Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya.

NCT05944731 | Unknown

• 1 other identifier: NC007
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user's arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour. In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs. This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in Kenya.

Conditions

Type 1 Diabetes

Keywords

Continuous Glucose Monitoring Devices

Outcome Measures

Primary Outcomes (1)

• Impact of continuous and intermittent CGM used on blood glucose levels in comparison to standard of care in people living with type 1 diabetes

  Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms

  15 months

Secondary Outcomes (4)

• Impact of continuous and intermittent CGM use on the stability of blood glucose concentrations related to diabetes

  15 months

• Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications.

  15 months

• Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care & care givers perspective

  15 months

• Cost of continuous and intermittent CGM from a user and provider perspective

  15 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.

Device: Continuous glucose monitor

Arm 2

EXPERIMENTAL

Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months.

Device: Continuous glucose monitor

Arm 3

NO INTERVENTION

Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.

Interventions

Continuous glucose monitor DEVICE

Continuous Glucose Monitoring (CGM) device is a small electronic tool that you put on your skin, and it tells you the amount of glucose in your body. It is different from a finger prick glucose machine in that you do not need to prick your finger to get some blood to put on the reader paper like you have to do for a finger prick glucose machine.

Also known as: Freestyle Libre

Arm 1; Arm 2

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. People living with T1 diabetes with HbA1c levels ≥10% (with at least 1 measurement over 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics.
• \. The child/adolescent that the person is a care giver to is enrolled in the study.
• \. Healthcare provider at the study sties engaged in diabetes care provision related to the study.

You may not qualify if:

• People living with type 1 diabetes under 4 years of age
• People diagnosed with Type 1 diabetes within the last 2 years.
• People who have used a CGM in the last 18 months prior to enrollment
• People living with type 2 diabetes.
• Known pregnancy at the time of study enrolment.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Kenya Diabetes Management and Information Centre (DMI): collaborator

Related Publications (14)

• Maiorino MI, Signoriello S, Maio A, Chiodini P, Bellastella G, Scappaticcio L, Longo M, Giugliano D, Esposito K. Effects of Continuous Glucose Monitoring on Metrics of Glycemic Control in Diabetes: A Systematic Review With Meta-analysis of Randomized Controlled Trials. Diabetes Care. 2020 May;43(5):1146-1156. doi: 10.2337/dc19-1459.

  PMID: 32312858 BACKGROUND

• Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.

  PMID: 28118454 BACKGROUND

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Welsh JB, Gao P, Derdzinski M, Puhr S, Johnson TK, Walker TC, Graham C. Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems. Diabetes Technol Ther. 2019 Mar;21(3):128-132. doi: 10.1089/dia.2018.0374. Epub 2019 Jan 25.

  PMID: 30681379 BACKGROUND

• Brown JVE, Ajjan R, Siddiqi N, Coventry PA. Acceptability and feasibility of continuous glucose monitoring in people with diabetes: protocol for a mixed-methods systematic review of quantitative and qualitative evidence. Syst Rev. 2022 Dec 9;11(1):263. doi: 10.1186/s13643-022-02126-9.

  PMID: 36494845 BACKGROUND

• McClure Yauch L, Velazquez E, Piloya-Were T, Wainaina Mungai L, Omar A, Moran A. Continuous glucose monitoring assessment of metabolic control in east African children and young adults with type 1 diabetes: A pilot and feasibility study. Endocrinol Diabetes Metab. 2020 Jun 8;3(3):e00135. doi: 10.1002/edm2.135. eCollection 2020 Jul.

  PMID: 32704558 BACKGROUND

• Palmer T, Jennings HM, Shannon G, Salustri F, Grewal G, Chelagat W, Sarker M, Pelletier N, Haghparast-Bidgoli H, Skordis J. Improving access to diabetes care for children: An evaluation of the changing diabetes in children project in Kenya and Bangladesh. Pediatr Diabetes. 2022 Feb;23(1):19-32. doi: 10.1111/pedi.13277. Epub 2021 Dec 3.

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• Bowen GA. Naturalistic inquiry and the saturation concept: a research note. Qualitative Research 2008; 8: 137-152.

  BACKGROUND

• Marban-Castro E, Muhwava L, Kamau Y, Safary E, Rheeder P, Karsas M, Kemp T, Freitas J, Carrihill M, Dave J, Katambo D, Kimetto J, Allie R; Kenya ACCEDE study group; South Africa ACCEDE study group; Ndungu J, Sigwebela N, Akach D, Girdwood S, Erkosar B, Nichols BE, Haldane C, Vetter B, Shilton S. Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya. Trials. 2024 May 21;25(1):331. doi: 10.1186/s13063-024-08132-7.

  PMID: 38773658 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Beatrice Vetter

  FIND, the global alliance for diagnostics

  STUDY DIRECTOR

Central Study Contacts

Yvonne Kamau

CONTACT

+721535786; yvonne.kamau@finddx.org

Cathy Haldane

CONTACT

+27 82 372 6496; Cathy.Haldane@finddx.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three arm pragmatic randomized controlled study

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 13, 2023
• Study Start: February 5, 2024
• Primary Completion: November 30, 2024
• Study Completion: April 28, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share