Randomized Clinical Study to Evaluate the Bio-Psychosocial Impact of a Mobile App for Diabetes ("SOCIAL DIABETES") and a SMARTMETER® (A. MENARINI DIAGNOSTICS) in the Care of People With Diabetes Mellitus Type 1 and Its Associated Costs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- glycosylated hemoglobin
研究概览
简要总结
Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1 through a randomized randomized study during 6 months of follow-up.
详细描述
Randomized study in people with type 1 diabetes in intensive insulin therapy MDI with analogues and with HbA1c> 7% to the usual clinical follow-up options (CG) vs use of Social Diabetes App (GI) for 6 months.
The current clinical research project considers the effectiveness of a free diabetes app with a CE mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC (Near Field Communication) technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1.
The substitution of the usual face-to-face medical visit every 3-4 months by the incorporation of an app system has a similar effect in terms of glycemic control (measured through HbA1c) in patients with DM1 treated with multiple doses of insulin per day (MDI). ) and inadequate metabolic control (HbA1c> 7%). In addition, it could save costs and consumption of health resources, and improve both the quality of life and the satisfaction of people with DM1.
The present study will be carried out under the usual conditions of clinical practice.
No pharmacological intervention, other than the usual clinical practice, will be applied to the included patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DM1 over 1 year evolution.
- •Age ≥18 and <65 years.
- •HbA1c prior to the inclusion of the study> 7%.
- •Intensive insulin treatment with MDI in basal-bolus regimen.
- •Patients with basic digital skills and with 3G mobile phone and NFC technology.
- •Patients who have given their informed consent in writing.
排除标准
- •Treatment with subcutaneous insulin infusor (ISCI)
- •Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- •Pregnancy or pregnancy planning.
- •Diabetes mellitus type
- •Severe psychological alterations.
- •Absence of collaboration (informed consent).
- •Patients who are participating in other clinical studies.
研究组 & 干预措施
Group that uses the Social Diabetes App (research group)
This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month
干预措施: Social Diabetes App (Device)
Usual clinical monitoring group (control group)
This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments
干预措施: Usual clinical monitoring group (Control group) (Device)
结局指标
主要结局
glycosylated hemoglobin
时间窗: 6 month
Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.
Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire.
时间窗: 6 month
34 items to analyze the biopsychosocial impact measured through the quality of life questionnaire (DQol) of a mobile application (Social Diabetes) in the care of people with DM1.
次要结局
- Number of severe hypoglycaemia(6 month)
- Episodes of ketosis(6 month)
- Mean blood glucose(6 month)
- Scale of adherence to treatment in patients with diabetes type 1(6 month)
- Standard deviation(6 month)
- Number of mild hypoglycaemia(6 month)
- Episodes of ketoacidosis(6 month)
- Number of hospital admissions for glycemic decompensation(6 month)
- Number of hyperglycemia(6 month)
- Diabetes treatment satisfaction questionnaire ( DTSQ)(6 month)
- Fear of hypoglycemia: Questionnaire FH-15(6 month)
- Diabetes distress scale. DDS(6 month)
研究者
Soledad Ruiz de Adana
Maria Soledad Ruiz de Adana
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud