Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial
Yogish C. KudvaLori M. LaffelSue A. BrownDan RaghinaruJordan E. PinskerLaya EkhlaspourCarol J. LevyLaurel H. MesserBoris KovatchevJohn LumRoy W. BeckLinda Gonder‐FrederickStacey M. AndersonEmma EmoryMary VoelmleKatie ConshafterKim MorrisMary C. OliveriHarry MitchellKayla CalvoChristian WakemanMarc D. BretonElvira IsganaitisLouise Ambler-OsbornEmily FlintKenny KimLindsay RoethkeMei Mei ChurchCamille AndréMolly PiperDavid W. LamGrenye O’MalleyCamilla LevisterSelassie OgyaaduJessica LovettVinaya SimhaVikash DadlaniShelly McCrady-SpitzerCorey ReidKanchan KumariR. Paul WadwaGregory P. ForlenzaG. Todd AlonsoRobert H. SloverEmily JostCari BergetLindsey TowersAlex Rossick-SolisBruce A. BuckinghamTali JacobsonMarissa TownIdeen TabatabaiJordan KellerEvalina SalasFrancis J. DoyleEyal DassauSamantha PassmanTiffany CamposCraig KollmanCarlos MurphyNandan PatibandlaSarah BorgmanGuillermo Arreaza-RubínNeal GreenStacey M. AndersonMarc D. BretonYogish C. KudvaR. Paul WadwaBruce A. BuckinghamFrancis J. DoyleÉric RenardClaudio CobelliYves ReznikGuillermo Arreaza-RubínRobert JanicekDeanna GabrielsonSteven H. BelleJessica R. CastleJennifer GreenLaurent LegaultSteven M. WilliCarol WyshamThomas L. Eggerman
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Background: Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Methods: Participants were randomized 2:1 to CLC (N = 112) versus SAP (N = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months. CLC participants also completed Diabetes Technology Expectations and Acceptance and System Usability Scale (SUS). Results: The Hypoglycemia Fear Survey Behavior subscale improved significantly after 6 months of CLC compared with SAP. DDS did not differ except for powerless subscale scores, which worsened at 3 months in SAP. Whereas Hypoglycemia Awareness and Hyperglycemia Avoidance did not differ between groups, CLC participants showed a tendency toward improved confidence in managing hypoglycemia. The INSPIRE questionnaire showed favorable scores in the CLC group for teens and parents, with a similar trend for adults. At baseline and 6 months, CLC participants had high positive expectations for the device with Diabetes Technology Acceptance and SUS showing high benefit and low burden scores. Conclusion: CLC improved some PROs compared with SAP. Participants reported high benefit and low burden with CLC. Clinical Trial Identifier: NCT03563313.Hypoglycemia is a condition characterized by an abnormally low level of blood glucose and has significant clinical consequences if left untreated. It is a potential adverse event in the treatment of diabetes mellitus. Causes of hypoglycemia are varied, but in diabetic patients, it is most often iatrogenic. Medication changes or overdoses, infection, dietary changes, and changes in activity levels are some of the important reasons for a person to develop hypoglycemia. Prompt diagnosis and treatment of hypoglycemia is an essential component of the management of diabetes. Evaluation of the cause is important, especially if there are recurrent episodes of hypoglycemia.
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Objective To evaluate the therapeutic effects of one visit root canal therapy(RCT) and several visit RCT for cracked teeth.Methods Cracked teeth with pulposis or apical disease were randomized to receive one visit RCTor several visit RCT,their responses were compared.Results The long-term therapeutic effects of one visit RCT were batter than those of several visit RCT,but the differences were not significant.The concomitant symptoms were significantly less and treatment time was significantly shorter in one visit RCT group as compared with several visit RCT group.Conclusion One visit RCT is recommended for the RCT of cracked teeth.
