Optimizing Metabolic Control in Type 1 Diabetes With Multiple Daily Insulin Injections - Flash Glucose Monitoring, Carbohydrate Counting With Automated Bolus Calculation, or Both?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Time in normoglycemia
研究概览
简要总结
This study aims to compare the effect of flash glucose monitoring (FGM) with traditional self-monitoring of blood glucose (SMBG) with or without carbohydrate counting and automated bolus calculation, in patients with type 1 diabetes and poor metabolic control.
The investigators will include in total 200 patients recruited from 5 clinical sites in the Capital Region of Copenhagen.
The patients will be randomized into four groups; A) Standard diabetes training, i.e. group training in in general diabetes health issues, B) Group training in carbohydrate counting and automated bolus calculation, the app MySugr will be taught and downloaded, C) Group training as in group A, and instructed to use FGM, D) Group training as in group B, and besides training in the use of the app MySugr, also instructed to use FGM.
All patients are followed for 26 weeks with 6 clinical visits, group training (1 visit) and 2 telephone consultations.
The primary outcome is time spent in normoglycemia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •HbA1c > 53 mmol/mol
- •Type 1 diabetes more than 1 year
- •Treated with basal and bolus insulin. Basal insulin can be taken once or twice daily. The percentage basal/bolus insulin should as judged by the investigator cover the patient's real need for basal insulin - if he or she is not eating and taking bolus
- •Patients may or may not have knowledge on carbohydrate counting
- •Patients may or may not have any experience with continuous glucose monitoring or FGM
- •Patients have a personal smart phone
- •Patients attend the outpatient clinic in one of the five study sites included in the study
排除标准
- •Use of an automatic bolus calculator on a daily basis within the last three months
- •Daily use of continuous glucose monitoring or FGM on a daily basis within the last three months
- •Use of insulin pump
- •Use of Neutral Protamine Hagedorn insulin as long acting insulin (Insulatard, Humulin Retard) within the last three months
- •Pregnant, breastfeeding, plan to get pregnant
- •Gastroparesis
- •Severe diabetes complications including proliferative retinopathy and myocardial infarction within the last six months
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation as e.g. alcohol and drug abuse
- •Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- •Inability to understand the individual information and to give informed consent
研究组 & 干预措施
D) Carbohydrate counting, automated bolus calculation, FGM
Group training as group B. A more sophisticated education concept will be developed for how FGM should be used to adjust settings and suggestions from the automated bolus calculator (MySugr app).
干预措施: Flash glucose monitoring (FGM) (Device)
B) Carbohydrate counting, automated bolus calculation
干预措施: Carbohydrate counting, automated bolus calculation (Device)
A) Standard diabetes training (control)
More specifically, group training in general diabetes health issues, how to do experienced based dosing, how to handle sick days, exercise etc. in general terms. The group will not be taught in carbohydrate counting or bolus calculation. They will be encouraged to measure SMBG at least 4 times daily with patients own preferred glucose meter.
Patients will be offered 6 months treatment with FGM after study end.
C) Flash glucose monitoring (FGM)
Group training with same content as for group A.
干预措施: Flash glucose monitoring (FGM) (Device)
D) Carbohydrate counting, automated bolus calculation, FGM
Group training as group B. A more sophisticated education concept will be developed for how FGM should be used to adjust settings and suggestions from the automated bolus calculator (MySugr app).
干预措施: Carbohydrate counting, automated bolus calculation (Device)
结局指标
主要结局
Time in normoglycemia
时间窗: 26 weeks
Difference in time in normoglycemic range 4-10 mmol/l at end of study measured by 2 weeks blinded FGM between group A (control group) and C (FGM) (min/day).
次要结局
- Blinded FGM hyperglycemia(26 weeks)
- Severe hypoglycemia(26 weeks)
- Diabetes treatment satisfaction(26 weeks)
- Total insulin dose(26 weeks)
- Total basal insulin dose(26 weeks)
- Hypoglycemia(26 weeks)
- Diabetes quality of life(26 weeks)
- Blinded FGM glycemic variability(26 weeks)
- HbA1c(26 weeks)
- Diabetes distress(26 weeks)
- Diabetes empowerment(26 weeks)
- Urinary albumin/excretion rate(26 weeks)
- Blinded FGM hypoglycemia(26 weeks)
- Insulin boluses(26 weeks)
- Personality traits(26 weeks)
- Body weight(26 weeks)
研究者
Kirsten Nørgaard
Principal Investigator
Steno Diabetes Center Copenhagen