35 results on '"Laugesen, C."'
Search Results
2. Attendance in a national screening program for diabetic retinopathy:a population-based study of 205,970 patients
- Author
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Thykjær, Anne Suhr, Andersen, N., Bek, T., Heegaard, S., Hajari, J., Laugesen, C. S., Möller, S., Pedersen, F. N., Rosengaard, L., Schielke, K. C., Kawasaki, R., Højlund, K., Rubin, K. H., Stokholm, L., Grauslund, J., Thykjær, Anne Suhr, Andersen, N., Bek, T., Heegaard, S., Hajari, J., Laugesen, C. S., Möller, S., Pedersen, F. N., Rosengaard, L., Schielke, K. C., Kawasaki, R., Højlund, K., Rubin, K. H., Stokholm, L., and Grauslund, J.
- Abstract
Aims: A nationwide diabetic retinopathy (DR) screening program has been established in Denmark since 2013. We aimed to perform an evaluation of adherence to DR screenings and to examine whether non-adherence was correlated to DR progression. Methods: The population consisted of a register-based cohort, who participated in the screening program from 2013 to 2018. We analyzed age, gender, marital status, DR level (International Clinical DR severity scale, none, mild-, moderate-, severe non-proliferative DR (NPDR) and proliferative DR (PDR)), comorbidities and socioeconomic factors. The attendance pattern of patients was grouped as either timely (no delays > 33%), delayed (delays > 33%) or one-time attendance (unexplained). Results: We included 205,970 patients with 591,136 screenings. Rates of timely, delayed and one-time attendance were 53.0%, 35.5% and 11.5%, respectively. DR level at baseline was associated with delays (mild-, moderate-, severe NPDR and PDR) and one-time attendance (moderate-, severe NPDR and PDR) with relative risk ratios (RRR) of 1.68, 2.27, 3.14, 2.44 and 1.18, 2.07, 1.26, respectively (P < 0.05). Delays at previous screenings were associated with progression to severe NPDR or PDR (hazard ratio (HR) 2.27, 6.25 and 12.84 for 1, 2 and 3+ delays, respectively). Any given delay doubled the risk of progression (HR 2.28). Conclusions: In a national cohort of 205,970 patients, almost half of the patients attended DR screening later than scheduled or dropped out after first screening episode. This was, in particular, true for patients with any levels of DR at baseline. DR progression in patients with delayed attendance, increased with the number of missed appointments.
- Published
- 2022
3. CGM chez des patients DT2 insulinotraités switchés pour l’insuline icodec hebdomadaire vs comparateurs journaliers : post-hoc des études ONWARDS 2 et 4
- Author
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Zummo, F., Ásbjörnsdóttir, B., Bajaj, H.S., Laugesen, C., Mathieu, C., Philis-Tsimikas, A., Wang, N., and Battelino, T.
- Abstract
Le temps passé dans, au-dessus et en dessous de la cible (TIR, TAR, TBR) de deux essais de phase 3 sur des patients DT2 sous insuline, randomisés à l’insuline hebdomadaire icodec a été étudié.
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- 2024
- Full Text
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4. Smartphone data offer insights into disease activity and triggers in atopic dermatitis:a fully decentralized remote longitudinal pilot study
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Eiken, A., Laugesen, C. P., Isberg, A., Thomsen, S. F., Ali, Z., Chiriac, A., Dutei, A. M., Deaconescu, I., Manole, I., Valk, T. J., Andersen, A. D., Zibert, J. R., Eiken, A., Laugesen, C. P., Isberg, A., Thomsen, S. F., Ali, Z., Chiriac, A., Dutei, A. M., Deaconescu, I., Manole, I., Valk, T. J., Andersen, A. D., and Zibert, J. R.
- Published
- 2021
5. Progression of diabetic retinopathy during pregnancy in women with type 2 diabetes
- Author
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Rasmussen, K. L., Laugesen, C. S., Ringholm, L., Vestgaard, M., Damm, P., and Mathiesen, E. R.
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- 2010
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6. Durée d’hypoglycémie similaire avec icodec vs degludec ou glargine U100 chez les patients DT2 insulinotraités : analyse CGM post-hoc d’ONWARDS 2 et 4
- Author
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Zummo, F., Battelino, T., Ásbjörnsdóttir, B., Carstensen, L., Laugesen, C., Mathieu, C., Philis-Tsimikas, A., and Bajaj, H.S.
- Abstract
icodec est une insuline basale hebdomaire qui a été étudiée dans le cadre du programme ONWARDS. Le temps passé en hypoglycémie pendant les périodes de switch (S0-4) et d’état d’équilibre (S22-26) de deux essais de phase 3 sur des patients DT2 sous insuline a été étudié.
