monitoring and Diabetes

Diabetes Clinical Trial

Official title:

Improving Glucose Control and Self-Management in Adults With Type 2 Diabetes From Health Disparate Groups Using Continuous Glucose Monitoring and Education Support

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05840250
• Other study ID #: Pro2022-0402
• Status: Suspended
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: May 14, 2024

Study information

• Verified date: January 2024
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a longitudinal single-arm prospective study design. Adult patients who are African American or Hispanic with type 2 diabetes mellitus will be recruited to participate in this study. The goal of the study is to determine if the use of a continuous glucose monitoring system will improve diabetes management in persons from health disparity background.

The subjects will be closely monitored for the first 3 months as they utilize the continuous glucose monitor and engage in diabetes education classes. They will then be followed for an additional 3 months to determine if they are able to maintain the same glucose control as experienced for the initial 3 months.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 34
• Est. completion date: May 14, 2024
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult subjects with type 2 diabetes mellitus =18 years

• African-American or Hispanic

• with A1c =8% to =12%

Exclusion Criteria:

• Patients with type 1 diabetes,

• pregnant,

• End-Stage Renal Disease,

• recent use of any CGM within the last 12 months,

• on steroid therapy and history of adhesive allergy.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Continuous Glucose Monitoring and Education Support
Participants will be provided with a device to monitor their blood glucose (Abbott Free Style Libre2 Flash CGM system) along with educational materials to better understand and manage their diabetes and other supporting services. Pre and post intervention surveys will be implemented. Participants will be closely monitored for 3 months and then followed up for 3 more months for a total of 6-month participation.

Locations

Country	Name	City	State
United States	Hackensack Univeristy Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

References & Publications (16)

Bergenstal RM, Kerr MSD, Roberts GJ, Souto D, Nabutovsky Y, Hirsch IB. Flash CGM Is Associated With Reduced Diabetes Events and Hospitalizations in Insulin-Treated Type 2 Diabetes. J Endocr Soc. 2021 Feb 2;5(4):bvab013. doi: 10.1210/jendso/bvab013. eCollection 2021 Apr 1. — View Citation

Gal RL, Cohen NJ, Kruger D, Beck RW, Bergenstal RM, Calhoun P, Cushman T, Haban A, Hood K, Johnson ML, McArthur T, Olson BA, Weinstock RS, Oser SM, Oser TK, Bugielski B, Strayer H, Aleppo G. Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring. J Endocr Soc. 2020 Jun 23;4(9):bvaa076. doi: 10.1210/jendso/bvaa076. eCollection 2020 Sep 1. — View Citation

Golden SH, Brown A, Cauley JA, Chin MH, Gary-Webb TL, Kim C, Sosa JA, Sumner AE, Anton B. Health disparities in endocrine disorders: biological, clinical, and nonclinical factors--an Endocrine Society scientific statement. J Clin Endocrinol Metab. 2012 Sep;97(9):E1579-639. doi: 10.1210/jc.2012-2043. Epub 2012 Jun 22. — View Citation

Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20. — View Citation

Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017 Jun;8(3):573-586. doi: 10.1007/s13300-017-0255-6. Epub 2017 Apr 11. — View Citation

Hill-Briggs F, Adler NE, Berkowitz SA, Chin MH, Gary-Webb TL, Navas-Acien A, Thornton PL, Haire-Joshu D. Social Determinants of Health and Diabetes: A Scientific Review. Diabetes Care. 2020 Nov 2;44(1):258-79. doi: 10.2337/dci20-0053. Online ahead of print. No abstract available. — View Citation

Karter AJ, Parker MM, Moffet HH, Gilliam LK, Dlott R. Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes. JAMA. 2021 Jun 8;325(22):2273-2284. doi: 10.1001/jama.2021.6530. — View Citation

Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444. — View Citation

Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626. — View Citation

Polonsky WH, Fisher L, Hessler D, Edelman SV. Development of a New Measure for Assessing Glucose Monitoring Device-Related Treatment Satisfaction and Quality of Life. Diabetes Technol Ther. 2015 Sep;17(9):657-63. doi: 10.1089/dia.2014.0417. Epub 2015 Apr 29. — View Citation

Rodriguez JE, Campbell KM. Racial and Ethnic Disparities in Prevalence and Care of Patients With Type 2 Diabetes. Clin Diabetes. 2017 Jan;35(1):66-70. doi: 10.2337/cd15-0048. No abstract available. — View Citation

Rothman RL, Malone R, Bryant B, Wolfe C, Padgett P, DeWalt DA, Weinberger M, Pignone M. The Spoken Knowledge in Low Literacy in Diabetes scale: a diabetes knowledge scale for vulnerable patients. Diabetes Educ. 2005 Mar-Apr;31(2):215-24. doi: 10.1177/0145721705275002. — View Citation

Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943. — View Citation

Vigersky R, Shrivastav M. Role of continuous glucose monitoring for type 2 in diabetes management and research. J Diabetes Complications. 2017 Jan;31(1):280-287. doi: 10.1016/j.jdiacomp.2016.10.007. Epub 2016 Oct 14. — View Citation

Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. doi: 10.2337/dc11-1438. Epub 2011 Nov 18. — View Citation

