ABSTRACT
OBJECTIVE: To compare the efficacy of an education program for people with diabetes and insulin pump treatment (INPUT) in a randomized controlled trial (RCT) to the effectiveness in an implementation trial (IT). METHODS: 135 people with diabetes on insulin pump treatment (CSII) underwent structured education with INPUT under RCT-conditions, 191 people with diabetes on CSII underwent structured education with INPUT under IT-conditions. Baseline characteristics and treatment outcomes at the 6-month follow-up were compared. RESULTS: At baseline, RCT-participants were younger (42.7 ± 14.2 vs. 47.2 ± 14.1 years, p = 0.005), had higher HbA1c-values (8.3 ± 0.8% vs. 7.8 ± 1.2%, p = 0.001) and had more diabetes-related distress (27.8 ± 16.4 vs 22.4 ± 14.4, p = 0.002). At follow-up, INPUT results were comparable under the RCT and IT settings. After adjustment for baseline HbA1c, reduction of HbA1c in the IT was significantly greater than in the RCT (Δ0.17%; 95% CI 0.023-0.319%, p = 0.024). Participants with higher HbA1c-levels, more diabetes-related distress and more hypoglycemia problems were most likely to benefit from INPUT regardless of the trial setting. CONCLUSIONS: Efficacy of the INPUT program for people with CSII was demonstrated under RCT- and routine care conditions. PRACTICE IMPLICATIONS: Education with the INPUT program is effective not only under standardized RCT conditions but also under conditions of routine care.
Subject(s)
Comparative Effectiveness Research , Diabetes Mellitus/drug therapy , Diabetes Mellitus/psychology , Hypoglycemic Agents/therapeutic use , Insulin Infusion Systems , Patient Education as Topic/methods , Adolescent , Adult , Aged , Female , Glycated Hemoglobin/analysis , Humans , Male , Middle AgedABSTRACT
BACKGROUND: People with diabetes on intensive insulin therapy need sufficient glycaemic control to prevent the onset or progression of diabetic complications. The burden of multiple daily blood glucose self-testing can be lessened by novel diabetes technology like flash glucose monitoring systems which provide more information compared to self-monitoring of blood glucose. Despite this delivered additional information studies are showing no significant effect on HbA1c reduction, but a reduced time spent in a hypoglycaemic glucose range. We assume that users of these devices need additional education and training to integrate the delivered information into treatment decisions. Therefore, FLASH, an education and treatment programme, was developed. The programme evaluation follows herein. METHODS/DESIGN: Patients are recruited through 40 diabetes outpatient study centres located across Germany. They will be randomly assigned to participate in the education and treatment programme (intervention group) or to obtain treatment as usual (control group). All patients have to give blood samples and to answer a bench of questionnaires during baseline assessment, at the end of the intervention, and 6 months after the end of the intervention. Physicians will be asked to declare some additional clinical data (such as details of the diabetes therapy) for every patient at every one of the three assessment points. DISCUSSION: This study is conducted as a randomised controlled trial to test the hypothesis that the newly developed education and treatment programme combined with the use of a flash glucose monitoring device (intervention group) is superior to reduce HbA1c compared to the use of flash glucose monitoring alone (control group). The first results will be expected in 2018. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03175315 . Registered on 2 May 2017.
Subject(s)
Blood Glucose Self-Monitoring/instrumentation , Blood Glucose/drug effects , Diabetes Mellitus/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Patient Education as Topic , Adolescent , Adult , Aged , Biomarkers/blood , Blood Glucose/metabolism , Diabetes Mellitus/blood , Diabetes Mellitus/diagnosis , Diabetes Mellitus/psychology , Equipment Design , Female , Glycated Hemoglobin/metabolism , Health Behavior , Health Knowledge, Attitudes, Practice , Humans , Hypoglycemic Agents/adverse effects , Insulin/adverse effects , Male , Middle Aged , Multicenter Studies as Topic , Predictive Value of Tests , Randomized Controlled Trials as Topic , Self Care , Time Factors , Treatment Outcome , Young AdultABSTRACT
INTRODUCTION: Published data on prevalence of disturbed eating behavior in youth with type 1 diabetes are heterogeneous. This study assesses the prevalence rate of disturbed eating behavior in a representative German sample of children and adolescents with type 1 diabetes. The prevalence rate is compared to the one published for a national sample of healthy peers. Furthermore prospects as well as limits of a generic screening tool used to identify disturbed eating behavior are compared to those of a diabetes specific screening tool. MATERIAL AND METHODS: A total of 246 children and adolescents (age: 11-19 years) with type 1 diabetes, from 6 pediatric diabetes centers in Germany, completed the generic SCOFF questionnaire and the diabetes specific Diabetes Eating Problem Survey-Revised (DEPS-R) to assess their eating behavior. Prevalence data were compared to representative data from a nationwide survey in Germany (KiGGS-study). RESULTS: A total of 16.3% of the children and adolescents with type 1 diabetes scored above the SCOFF cut-off (≥ 2) (24.2% of the girls and 8.9% of the boys). The percentages in the healthy controls were 28.9% for girls and 15.2% for boys. Compared to this the prevalence of disturbed eating behavior was lower in the diabetes group (p=0.017 and p<0.001). According to the diabetes specific DEPS-R 11.2% of the boys and 13.2% of the girls with type 1 diabetes practiced insulin-purging. The association between SCOFF-scores and the items referring to insulin-purging in DEPS-R, was stronger for girls than for boys (r=0.437 vs. r=0.144). Among the young people with type 1 diabetes DEPS-R-scores showed stronger associations to the quality of metabolic control (HbA1c) than the SCOFF (boys: r=0.357 vs. r=0.217 and girls: r=0.368 vs. r=0.131). DISCUSSION: Children and adolescents with type 1 diabetes are not more frequently affected by disturbed eating behavior than their healthy peers. Particularly boys with type 1 diabetes practicing insulin-purging, are not reliably detected by a generic screening tool. CONCLUSION: As part of long-term care a diabetes specific screening tool should be used to identify adolescents with type 1 diabetes and disturbed eating behavior more reliably.
