To determine whether the use of continuous glucose monitoring (CGM) without confirmatory blood glucose monitoring (BGM) measurements is as safe and effective as using CGM adjunctive to BGM in adults ...with well-controlled type 1 diabetes (T1D).
A randomized noninferiority clinical trial was conducted at 14 sites in the T1D Exchange Clinic Network. Participants were ≥18 years of age (mean 44 ± 14 years), had T1D for ≥1 year (mean duration 24 ± 12 years), used an insulin pump, and had an HbA
≤9.0% (≤75 mmol/mL) (mean 7.0 ± 0.7% 53 ± 7.7 mmol/mol); prestudy, 47% were CGM users. Participants were randomly assigned 2:1 to the CGM-only (
= 149) or CGM+BGM (
= 77) group. The primary outcome was time in range (70-180 mg/dL) over the 26-week trial, with a prespecified noninferiority limit of 7.5%.
CGM use averaged 6.7 ± 0.5 and 6.8 ± 0.4 days/week in the CGM-only and CGM+BGM groups, respectively, over the 26-week trial. BGM tests per day (including the two required daily for CGM calibration) averaged 2.8 ± 0.9 and 5.4 ± 1.4 in the two groups, respectively (
< 0.001). Mean time in 70-180 mg/dL was 63 ± 13% at both baseline and 26 weeks in the CGM-only group and 65 ± 13% and 65 ± 11% in the CGM+BGM group (adjusted difference 0%; one-sided 95% CI -2%). No severe hypoglycemic events occurred in the CGM-only group, and one occurred in the CGM+BGM group.
Use of CGM without regular use of confirmatory BGM is as safe and effective as using CGM with BGM in adults with well-controlled T1D at low risk for severe hypoglycemia.
Youth with type 1 diabetes (T1D) require 24/7 access to T1D management supplies. This study aims to characterize access to T1D supplies when youth are away from home. We emailed a comprehensive ...survey to 4756 parents of T1D Exchange participants <18 years old; 752 respondents completed the survey (83% completed by parents). Results were age-stratified: <6 (N=21), 6-12 (N=271) and 13-18 (N=459). The majority of youth carry rapid-acting insulin most of the time or always, yet the proportion decreases as age increases (Table 1). ≥80% of injection users carry an extra pen or syringe, while >55% of pump users carry an extra infusion set. Among CGM users, 100% of ≤6 years old vs. 67% of adolescents carry a receiver or phone; 33% of 13-18 years old never carry an extra sensor. 38% of youth ≤6 years old vs. 27% of teens carry blood or urine ketone testing supplies. In total, 64% reported carrying glucose tablets or gel; 87% carry another rapid acting carbohydrate. 64% of respondents carry glucagon, again decreasing across adolescence. Over 2/3 carry at least one form of T1D identification. Technology to optimize glycemic control and detect/prevent acute complications of T1D have improved. Yet, adolescents are less likely than younger T1D-affected youth, to carry supplies to detect, prevent and/or treat acute events. These findings call for novel and ongoing T1D emergency preparedness training to strike a balance between supervision and autonomy of adolescents.
Disclosure
M. Quinn: None. R. Bailey: None. N.C. Foster: None. J. Simmons: None. E. Eyth: None. H. Rodriguez: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Pharm Corp, MannKind Corporation, Medtronic MiniMed, Inc. Research Support; Spouse/Partner; Medtronic MiniMed, Inc. Research Support; Self; Takeda Pharmaceutical Company Limited. Other Relationship; Self; Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc. S. Corathers: None. C.J. Levy: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Allergan. N.M. Sheanon: None. R.M. Wasserman: None. D. Sparling: None. D. Adkins: None. A. Albanese-O'Neill: None. D.J. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation.
Funding
The Leona M. and Harry B. Helmsley Charitable Trust
We aim to understand the impact of HbA1c variability, as measured by SD-HbA1c, on risk of microalbuminuria in T1D population. An analysis was performed utilizing data of 8,680 participants in the T1D ...Exchange Clinic Registry (50% female, 86% non-Hispanic white, mean age 34 years, mean diabetes duration 14 years at enrollment) who met the following criteria: ≥2 clinic visit records, T1D duration ≥1 year at enrollment, age of diagnosis ≥10 years old and no known renal disease (including no microalbuminuria) at the time of registry enrollment. Median number of albuminuria and HbA1c measures were 4 and 21 per participant, respectively. Microalbuminuria was present during follow-up in 562 (6.5%) participants. Median intrapersonal mean HbA1c and SD-HbA1c were 7.8% and 0.6% respectively. Participants with high HbA1c variability had shorter time to first microalbuminuria (p<0.001, Figure 1a.) Those with high (≥50th percentile) mean HbA1c and high SD-HbA1c also had shorter diabetes duration prior to first reported microalbuminuria compared to high mean-HbA1c but low SD-HbA1c (p<0.001, Figure 1b). HbA1c variability relates to risk of microalbuminuria in T1D; its relationship to other outcomes should be studied.
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