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無作為化比較試験（RCT, randomized controlled trial）が新しい治療法の効果を評価するためにヒトに施される実験であり，かつまた，それが最も質の高い科学的なエビデンスを提供してくれる唯一の研究デザインであることは世界的に広く認められた事実である．一方，日本では，RCT に対する関心とその重要性への認識は低く，薬効評価の分野でも質の高い RCT はきわめて少なかった．最近の科学的根拠に基づく医療（EBM）の流行により RCT に対する関心は高まっているものの，RCT を正しく理解して実践できる臨床医，製薬メーカの臨床開発担当者は少ない．このことは補完代替医療の評価においても全く同様にあてはまる．RCT を正しく理解し，デザインし，その結果を正しく評価できる研究者，実務家の養成は急務である．本小論では，RCT とは何か，RCT をデザインする上で必要不可欠な統計学的考え方を解説する．
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The fear of hypoglycemia in type 2 diabetes mellitus (T2DM) patients with hypoglycemia has seriously affected their quality of life. They are always afraid of hypoglycemia and often take excessive action to avoid it. Yet, researchers have investigated the relationship between hypoglycemia worries and excessive avoiding hypoglycemia behavior using total scores on self-report measures. However, network analysis studies of hypoglycemia worries and excessive avoiding hypoglycemia behavior in T2DM patients with hypoglycemia are lacking.The present study investigated the network structure of hypoglycemia worries and avoiding hypoglycemia behavior in T2DM patients with hypoglycemia and aimed to identify bridge items to help them correctly treat hypoglycemia and properly deal with hypoglycemia fear.A total of 283 T2DM patients with hypoglycemia were enrolled in our study. Hypoglycemia worries and avoiding hypoglycemia behavior were evaluated with the Hypoglycemia Fear Scale. Network analyses were used for the statistical analysis.B9 "Had to stay at home for fear of hypoglycemia" and W12 "I am worried that hypoglycemia will affect my judgment" have the highest expected influences in the present network. In the community of hypoglycemia worries, W17 "I worry about hypoglycemia during sleep" has the highest bridge expected influence. And in the community of avoiding hypoglycemia behavior, B9 "Had to stay at home for fear of hypoglycemia" has the highest bridge expected influence.Complex patterns of associations existed in the relationship between hypoglycemia worries and avoiding hypoglycemia behavior in T2DM patients with hypoglycemia. From the perspective of network analysis, B9 "Had to stay at home for fear of hypoglycemia" and W12 "I am worried that hypoglycemia will affect my judgment" have the highest expected influence, indicating their highest importance in the network. W17 "I worry about hypoglycemia during sleep" aspect of hypoglycemia worries and B9 "Had to stay at home for fear of hypoglycemia" aspect of avoiding hypoglycemia behavior have the highest bridge expected influence, indicating they have the strongest connections with each community. These results have important implications for clinical practice, which provided potential targets for interventions to reduce hypoglycemia fear and improve the quality of life in T2DM patients with hypoglycemia.
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Objective:To investigate the causes and preventive measures of critical patients' hypoglycemia.Methods:Using a methodology that is reviewing and analyzing the hypoglycemia of critical patients in our department in recent years.Results: The result shows that drug-induced hypoglycemia is more frequent than non-drug-induced hypoglycemia while asymptomatic hypoglycemia is more frequent than symptomatic hypoglycemia.it is important to implement the continuous glucose monitoring in critical patients.Conclusion:To discover and correct Hypoglycemia in time and avoid abnormal impact.
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This study investigated the association between diabetes complications, diabetes distress, and depressive symptoms in patients with type 2 diabetes mellitus. A total of 600 patients with type 2 diabetes mellitus were included in this study. Data were collected using the Diabetes Distress Scale and the nine-item Patient Health Questionnaire. The results showed that both diabetes complications and diabetes distress were positively associated with depressive symptoms, and diabetes distress attenuated the association between diabetes complications and depressive symptoms. The Sobel test confirmed the mediating effect of diabetes distress. Patients with both diabetes complications and diabetes distress had a higher risk of depressive symptoms than those with diabetes complications or diabetes distress alone. This study indicates that the positive association between diabetes complications and depressive symptoms is persistent and mediated by diabetes distress, and the comorbidity of diabetes complications and diabetes distress has an additive interaction effect on depressive symptoms.
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From the aspect of social and demographic factors, disease-related factors, social support, coping style and other factors outlined in diabetic patients with diabetes distress, and diabetes theoretical development and current situation of diabetes distress interventions were reviewed, in order to implement targeted interventions for diabetes patients.
Key words:
Diabetes mellitus; Review; Diabetes distress
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