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- 2024
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7. Pregnancy-induced sight-threatening diabetic retinopathy in women with Type 1 diabetes
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Vestgaard, M., Ringholm, L., Laugesen, C. S., Rasmussen, K. L., Damm, P., and Mathiesen, E. R.
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- 2010
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8. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration Chroma and Spectri Phase 3 Randomized Clinical Trials
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Holz, Fg, Sadda, Sr, Busbee, B, Chew, Ey, Mitchell, P, Tufail, A, Brittain, C, Ferrara, D, Gray, S, Honigberg, L, Martin, J, Tong, B, Ehrlich, Js, Bressler, Nm, Sola, Ff, Schlottmann, P, Zambrano, A, Zeolite, C, Arnold, J, Gillies, M, Luckie, A, Schneltzer, N, de Zaeytijd, J, Boyd, S, Cruess, A, Kertes, P, Lalonde, L, Maberley, D, Laugesen, C, Bodaghi, B, Cohen, Sy, Francais, C, Souied, E, Tadayoni, R, Altay, L, Eter, N, Feltgen, N, Framme, C, Grisanti, S, Holz, F, Pauleikhoff, D, Seres, A, Vajas, A, Varsanyi, B, Boscia, F, Parravano, Mc, Ricci, F, Viola, F, Rechy, Dl, Morales, V, Dijkman, G, Schlingemann, R, Reategui, G, Raczynska, D, Romanowska-Dixon, B, Teper, S, Kacerik, M, Lipkova, B, Oddelenie, O, Mikova, H, Araiz, J, Arias, L, Mataix, J, Mones, J, Montero, J, Sararols, L, Michels, S, Brand, C, Dhillon, B, Agarwal, A, Alfaro, V, Baker, B, Berger, B, Bhisitkul, R, Blodi, B, Boyer, D, Brooks, Hl, Burgess, S, Busquets, M, Callanan, D, Chan, C, Chang, J, Chen, S, Combs, J, Dhoot, D, Dugel, P, Eichenbaum, D, Feist, R, Ferrone, P, Fine, H, Fortun, J, Fox, Ga, Fu, A, Gentile, R, Ghorayeb, G, Gill, M, Gonzalez, V, Gordon, C, Gupta, S, Hampton, R, Heier, J, Hershberger, V, Higgins, P, Ie, D, Isernhagen, R, Katz, R, Kokame, G, Kwun, R, Lee, P, Lee, S, Mansour, S, Marcus, D, Maturi, R, Michels, M, Moore, J, Nielsen, J, Novalis, G, Ober, M, Olsen, K, Patel, S, Pieramici, D, Raskauskas, P, Rofagha, S, Ruby, A, Schneiderman, T, Schwartz, S, Shah, R, Sheth, V, Singerman, L, Singh, R, Sjaarda, R, Stoller, G, Stoltz, R, Suner, I, Tabassian, A, Tarantola, R, Thach, A, Ufret-Vincenty, R, Wirthlin, R, Witkin, A, Wong, R, Wood, M, Zheutlin, J, Alezzandrini, A, Cartier, Mm, Chauhan, D, Chen, F, Gilhotra, J, Guymer, R, Kwan, A, Schmidt-Erfurth, U, Jacob, J, Postelmans, L, Larsen, M, Garcher, Cc, Bocage, C, Devin, F, Kodjikian, L, Korobelnik, Jf, Said, Sm, Weber, M, Agostini, H, Auffarth, G, Bartz-Schmidt, U, Bell, K, Gamulescu, A, Hattenbach, L, Lohmann, Cp, Wolf, A, Nemeth, J, Vamosi, P, Bandello, F, Eandi, C, Lanzetta, P, Nicolo, M, Staurenghi, G, Virgili, G, Franco, Rg, Estudillo, Jr, Hoyng, C, Fernandez, C, Guzman, M, Lujan, S, Herba, E, Kaluzny, J, Misiuk-Hojlo, M, Nawrocki, J, Carneiro, A, Figueira, J, Silva, R, Vaz-Pereira, S, Abdulaeva, E, Erichev, V, Zolotarev, A, Cernak, A, Figueroa, M, Gallego-Pinazo, R, Garcia-Layana, A, Ulla, Fg, Navarro, R, Ortiz, Jm, Imaz, Rt, Kvanta, A, Hatz, K, Wolf, S, Eldem, B, Kir, N, Mentes, J, Saatci, O, Yilmaz, G, Bailey, C, Banerjee, S, Browning, A, Esposti, S, Gale, R, Ghanchi, F, Jackson, T, Lotery, A, Mahmood, S, Mohamed, Q, Narendran, N, Pearce, I, Williams, M, Abraham, P, Abrams, G, Adrean, S, Antoszyk, A, Baker, C, Breazeale, R, Bridges, Wz, Brown, Dm, Calzada, J, Campochiaro, P, Chaudhry, N, Clark, L, Connolly, B, Csaky, K, Do, D, Dreyer, R, Durant, W, Eaton, A, Feiner, L, Ferreyra, H, Flaxel, C, Foxman, S, Freund, Kb, Gonzales, Cr, Gordon, A, Halperin, L, Ho, A, Holekamp, N, Husain, D, Jain, N, Javid, C, Johnson, M, Kiss, S, Lad, E, Leng, T, Liu, M, London, N, Madow, B, Miller, D, Morse, L, Ohr, M, Oliver, S, Pearlman, J, Ray, Sk, Regillo, C, Rosa, R, Rosenfeld, P, Saperstein, D, Sarraf, D, Shildkrot, Y, Suan, E, Weishaar, P, Wieland, M, Williams, D, Williams, J, Wykoff, Cc, Ophthalmology, ACS - Atherosclerosis & ischemic syndromes, ANS - Cellular & Molecular Mechanisms, and ANS - Systems & Network Neuroscience
