Sustained Intensive Treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI

Abstract

Continuous glucose monitoring (CGM) reduces HbA 1c and time spent in hypoglycemia in people with type 1 diabetes (T1D) treated with multiple daily insulin injections (MDI) when evaluated over shorter time periods. It is unclear to what extent CGM improves and helps to maintain glucose control, treatment satisfaction, diabetes distress, hypoglycemic concerns, and overall well-being over longer periods of time. RESEARCH DESIGN AND METHODSThe GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in people with T1D treated with MDI. People completing the trial (n 5 141) were invited to participate in the current SILVER extension study in which 107 patients continued CGM treatment over 1 year along with the support of a diabetes nurse every 3 months. RESULTSThe primary end point of the change in HbA 1c over 1.0-1.5 years of CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA 1c of 0.35% (95% CI 0.19-0.50, P < 0.001). Time spent in hypoglycemia <3.0 mmol/L (54 mg/dL) and <4.0 mmol/L (72 mg/dL) decreased from 2.1% to 0.6% (P < 0.001) and from 5.4% to 2.9% (P < 0.001), respectively. Overall well-being (World Health Organization 5-item well-being index, P 5 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire, P < 0.001), and hypoglycemic confidence (P < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry, P 5 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale, P 5 0.06). From randomization and screening in GOLD, HbA 1c was lowered by 0.45% (P < 0.001) and 0.68% (P < 0.001) after 2.3 and 2.5 years, respectively. CONCLUSIONSThe SILVER study supports beneficial long-term effects from CGM on HbA 1c , hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI.

Flash Glucose Monitoring in the Netherlands: Increased monitoring frequency is associated with improvement of glycemic parameters

“…Continuous Glucose Monitoring (CGM), either by real time Continuous Glucose Monitoring (rt-CGM) or by Flash Glucose Monitoring (FLASH), allows a more frequent assessment of glucose concentrations in the interstitial fluid and also provides information on glucose trends. CGM is changing diabetes management and often contributes to increased quality of life, treatment satisfaction, better and more stable glycemic control and improved short term outcomes [4][5][6][7][8][9][10][11].…”

Development and Psychometric Assessment of a Manufacturer Independent Knowledge Questionnaire on Real Time Continuous Glucose Monitoring for insulin-treated People with Diabetes

“…The 122 members of diabetes team (age 46 (11) years; mean (SD)) and the 111 people with insulin-treated diabetes (age 42 (14) years, diabetes duration 20 (14) years, insulin treatment with pumps 64 %, previous usage of CGM 38 %, HbA 1c 8.0 % [95 %-KI 7.7-8.3]; 64 mmol/mol [60-67]) had different levels of experiences using rtCGM-systems. The internal consistency (Cronbach's alpha) of the knowledge test was 0.92 for the whole sample, for people with diabetes 0.94, and for members of the diabetes teams 0.84.…”

“…Compared to conventional blood glucose measurement, which people with diabetes perform 4-8 times a day, CGM provides information about the current glucose value and its course at any time. Moreover, the alarm function of real-time glucose monitoring systems (rtCGM) provides additional safety to avoid hypo-and hyperglycemia [11][12][13].…”

“…Im Vergleich zur konventionellen Blutglukosemessung, die Menschen mit Diabetes 4-bis 8-mal täglich durchführen, liefert CGM zu jedem Zeitpunkt Informationen über den aktuellen Glukosewert und dessen Verlauf. Außerdem bietet die Alarmfunktion der Real-Time-Glukosemonitoring-Systeme (rtCGM) eine zusätzliche Sicherheit zur Vermeidung von Hypo-und Hyperglykämien [11][12][13].…”

“…Ergebnisse Die 122 Mitglieder der Diabetesteams (Alter 46 (11) Jahre; Mittelwert (SD)) und auch die 111 Personen mit insulinbehandeltem Diabetes (Alter 42 (14) Jahre, Diabetesdauer 20 (14) Jahre, Therapie mit einer Insulinpumpe 64 %, Nutzung eines CGM-Systems 38 %, HbA -Wert 8,0 % 1c [95 %-KI 7,7-8,3]; 64 mmol/mol [KI 60-67]) hatten einen unterschiedlichen Erfahrungsstand im Umgang mit rtCGM-Systemen. Die interne Konsistenz des Fragebogens (Cronbach's alpha) betrug für die gesamte Stichprobe 0,92, für die Personen mit Diabetes 0,94 und für die Mitglieder der Diabetesteams 0,84.…”