Interventional Before/After Study of the Effect of the DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump on Glucose Control of Patients With Type 1 Diabetes in France. The BETTER Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Diabeloop
- 入组人数
- 90
- 试验地点
- 20
- 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 90 adults living with type 1 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 or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system.
The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes.
Data related to their glycemia, complications, usability 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 90 adults living with type 1 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 or competitor open-loop pump. In addition to their standard treatment, all patients will receive a Dexcom G6 coupled with the DBLG1 handset used exclusively to collect the data
- Followed by a 6 weeks period of time (treatment period): Patients will be equipped with the DBLG1 System including the Medisafe With pump in closed loop mode condition
- And finally a 6 weeks optional extension period will be performed (same conditions as for treatment period)
A comparison will be made first between the 6 weeks of study closed loop and the baseline period and second between the extension closed loop and the baseline period of each patient (each patient will be his / her own control) to evaluate statistical subtlety as a secondary objective of the study. In addition, a comparison of treatment vs extension will also be performed.
Visit 1: Inclusion and start of baseline phase for a duration of 2 weeks The investigator collects the dated and signed consents 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
- •Subject who is at least 18 years old,
- •The total daily dose required must be less than 90 units (U),
- •Subject accepting to be treated with 100 U/mL rapid-acting insulin analog,
- •Type 1 diabetes treated for at least 6 months (Patients treated by manual injection with insulin pen - MDI - or by competitor open loop systems or former closed loop patients if they stopped the closed loop system > 3 months before inclusion) with a stable insulin therapy regimen for at least 15 days,
- •HbA1c ≤ 10%,
- •Subject must be affiliated to any kind of social security,
- •Living in an area covered by a GSM (Global System for Mobile Communications) network,
- •Non-isolated patient, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home,
- •Must be able to speak and be literate in French,
- •Having signed the free and informed consent form
排除标准
- •Subject receiving a total daily dose of insulin below 8 U,
- •Subject 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),
- •Subject with severe uncorrected hearing impairment and/or severe uncorrected problems of visual acuity,
- •Subject unable to understand and perform instructions provided by Diabeloop SA,
- •Subject willing to undergo regular MRI, CT or high-frequency electric heat treatment during the study period,
- •Subject who is unwilling or unable to maintain contact with the healthcare professional,
- •Subject using a pacemaker. There is the risk of this device adversely affecting pacemakers and causing them to malfunction,
- •Subject is unable to tolerate tape adhesive around the sensor or pump placements,
- •Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection),
- •Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of inclusion visit, or plans to take any oral, injectable, or IV steroids during the study,
- •Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks,
- •Subject is using DPP-4 inhibitor, GLP-1 agonists, metformin, α-glucosidase inhibitors, thiazolidinediones and/or other SGLT2 inhibitors at time of screening,
- •Diagnosed with chronic kidney disease (glomerular filtration < 30 mL/min or Serum creatinine > 176 µmol/L),
- •Patient who has had a pancreatectomy or who has pancreatic malfunctions or pancreatic islet transplantation or pancreas transplantation,
- •Patient on dialysis,
- •Patient with impaired hepatic functions,
- •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,
- •Pregnant woman 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,
- •Patient under legal protection (curatorship)
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 DBLG1 system 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
- Average dose of insulin used during the entire study(98 days)
- Glucose management indicator (GMI)(98 days)
- Diabetes Treatment Satisfaction (DTSQs) Questionnaire items(98 days)
- Incidence of severe hypoglycemia(98 days)
- Incidence of severe hyperglycemia(98 days)
- Variability of the glucose level(98 days)
- Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire total score(98 days)
- Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Behaviour scale(98 days)
- Scoring of Hypoglycemia Fear Survey (HFS II) questionnaire - Worrieness scale(98 days)
- Percentage of time spent in specific glycemic ranges(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 measured by blood sampling for patients participating in extension study phase(98 days)
- Average sensor glucose level(98 days)
- Percentage of time spent in closed loop mode(98 days)
- Percentage of days with >75% closed loop records(98 days)
- Scoring of Diabetes Treatment Satisfaction (DTSQs) Questionnaire(98 days)
- Scoring of Diabetes Distress Scale (DDS)(98 days)