- Subjects
Male ,0301 basic medicine ,medicine.medical_specialty ,Visual acuity ,Population ,Visual Acuity ,Urology ,law.invention ,Lesion ,Immunoglobulin Fab Fragments ,Macular Degeneration ,03 medical and health sciences ,0302 clinical medicine ,Atrophy ,Double-Blind Method ,Randomized controlled trial ,law ,Settore MED/30 ,Geographic Atrophy ,80 and over ,medicine ,Humans ,Prospective Studies ,Fluorescein Angiography ,Prospective cohort study ,education ,Aged ,Original Investigation ,Aged, 80 and over ,education.field_of_study ,business.industry ,Middle Aged ,Macular degeneration ,Complement Factor D ,Female ,Intravitreal Injections ,Treatment Outcome ,medicine.disease ,Clinical trial ,Ophthalmology ,030104 developmental biology ,030221 ophthalmology & optometry ,medicine.symptom ,business - Abstract
Importance Geographic atrophy (GA) secondary to age-related macular degeneration is a leading cause of visual disability in older individuals. A phase 2 trial suggested that lampalizumab, a selective complement factor D inhibitor, reduced the rate of GA enlargement, warranting phase 3 trials. Objective To assess the safety and efficacy of lampalizumab vs sham procedure on enlargement of GA. Design, Setting, and Participants Two identically designed phase 3 double-masked, randomized, sham-controlled clinical trials, Chroma and Spectri, enrolled participants from August 28, 2014, to October 6, 2016, at 275 sites in 23 countries. Participants were aged 50 years or older, with bilateral GA and no prior or active choroidal neovascularization in either eye and GA lesions in the study eye measuring 2.54 to 17.78 mm 2 with diffuse or banded fundus autofluorescence patterns. Interventions Participants were randomized 2:1:2:1 to receive 10 mg of intravitreous lampalizumab every 4 weeks, sham procedure every 4 weeks, 10 mg of lampalizumab every 6 weeks, or sham procedure every 6 weeks, through 96 weeks. Main Outcomes and Measures Safety and efficacy assessed as mean change from baseline in GA lesion area at week 48 from centrally read fundus autofluorescence images of the lampalizumab arms vs pooled sham arms, in the intent-to-treat population and by complement factor I–profile genetic biomarker. Results A total of 906 participants (553 women and 353 men; mean [SD] age, 78.1 [8.1] years) were enrolled in Chroma and 975 participants (578 women and 397 men; mean [SD] age, 77.9 [8.1] years) were enrolled in Spectri; 1733 of the 1881 participants (92.1%) completed the studies through 48 weeks. The adjusted mean increases in GA lesion area from baseline at week 48 were 1.93 to 2.09 mm 2 across all groups in both studies. Differences in adjusted mean change in GA lesion area (lampalizumab minus sham) were −0.02 mm 2 (95% CI, −0.21 to 0.16 mm 2 ; P = .80) for lampalizumab every 4 weeks in Chroma, 0.16 mm 2 (95% CI, 0.00-0.31 mm 2 ; P = .048) for lampalizumab every 4 weeks in Spectri, 0.05 mm 2 (95% CI, −0.13 to 0.24 mm 2 ; P = .59) for lampalizumab every 6 weeks in Chroma, and 0.09 mm 2 (95% CI, −0.07 to 0.24 mm 2 ; P = .27) for lampalizumab every 6 weeks in Spectri. No benefit of lampalizumab was observed across prespecified subgroups, including by complement factor I–profile biomarker. Endophthalmitis occurred after 5 of 12 447 injections (0.04%) or in 5 of 1252 treated participants (0.4%) through week 48. Conclusions and Relevance In Chroma and Spectri, the largest studies of GA conducted to date, lampalizumab did not reduce GA enlargement vs sham during 48 weeks of treatment. Results highlight the substantial and consistent enlargement of GA, at a mean of approximately 2 mm 2 per year. Trial Registration ClinicalTrials.gov Identifier:NCT02247479andNCT02247531
- Published
- 2018
9. Rössler Bands in Economic and Biological Systems
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Hald, B. G., Laugesen, C. N., Nielsen, C., Mosekilde, E., Larsen, E. R., Engelbrecht, J., Milling, Peter M., editor, and Zahn, Erich O. K., editor
