The Effects of Continuous Glucose Monitoring and Connected Insulin Pens on Glycemic Control in Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 10
- 主要终点
- Change in Haemoglobin A1c
研究概览
简要总结
The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c >53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care.
详细描述
This study is a 12 months open-label randomized controlled trial.
Subjects with basal/bolus insulin treated T2DM and HbA1c >53 mmol/mol are randomized to:
A (control): standard care with disposable insulin pens and fingerprick glucose measurement or B (intervention): Novopen6 for bolus insulin and glucose measurement with Freestyle Libre 2.
Due to the nature of the treatments it is not possible to perform a blinded study.
Randomization in ratio 1:1 will be formed electronically in a REDCap database.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Type 2 DM.
- •- HbA1c > 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
- •- Contact to diabetes clinic for ≥ 6 months.
- •- Insulin treatment ≥ 12 months.
- •- Basal insulin and bolus insulin at least for one meal every day.
- •- Bolus insulin is insulin aspart.
- •- Stable insulin treatment (change 10 % or less) and no introduction of other antihyperglycemic agents (oral or GLP1 analogue) for at least 2 months before randomization.
- •- Considered to be technically and intellectually capable of using isCGM and smart pen.
- •- Can communicate in Danish.
- •- Informed consent including acceptance to share glucose data from the Libreview platforms.
- •- The patient has a smart phone suitable for Libre and NOVOpen6 data registration.
排除标准
- •- Individual goal for HbA1c is reached (even if > 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
- •- Fasting C-peptide < 370 pmol/l.
- •- Actual treatment with CGM or previous use of CGM for more than four weeks or < 6 months before recruitment. No actual or previous use of connected pen.
- •- One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
- •- Considered unable to participate due to frequent cancellation of appointments.
- •- Ongoing steroid treatment or expected intermittent treatment of more than 14 days' duration.
- •- Pregnant or planning pregnancy.
- •- Participating in other trials.
- •- Clinical conditions interfering with interpretation of HbA1c (phlebectomy, bleeding or haemolytic disorders, erythropoietin treatment, known haemoglobin variants, etc.) or continuous intake of high dose of vitamin C (> 1000 mg), salicylic acid (650 mg daily), Salazopyrin or Dapsone.
- •- Allergic reaction to the adhesive used in the isCGM.
研究组 & 干预措施
1 (Standard care)
In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens
2 (CGM and connected pen)
In this arm the patients switch from glucose measurement with fingerprick to continuous glucose monitoring and they switch from standard insulin pen for bolusinsulin to connected pen for bolusinsulin
干预措施: Continuous glucose monitoring and use of connected insulinpen for bolus insulin (Device)
结局指标
主要结局
Change in Haemoglobin A1c
时间窗: Baseline and follow-up after 12 months
Change between groups in Haemoglobin A1c (mmol/mol) from baseline to follow-up A prespecified exploratory analysis is planned for: male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings. A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
次要结局
- Standard deviation(Baseline and follow-up after 12 months)
- Change in Time below range(Baseline and follow-up after 12 months)
- Fraction of patients with increased number of bolus insulin per day(Baseline and follow-up after 12 months)
- Change in Time with rapid glucose change(Baseline and follow-up after 12 months)
- Change in Time above range(Baseline and follow-up after 12 months)
- Mean glucose(Baseline and follow-up after 12 months)
- Change in CV(Baseline and follow-up after 12 months)
- Change in ARRC(Baseline and follow-up after 12 months)
- Change Time in range(Baseline and follow-up after 12 months)
研究者
Klavs Würgler Hansen
Professor
Central Jutland Regional Hospital