Multicentric Before/After Study to Assess the Efficacy and Safety of DBL-4pen Mobile Application on Glycemic Control in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Diabeloop
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Percentage of time spent in 70 - 180 mg/dL glycemic range
研究概览
简要总结
This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.
After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection), the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps, in addition to the Dexcom G6 CGM. An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application.
The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes.
Data related to efficacy of DBL-4pen, global safety of DBL-4pen, compliance with recommended insulin injections, satisfaction with the system and quality of life will be collected.
The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).
详细描述
This study conducted in 40 adults living with type 2 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.
The study periods are as follows:
- 2 weeks of baseline period at home will be performed. During this baseline period, all patients will use their current therapy (MDI). In addition to their standard treatment, all patients will receive a Dexcom G6 and a smartphone. During this study period, the smartphone will be used to install the Dexcom G6 application in order to collect the glycemia data. The patients will make equivalent therapeutic decisions based on the values of the CGM used in the study (Dexcom G6) as if using their usual CGM.
- Followed by a 6-week treatment period: the patients will install the DBL-4pen application on the smartphone provided for the study with help of the research team and they will receive two Mallya caps for their insulin pens.
- Followed by an optional 6-week extension period with treatment for patients agreeing to pursue the use of the DBL-4pen system.
For each patient, a comparison will be made first between treatment and baseline periods and second between extension and baseline periods. In addition, a comparison of treatment vs extension periods will also be performed. Each patient will be his / her own control.
Visit 1: Inclusion and start of baseline phase for a duration of 2 weeks The investigator collects the dated and signed informed consent forms of patients who meet all inclusion and non-inclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Device-related inclusion criteria:
- •Patients under basal-bolus scheme for type 2 diabetes
- •Patients aged ≥ 18 years old
- •Patients using rapid-acting analog and long-acting analog that are compatible with Mallya cap (Lispro, Detemir, Aspart, Glargine, Glulisine) with a stable insulin therapy regimen for at least the past 90 days (no modification of the number of injections and no more than 10% variation of the total daily dose)
- •Patients using insulin with a concentration 100 U/mL
- •Study-specific inclusion criteria:
- •No significant modification of diabetes treatment during the 3 months before inclusion (i.e., no introduction or removal of any pharmacological treatment, and no education training during this period), except for a possible modification for an equivalent insulin compatible with Mallya at least 15 days before inclusion
- •Patients having an HbA1c ≤ 10%
- •Patients who agree to use Dexcom G6 as CGM
- •Patients living in an area covered by phone network
- •Patients must be affiliated to any kind of social security
- •Patients must be able to speak and be literate in French
- •Non-isolated patients, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home
- •Having signed the free and informed consent form
- •Subject equipped with a CGM for at least the past 90 days
- •Non-inclusion criteria
- •Device-related non-inclusion criteria
- •Patients with Total Daily Dose (TDD) < 10 U
- •Patients suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids).
- •Patients with severe uncorrected hearing impairment and/or severe uncorrected proble- ms of visual acuity.
- •Patients unable to understand and perform instructions provided by Diabeloop SA.
- •Patients who are unwilling or unable to maintain contact with the healthcare professional.
- •Use of any insulin that is not 100U/mL rapid-acting insulin analog, 100U/mL long-acting insulin analog.
- •Study-specific non-inclusion criteria:
- •Patients with type 1 diabetes
- •Patients not feeling hypoglycemia (hypoglycemia unawareness)
- •Patients who had an episode of severe hypoglycemia or a hypoglycemic coma in the past year while being equipped with any glucose sensor
- •Patients not accepting to stay in France during the study
- •Pregnant woman (verified by urine HCG pregnancy test for any woman wishing to participate in the protocol and of childbearing age < 60 year) or woman of childbearing potential in the absence of an effective method of contraception or if she does not agree to continue using contraception for the duration of the study
- •Subjects under legal protection (guardianship, curatorship)
- •Patients whose pancreas has been removed or is not functioning altogether
- •Patients with islet/pancreas transplants.
- •Patients with severely altered renal function (creatinine clearance <30 mL/min).
- •Patients on dialysis
- •Critically ill patients
- •Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
排除标准
- 未提供
结局指标
主要结局
Percentage of time spent in 70 - 180 mg/dL glycemic range
时间窗: 56 days
Impact of the use of DBL-4pen on the time spent in the target 70-180 mg/dL during the main treatment period compared to baseline, in percentage.
次要结局
- Percentage of time spent in specific glycemic ranges(98 days)
- Variability of the glucose level(98 days)
- Number of adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated serious adverse device effects(98 days)
- Evolution of HbA1c for patients accepting the extension phase(98 days)
- Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Behaviour scale(98 days)
- Scoring of Diabetes Distress Scale (DDS)(98 days)
- Incidence of severe hypoglycemia(98 days)
- Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire total score(98 days)
- Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Worrieness scale(98 days)
- Scoring of Diabetes Treatment Satisfaction (DTSQs) Questionnaire(98 days)
- Mean CGM glycemia(98 days)
- Glucose management indicator (GMI)(98 days)
- Difference between recommended and administered insulin dose(98 days)
- Incidence of severe hyperglycemia(98 days)
- Difference between the number of boluses recommended by the application and the number of boluses administered by the patient(98 days)
- Diabetes Treatment Satisfaction (DTSQs) Questionnaire items(98 days)