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- 1989
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10. Corporate Reputation as a strategic Performance Measure
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Jacob Eskildsen, Kai Kristensen, Vestergaard, T., Schmidt-Laugesen, C., and Neely, Kennerly and Walters, null
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- 2004
11. Pharmacokinetics of intravitreal 5-fluorouracil prodrugs in silicone oil: experimental studies in pigs
- Author
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Laugesen, C., Steffansen, B., Scherfig, E., Cour, M. l., Laugesen, C., Steffansen, B., Scherfig, E., and Cour, M. l.
- Abstract
ophthalmology, -Fluorouracil, prodrugs, controlled release, ocular drug delivery, proliferative vitreoretinopathy
- Published
- 2005
12. Pregnancy-induced sight-threatening diabetic retinopathy in women with type 1 diabetes
- Author
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Vestgaard, M., primary, Ringholm, L., additional, Laugesen, C. S., additional, Rasmussen, K. L., additional, Damm, P., additional, and Mathiesen, E. R., additional
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- 2009
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13. 269 Cystic Fibrosis related diabetes: the presence of microvascular diabetic complications
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Andersen, H.U., primary, Lanng, S., additional, Pressler, T., additional, Laugesen, C., additional, and Mathiesen, E., additional
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- 2006
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14. Wastewater treatment in tsunami affected areas of Thailand by constructed wetlands.
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Brix, H., Koottatep, T., and Laugesen, C. H.
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TSUNAMI damage ,CONSTRUCTED wetlands ,WASTEWATER treatment ,DRAINAGE ,HYDRAULIC engineering ,SANITARY engineering ,SEPTIC tanks ,RURAL sewage disposal ,RED Cross & Red Crescent - Abstract
The tsunami of December 2004 destroyed infrastructure in many coastal areas in South-East Asia. In January 2005, the Danish Government gave a tsunami relief grant to Thailand to re-establish the wastewater management services in some of the areas affected by the tsunami. This paper describes the systems which have been built at three locations: (a) Baan Pru Teau: A newly-built township for tsunami victims which was constructed with the contribution of the Thai Red Cross. Conventional septic tanks were installed for the treatment of blackwater from each household and its effluent and grey water (40m³/day) are collected and treated at a 220m² subsurface flow constructed wetland. (b) Koh Phi Phi Don island: A wastewater collection system for the main business and hotel area of the island, a pumping station and a pressure pipe to the treatment facility, a multi-stage constructed wetland system and a system for reuse of treated wastewater. The constructed wetland system (capacity 400m³/day) consists of vertical flow, horizontal subsurface flow, free water surface flow and pond units. Because the treatment plant is surrounded by resorts, restaurants and shops, the constructed wetland systems are designed with terrains as scenic landscaping. (c) Patong: A 5,000m² constructed wetland system has been established to treat polluted water from drainage canals which collect overflow from septic tanks and grey water from residential areas. It is envisaged that these three systems will serve as prototype demonstration systems for appropriate wastewater management in Thailand and other tropical countries. [ABSTRACT FROM AUTHOR]
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- 2007
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15. Individualised screening for diabetic retinopathy with proliferative retinopathy and macular oedema as separate end points.