Yaron M, Roitman E, Aharon-Hananel G, Landau Z, Ganz T, Yanuv I, Rozenberg A, Karp M, Ish-Shalom M, Singer J, Wainstein J, Raz I. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166. Epub 2019 Apr 29. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c - Marker of overall glucose control	A1c levels measured at 12 weeks post enrollment will be compared to the baseline A1c level (measured at enrollment).	At 3 months post enrollment
Primary	A1c - Marker of overall glucose control	A1c levels measured at 24 weeks post enrollment will be compared to the baseline A1c level (measured at enrollment).	At 6 months post enrollment
Primary	Glycemic control	To investigate the effect of the Continuous Glucose Monitoring (CGM) device and educational support on the Glycemic control. Glycemic control will be measured based on the percent time that glucose is on target vs off target. On target is within the normal range of 70-180 mg/dL. Off target includes: <54 mg/dL (critical low glucose); < 70 mg/dL (low glucose); >180 mg/dL (high glucose); and >250 mg/dL (very high).; The range at 12 weeks post enrollment will be compared to the baseline data that will be collected after the first 14 days (2 weeks).	At 3 months post enrollment
Primary	Glycemic control	To investigate the effect of the Continuous Glucose Monitoring (CGM) device and educational support on the Glycemic control. Glycemic control will be measured based on the percent time that glucose is on target vs off target. On target is within the normal range of 70-180 mg/dL. Off target includes: <54 mg/dL (critical low glucose); < 70 mg/dL (low glucose); >180 mg/dL (high glucose); and >250 mg/dL (very high).; The range at 24 weeks post enrollment will be compared to the baseline data that will be collected after the first 14 days (2 weeks).	At 6 months post enrollment
Secondary	Blood pressure	To determine if CGM and diabetes education affects Blood pressure. Blood pressure will be measured before the CGM/education begins and at the 3 month follow up appointment.	At 3 months post enrollment
Secondary	Weight	To determine if CGM and diabetes education affects weight. Weight will be measured before the CGM/education begins and at the 3 month follow up appointment.	At 3 months post enrollment
Secondary	BMI	To determine if CGM and diabetes education affects BMI. BMI will be calculated before the CGM/education begins and at the 3 month follow up appointment.	At 3 months post enrollment
Secondary	ER visit	To determine if CGM and diabetes education glycemic control as demonstrated by ER visit due to hypoglycemia or hyperglycemic events.	For the 3 months post enrollment
Secondary	Hospital admissions	To determine if CGM and diabetes education glycemic control as demonstrated by hospital admission due to hypoglycemia or hyperglycemic events.	For the 3 months post enrollment
Secondary	Glycemic control - Episodes of hypoglycemia	To determine if CGM and diabetes education glycemic control as demonstrated by the number of episodes of hypoglycemia occurred during the 3 months post enrollment.; The number of hypoglycemic events will be recorded at baseline (2 weeks) and compared to the data collected at the 12 weeks timepoint.	For the 3 months post enrollment
Secondary	Diabetes knowledge	To determine if CGM and diabetes education Diabetes knowledge. Diabetes knowledge will be measured before the CGM/education begins (baseline) and at the 3 month follow up appointment. Diabetes knowledge will be measured using a 10-item survey called "The SKILLD Knowledge Assessment Scale" (Spoken Knowledge in Low Literacy patients with Diabetes (SKILLD)). The scale ranges from 0% to 100% with higher scores demonstrating better knowledge.	At 3 months post enrollment
Secondary	Diabetes self-care	To determine if CGM and diabetes education affects Diabetes self-care. Diabetes self-care will be measured before the CGM/education begins (baseline) and at the 3 month follow up appointment. Diabetes self-care will be measured using a 11-item survey and reflects on activities for the past 7 days. The survey used is called "Summary of Diabetes Self-Care Activities" . The survey includes five regimen areas: Diet, Exercise, Blood-Glucose Testing, Foot-Care, and Smoking Status and each area is scored separately based on the number of days an event took place (from 0 for 0 days to 7 for each day).	At 3 months post enrollment
Secondary	Diabetes distress	To determine if CGM and diabetes education affects Diabetes distress. Diabetes distress will be measured before the CGM/education begins (baseline) and at the 3 month follow up appointment. Diabetes distress will be measured using a survey. The 17-item survey called "Diabetes Distress Screening (DDS17)" assesses the difficulties living with diabetes as it relates to disease.; management, support, emotional burden and access to care. Each item is scored from 1 (No distress) to 6 (distress). The overall score is calculated as the mean of all items and higher the number the higher the distress level reported.	At 3 months post enrollment
Secondary	Satisfaction with CGM device	Using a satisfaction scale, the satisfaction with the CGM device will be measured at 3 months post enrollment. A 15-item Survey will be used to evaluate treatment burden/satisfaction with using a continuous glucose monitor. The survey contains four subscales (Openness, Emotional Burden, Behavioral Burden, and Worthwhileness) as well as a total score. Each can be obtained by calculating the mean item response score for the groups of items below. Each item is scored between 1 and 5 with 1 being strongly disagree and 5 being strongly agree. Higher scores indicate greater satisfaction.	At 3 months post enrollment