The majority of people with type 1 diabetes and multiple daily insulin injections benefit from using continuous glucose monitoring: An analysis based on the GOLD randomized trial (GOLD‐5)

Abstract

Aim To identify responders to continuous glucose monitoring (CGM) in relation to reductions in HbA1c and percentage of time spent in hypoglycaemia after initiation of CGM for individuals with type 1 diabetes treated with multiple daily insulin injections. Materials and Methods We analysed data from 142 participants in the GOLD randomized clinical trial. We evaluated how many lowered their HbA1c by more than 0.4% (>4.7 mmol/mol) or decreased the time spent in hypoglycaemia over 24 hours by more than 20 or 30 minutes, and which baseline variables were associated with those improvements. Results Lower reduction of HbA1c was associated with greater reduction of hypoglycaemia (r = −0.52; P < .0001). During CGM, 47% of participants lowered their HbA1c values by more than 0.4% (>4.7 mmol/mol) than with self‐measurement of blood glucose, and 47% decreased the time spent in hypoglycaemia by more than 20 minutes over 24 hours. Overall, 78% either reduced their HbA1c by more than 0.4% (>4.7 mmol/mol) or the time spent in hypoglycaemia by more than 20 minutes over 24 hours, but only 14% improved both. Higher HbA1c, a lower percentage of time at less than 3.0 or 3.9 mmol/L, a lower coefficient of variation (CV) and a higher percentage of time above 13.9 mmol/L ( P = .016) were associated with greater HbA1c reduction during CGM. The variables associated with a greater reduction of time in hypoglycaemia were female sex, greater time with glucose levels at less than 3.0 mmol/L, higher CV, and higher hypoglycaemia confidence as evaluated by a hypoglycaemic confidence questionnaire. Conclusion The majority of people with type 1 diabetes managed by multiple daily insulin injections benefit from CGM; some experienced reduced HbA1c while others reduced the time spent in hypoglycaemia. These factors need to be considered by healthcare professionals and decision‐makers for reimbursement and diabetes guidelines.

Non‐adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post‐approval observational study

“…baseline HbA1c >86 mmol/mol [>10%]). This agrees with DIAMOND 26 and GOLD 27 studies. Surprisingly, the rates of moderate and severe hypoglycaemia observed during the COACH study were lower than anticipated and far less than previously reported by studies such as the T1D Exchange Clinic Registry 6 or DIALOG.…”

‘You have to use everything and come to some equilibrium’: a qualitative study on hypoglycemia self-management in users of continuous glucose monitor with diverse hypoglycemia experiences

“…Automated insulin delivery systems can offer CGM users additional support, including algorithm-based calculations of predicted future glucose values and automatically adjusted insulin doses to reduce hypoglycemia 3. However, clinically significant hypoglycemia, such as level 2 hypoglycemia (ie, blood glucose levels <54 mg/dL or <3 mmol/L) or severe hypoglycemia (where cognitive or physical dysfunctions develop and assistance for administering treatment is required4), continues to affect about 15%–35% of people with type 1 diabetes (T1D) despite use of these advanced technologies 5–10…”

“…Pathophysiology/complications required 4 ), continues to affect about 15%-35% of people with type 1 diabetes (T1D) despite use of these advanced technologies. [5][6][7][8][9][10] Qualitative studies have expanded knowledge of patients' perspectives on using CGMs, [11][12][13] outlined barriers to hypoglycemia self-management in non-CGM users, 14 15 and improved understanding of the roles of complex cognitive-behavioral 16 17 and psychosocial 18 factors in hypoglycemia management. However, limited research has described the hypoglycemia selfmanagement process among advanced diabetes technology users.…”