Dataset Information

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

ABSTRACT:

Importance

Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.

Objective

To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.

Design, setting, and participants

Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.

Interventions

Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79).

Main outcomes and measures

The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.

Results

Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).

Conclusions and relevance

Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.

Trial registration

ClinicalTrials.gov Identifier: NCT03263494.

SUBMITTER: Laffel LM

PROVIDER: S-EPMC7298603 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

Laffel Lori M LM Kanapka Lauren G LG Beck Roy W RW Bergamo Katherine K Clements Mark A MA Criego Amy A DeSalvo Daniel J DJ Goland Robin R Hood Korey K Liljenquist David D Messer Laurel H LH Monzavi Roshanak R Mouse Thomas J TJ Prahalad Priya P Sherr Jennifer J Simmons Jill H JH Wadwa R Paul RP Weinstock Ruth S RS Willi Steven M SM Miller Kellee M KM

JAMA 20200601 23

<h4>Importance</h4>Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.<h4>Objective</h4>To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.<h4>Design, setting, and participants</h4>Ran ...[more]

PMID: 32543683

Similar Datasets

Project description:ImportanceGlycemic control often deteriorates during adolescence and the transition to young adulthood for patients with type 1 diabetes. The inability to manage type 1 diabetes effectively during these years is associated with poor glycemic control and complications from diabetes in adult life.ObjectiveTo determine the effect of daily financial incentives on glucose monitoring adherence and glycemic control in adolescents and young adults with type 1 diabetes.Design, setting, and participantsThe Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes (BE IN CONTROL) study was an investigator-blinded, 6-month, 2-arm randomized clinical trial conducted between January 22 and November 2, 2016, with 3-month intervention and follow-up periods. Ninety participants (aged 14-20) with suboptimally controlled type 1 diabetes (hemoglobin A1c [HbA1c] >8.0%) were recruited from the Diabetes Center for Children at the Children's Hospital of Philadelphia.InterventionsAll participants were given daily blood glucose monitoring goals of 4 or more checks per day with 1 or more level within the goal range (70-180 mg/dL) collected with a wireless glucometer. The 3-month intervention consisted of a $60 monthly incentive in a virtual account, from which $2 was subtracted for every day of nonadherence to the monitoring goals. During a 3-month follow-up period, the intervention was discontinued.Main outcomes and measuresThe primary outcome was change in HbA1c levels at 3 months. Secondary outcomes included adherence to glucose monitoring and change in HbA1c levels at 6 months. All analyses were by intention to treat.ResultsOf the 181 participants screened, 90 (52 [57.8%] girls) were randomized to the intervention (n = 45) or control (n = 45) arms. The mean (SD) age was 16.3 (1.9) years. The intervention group had significantly greater adherence to glucose monitoring goals in the incentive period (50.0% vs 18.9%; adjusted difference, 27.2%; 95% CI, 9.5% to 45.0%; P = .003) but not in the follow-up period (15.3% vs 8.7%; adjusted difference, 3.9%; 95% CI, -2.0% to 9.9%; P = .20). The change in HbA1c levels from baseline did not differ significantly between groups at 3 months (adjusted difference, -0.08%; 95% CI, -0.69% to 0.54%; P = .80) or 6 months (adjusted difference, 0.03%; 95% CI, -0.55% to 0.60%; P = .93).Conclusions and relevanceAmong adolescents and young adults with type 1 diabetes, daily financial incentives improved glucose monitoring adherence during the incentive period but did not significantly improve glycemic control.Trial registrationclinicaltrials.gov Identifier: NCT02568501.

Project description:ImportanceContinuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.ObjectiveTo determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.Design, setting, and participantsThis randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.InterventionsRandom assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).Main outcomes and measuresThe primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.ResultsAmong 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.Conclusions and relevanceAmong adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.Trial registrationClinicalTrials.gov Identifier: NCT03566693.

Project description:Tight glycemic control can potentially reduce morbidity and mortality in the intensive care unit but increases the risk of hypoglycemia. The most effective means to avoid hypoglycemia is to obtain frequent blood glucose samples, but this increases the burden to nursing staff. The objective of this study was to assess the ability of a real-time continuous glucose monitor to reduce hypoglycemia (blood glucose <60 mg/dL [3.3 mmol/L]) during standard care or tight glycemic control effected with a proportional integral derivative insulin titration algorithm.Real-time continuous glucose monitor profiles obtained from an ongoing prospective randomized trial of tight glycemic control were retrospectively analyzed to determine whether the continuous glucose measure had prevented instances of hypoglycemia.Cardiac intensive care unit.Children 3 yrs of age or younger undergoing cardiac surgery were studied.Intravenous insulin infusion and rescue glucose guided by the real-time continuous glucose monitor and the proportional integral derivative algorithm in the tight glycemic control arm (n = 155; target glucose 80-110 mg/dL [4.4-6.1 mmol/L]) and the real-time continuous glucose monitor in the standard care arm (n = 156).No reduction in hypoglycemia was observed with real-time continuous glucose monitor alarms set at 60 mg/dL (3.3 mmol/L) (zero of 19 occurrences of blood glucose <60 mg/dL [3.3 mmol/L] detected); 18 of 40 subsequent incidences of hypoglycemia were detected after the alarm threshold was increased to 70 mg/dL (3.9 mmol/L). In the tight glycemic control arm, eight incidences were reduced in duration and an additional eight events were prevented with intravenous glucose. In the standard care arm, three of nine occurrences of hypoglycemia were detected with the duration reduced in all cases. On average, one to two false hypoglycemia alarms were observed in each patient.The real-time continuous glucose monitor in combination with proportional integral derivative control can reduce hypoglycemia during tight glycemic control. The real-time continuous glucose monitor can also reduce hypoglycemia during standard care. However, false alarms increase the overall nursing workload.

Dataset Information

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets