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NCT05944731Felfüggesztve

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

Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya: A Three-arm Pragmatic Randomized Study on the Effectiveness, Feasibility, Acceptability, and Cost.

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 21.

Megadott ok: funding issues

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Felfüggesztve
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
246 (tervezett)
Első benyújtás
2023. jún. 13.
Kezdés
2023. szept. 3.
Elsődleges befejezés
2024. okt. 10.
Fő szponzor
Foundation for Innovative New Diagnostics, Switzerland
NCT-szám
NCT05944731

Ki nem vehet részt

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Korábbi kezelés

  • People who have used a CGM in the last 18 months prior to enrollment

Más betegség

  • People diagnosed with Type 1 diabetes within the last 2 years.
  • People living with type 2 diabetes.

Életkor

  • People living with type 1 diabetes under 4 years of age

Egyéb

  • Participants are excluded from the Study if any of the following exclusion criteria apply:
  • Known pregnancy at the time of study enrolment.

Kiket keres a vizsgálat

  • Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
  • 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.
    • Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply:
  • The child/adolescent that the person is a care giver to is enrolled in the study.
    • Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply:
  • Healthcare provider at the study sties engaged in diabetes care provision related to the study.

Életkor a regiszterben: 4 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Diabetes Management & Information Centre (DMI)NairobiKenyaIsmeretlen állapot

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