Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus

NCT06716671 | Active Not Recruiting

• 1 other identifier: 24/166-P
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Diabetes Mellitus (DM) is a chronic disease that affects millions of people worldwide. More than 95% of cases are type 2 diabetes mellitus (T2DM). In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. These devices implanted under the skin allow continuous measurement of glucose levels monitoring glucose trends and the rate at which glucose level rise and fall without the need for capillary glycaemias test. While studies demostrate the effectiveness of CGM devices in controlling glucose levels in adults with T2DM, there is no evidence related to quality of life in this patients. Hypothesis: The use of CGM in people with T2DM improves their quality of life, reduces distress about the disease, reduces fear of hypoglycaemia, increases detection of hypoglycaemia, and improves metabolic control. Objectives: To assess quality of life, diabetes distress, fear of hypoglycaemia, detection of hypoglycaemia, and metabolic control in people with T2DM before and after the use of CGM sensors. Methodology: Prospective observational pre-post unblinded study. Adults with type 2 diabetes using a CGM device in the primary care setting will be followed for 12 months. They will be asked to complete 5 questionnaires at baseline, and 4 questionnaires at 3, 6 and 12 months. No other activity that differs from usual clinical practice will be performed. Data analysis: a descriptive analysis of the main study variables will be carried out and the differences in the data before and after the intervention will be analysed using the chi-square test for qualitative variables, and the Student's t-test for quantitative variables. Statistical significance will be accepted at a p-value \< 0.05. Applicability and relevance: The results of the study will provide information on whether CGM devices improve quality of life and glycaemic control in people with type 2 diabetes. With these results it will be possible to assess whether it is beneficial to extend funding for CGM devices to more of the population than is currently the case.

Conditions

Continuous Glucose Monitoring; Quality of Life; Type 2 Diabetes Mellitus (T2DM)

Keywords

Continuous Glucose Monitoring; Quality of Life; Primary Care; Hypoglycemia; Type 2 Diabetes Mellitus; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Difference between pre and post "diabetes-related quality of life (EsDQOL)" questionnaire.

  A validated scale is used to measure diabetes-related quality of life. It consists of 43 questions with answers on a Likert scale from 1 to 5. The higher the score, the worse the quality of life.

  0, 3, 6 and 12 months

Secondary Outcomes (4)

• Difference between pre and post "diabetes-related distress scale (DDS17)".

  0, 3, 6 and 12 months

• Difference between pre and post "hypoglycaemia fear test (EsHFS)".

  0, 3, 6 and 12 months

• Difference between pre and post "undetected hypoglycemia test (Test de Clarke)".

  0, 3, 6 and 12 months

• Difference between pre and post metabolic control.

  2 weeks, 3 months, 6 months, 12 months.

Study Arms (1)

Type 2 diabetes and continuous glucose monitoring Tarragona

People with type 2 diabetes and intensive insulin therapy who are using a continuous glucose monitoring sensor for the first time in the Camp de Tarragona health region.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is adults in an industrialised country with a diagnosis of type 2 diabetes with intensive insulin regimen who will start using a CGM sensor. Participants will be recruited from primary care centres in the Camp de Tarragona health region following inclusion and exclusion criteria. Depending on the location of the primary care centre, the population may be from an urban, semi-urban, or rural setting.

You may qualify if:

• Treatment with intensive insulin therapy (basal bolus regimen with 3 or more daily doses of insulin).
• Perform 6 or more daily capillary glycaemia determinations.
• Be willing to use a CGM device for at least 70% of the time.
• Undergo training on the use of the CGM device by the centre's CGM referent.
• Agree to participate in the study.

You may not qualify if:

• Cognitive impairment measured by Pfeiffer test with a score of 3 or more errors.
• Previous use of a CGM device.
• Pregnancy.
• Being institutionalised.
• Having participated in another research study related to diabetes mellitus within the last year.
• Not having proper handling of the CGM device: inability to download glycaemic control data, inability to keep the sensor attached to the skin, not understanding how it works, etc.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, 08007, Spain

Location

Related Publications (10)

• Chesser H, Srinivasan S, Puckett C, Gitelman SE, Wong JC. Real-Time Continuous Glucose Monitoring in Adolescents and Young Adults With Type 2 Diabetes Can Improve Quality of Life. J Diabetes Sci Technol. 2024 Jul;18(4):911-919. doi: 10.1177/19322968221139873. Epub 2022 Nov 23.

  PMID: 36416098 BACKGROUND

• Moreno-Fernandez J, Gomez FJ, Galvez Moreno MA, Castano JP. Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial. J Diabetes Res. 2016;2016:4171789. doi: 10.1155/2016/4171789. Epub 2016 Nov 29.

  PMID: 28004007 BACKGROUND

• Gilbert TR, Noar A, Blalock O, Polonsky WH. Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. Diabetes Technol Ther. 2021 Mar;23(S1):S35-S39. doi: 10.1089/dia.2020.0666.

  PMID: 33470882 BACKGROUND

• Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 Diabetes--More Common Than You Think: A Continuous Glucose Monitoring Study. J Diabetes Sci Technol. 2015 Apr 27;9(5):999-1005. doi: 10.1177/1932296815581052.

  PMID: 25917335 BACKGROUND

• Rodriguez de Vera Gomez P, Mateo Rodriguez C, Rodriguez Jimenez B, Hidalgo Sotelo L, Peinado Ruiz M, Torrecillas Del Castillo E, Ruiz-Aranda D, Serrano Olmedo I, Candau Martin A, Martinez-Brocca MA. Impact of Flash Glucose Monitoring on the Fear of Hypoglycemia Phenomenon in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):478-487. doi: 10.1089/dia.2023.0370. Epub 2024 Feb 22.

  PMID: 38315507 BACKGROUND

• Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P; RESCUE Trial Investigators. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1224-1232. doi: 10.1210/jc.2017-02498.

  PMID: 29342264 BACKGROUND

• Rodbard D. Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Diabetes Technol Ther. 2017 Jun;19(S3):S25-S37. doi: 10.1089/dia.2017.0035.

  PMID: 28585879 BACKGROUND

• Kieu A, King J, Govender RD, Ostlundh L. The Benefits of Utilizing Continuous Glucose Monitoring of Diabetes Mellitus in Primary Care: A Systematic Review. J Diabetes Sci Technol. 2023 May;17(3):762-774. doi: 10.1177/19322968211070855. Epub 2022 Feb 1.

  PMID: 35100891 BACKGROUND

• Hirsch IB. Introduction: History of Glucose Monitoring. In: Role of Continuous Glucose Monitoring in Diabetes Treatment. Arlington (VA): American Diabetes Association; 2018 Aug. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK538968/

  PMID: 34251770 BACKGROUND

• McGill JB, Ahmann A. Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies. Diabetes Technol Ther. 2017 Jun;19(S3):S3-S12. doi: 10.1089/dia.2017.0090.

  PMID: 28585875 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sergi Rodríguez-Soler, Nurse

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

ES (1)