The Efficacy of Multiple Daily Injection Treatment With an Optimization Algorithm Adjusting Basal-Bolus Parameters in Free-Living Outpatient Conditions in Adults With Type 1 Diabetes

An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of Multiple Daily Injection Treatment With an Insulin Dose Optimization Algorithm in Free-Living Outpatient Conditions in Patients With Type 1 Diabetes

Patrocinadores

Patrocinador principal: McGill University

Fuente McGill University
Resumen breve

The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.

Descripción detallada

The objective of this exploratory study is to test the efficacy of this optimization algorithm with sensor-augmented MDI therapy in improving long-term glucose control, using a randomized parallel study over three months. The optimization algorithm may lead to the automation of physician-adjusted basal rate and Insulin to Carb Ratio (ICR) adjustments.

84 adults with type 1 diabetes will be enrolled in the study, where they will randomly undergo one of two interventions:

1. Sensor-Augmented MDI Therapy: Participants will undergo their usual MDI therapy along with a Freestyle Libre glucose sensor (Abbott Diabetes Care), and a data collection mobile application that collects insulin and meal data.

2. Sensor-Augmented MDI Therapy with the Optimization Algorithm: Participants will undergo MDI therapy with a Freestyle Libre glucose sensor (Abbott Diabetes Care) and a data collection mobile application that collects insulin and meal data. Every week, participants will have their insulin doses adjusted by the optimization algorithm's recommendations.

Estado general Not yet recruiting
Fecha de inicio February 1, 2020
Fecha de Terminación November 1, 2021
Fecha de finalización primaria November 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in HbA1c levels 3 months
Resultado secundario
Medida Periodo de tiempo
1. Percentage of time of sensor glucose levels spent: Through the last 7 days of study completion
2. Percentage of overnight time (23:00-7:00) of sensor glucose levels: Through the last 7 days of study completion
3. Percentage of daytime (7:00-23:00) of sensor glucose levels: Through the last 7 days of study completion
4. Standard deviation of glucose levels. Through the last 7 days of study completion
5. Total insulin delivery. Through the last 7 days of study completion
6. Mean sensor glucose level during: Through the last 7 days of study completion
Inscripción 84
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: MDI (multiple daily injections) with Optimization Algorithm

Descripción: Multiple daily injections (MDI) (slow acting insulin and Rapid acting insulin) therapy involves four or more daily insulin injections. Once or twice daily, a long acting insulin is injected as a basal dose. These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection. This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day. Furthermore, multiple insulin bolus doses are injected at every meal each day using rapid or short acting insulin. These injections are administered before meals and are calculated using patients' ICRs and meal carbohydrate quantities.

Etiqueta de grupo de brazo: MDI with Basal-Bolus Optimization Algorithm

Elegibilidad

Criterios:

Inclusion Criteria:

1. Males and females ≥ 18 years of age

2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

3. Undergoing multiple daily injection therapy.

4. HbA1c ≥ 8% in the last 2 months.

Exclusion Criteria:

1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

2. Failure to comply with the study protocol or with team's recommendations.

3. Injection of isophane insulin (NPH) or any intermediate-acting insulin

4. Current or ≤ 1 month use of other antihyperglycemic agents (Sodium-Glucose Co-transporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).

5. Pregnancy

6. Severe diabetic ketoacidosis episode within one month of admission

7. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator

8. Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery

9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Emilie Palisaitis, B.Sc., MEng.

Teléfono: +1 (514) 553-5500

Teléfono Ext.: 3238

Email: [email protected]

Ubicación
Instalaciones: McGill University Health Centre
Ubicacion Paises

Canada

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Sensor-Augmented MDI Therapy

Tipo: No Intervention

Descripción: Participants will undergo their usual multiple daily injection (MDI) therapy along with a Freestyle Libre glucose sensor (Abbott Diabetes Care), and a data collection mobile application that collects insulin and meal data.

Etiqueta: MDI with Basal-Bolus Optimization Algorithm

Tipo: Experimental

Descripción: Participants will undergo multiple daily injection (MDI) therapy with a Freestyle Libre glucose sensor (Abbott Diabetes Care) and a data collection mobile application that collects insulin and meal data. Every week, participants' insulin doses will be updated by the optimization algorithm's recommendations.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: This is an open-label, randomized, two-way, parallel study to compare the glucose control between sensor-augmented MDI therapy and our basal-bolus optimizing algorithm over 3 months. Adults with type 1 diabetes will be enrolled in the study, where they will randomly undergo one of two interventions: Sensor-Augmented MDI Therapy MDI with Optimization Algorithm

Propósito primario: Treatment

Enmascaramiento: Single (Participant)

Fuente: ClinicalTrials.gov