- Author
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Bek T, Andersen N, Andresen J, Grauslund J, Hajari J, Schmidt Laugesen C, Schielke K, and Petersen L
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- Humans, Male, Female, Middle Aged, Risk Factors, Aged, Adult, Diabetic Retinopathy diagnosis, Macular Edema diagnosis, Macular Edema etiology, Algorithms, Mass Screening methods
- Abstract
Purpose: A number of algorithms have been developed to calculate screening intervals for diabetic retinopathy on the basis of individual risk factors. However, these approaches have not considered proliferative diabetic retinopathy (PDR) and diabetic macular oedema (DME) as separate end points and death as competing risk., Methods: A multi-state survival model with death as competing risk was used to predict the screening interval for diabetic retinopathy based on information about all 2446 patients from a well-defined population who had started treatment for either PDR or DME during 25 years. The performance of the model was tested on the existing database and at seven screening sites on patients who had not developed a treatment requiring condition., Results: Testing on the existing database showed that at a risk level of 2% the algorithm could predict a screening interval with a success rate higher than 90% and a 1.75 times average prolongation of the screening interval without failing to detect the development of verified PDR og DME. The model was limited to a diabetes duration shorter than 40 years and depended on knowledge of relevant risk factors. At the other participating screening sites the algorithm predicted shorter intervals than the screener., Conclusions: Algorithms for individualised screening for diabetic retinopathy can prolong screening intervals without losing patients who develop a vision threatening condition. The calculation of screening intervals requires access to relevant risk factors and should be developed on large data sets that reflect the population in which the algorithm should be used., (© 2024 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)
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- 2024
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16. Frequency of Rebound Hyperglycemia in Adults with Type 1 Diabetes Treated with Different Insulin Delivery Modalities.
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Tidemand KG, Laugesen C, Ranjan AG, Skovhus LB, and Nørgaard K
- Abstract
Background: For people with type 1 diabetes (T1D), ensuring fast and effective recovery from hypoglycemia while avoiding posthypoglycemic hyperglycemia (rebound hyperglycemia, RH) can be challenging. The objective of this study was to investigate the frequency of RH across different treatment modalities and its impact on glycemic control. Methods: This cross-sectional real-world study included adults with T1D using continuous glucose monitoring and attending the outpatient clinic at Steno Diabetes Center Copenhagen. RH was defined as ≥1 sensor glucose value (SG) >10.0 mmol/L (180 mg/dL) starting within 2 h of an antecedent SG <3.9 mmol/L (70 mg/dL). The severity of the RH events was calculated as area under the curve (AUC) and separately for users of multiple daily injections (MDIs), unintegrated insulin pumps, sensor augmented pumps (SAPs), and automated insulin delivery (AID), respectively. Results: Across the four groups, SAP and AID users had the highest incidence of RH (2.06 ± 1.65 and 2.08 ± 1.49 events per week, respectively) and a similar percentage of hypoglycemic events leading to RH events (41.3 ± 22.8% and 39.6 ± 20.1%, respectively). The AID users with RH events were significantly shorter compared with MDI users (122 ± 72 vs. 185 ± 135 min; P < 0.0001). Overall, severity of RH was inversely associated with more advanced technology ( P < 0.001) and inversely associated ( P < 0.001) with time in target range (TIR). Conclusions: Groups with insulin suspension features experienced the highest frequency of RH; however, AID users tended to experience shorter and less severe RH events. The association between the severity of RH events and TIR suggests that RH should be assessed and used in the guidance of hypoglycemia management.
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- 2024
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17. Impact of Missed and Late Meal Boluses on Glycemic Outcomes in Automated Insulin Delivery-Treated Children and Adolescents with Type 1 Diabetes: A Two-Center, Population-Based Cohort Study.
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Laugesen C, Ritschel T, Ranjan AG, Hsu L, Jørgensen JB, Svensson J, Ekhlaspour L, Buckingham B, and Nørgaard K
- Abstract
Objective: To evaluate the impact of missed or late meal boluses (MLBs) on glycemic outcomes in children and adolescents with type 1 diabetes using automated insulin delivery (AID) systems. Research Design and Methods: AID-treated (Tandem Control-IQ or Medtronic MiniMed 780G) children and adolescents (aged 6-21 years) from Stanford Medical Center and Steno Diabetes Center Copenhagen with ≥10 days of data were included in this two-center, binational, population-based, retrospective, 1-month cohort study. The primary outcome was the association between the number of algorithm-detected MLBs and time in target glucose range (TIR; 70-180 mg/dL). Results: The study included 189 children and adolescents (48% females with a mean ± standard deviation age of 13 ± 4 years). Overall, the mean number of MLBs per day in the cohort was 2.2 ± 0.9. For each additional MLB per day, TIR decreased by 9.7% points (95% confidence interval [CI] 11.3; 8.1), and compared with the quartile with fewest MLBs (Q
1 ), the quartile with most (Q4 ) had 22.9% less TIR (95% CI: 27.2; 18.6). The age-, sex-, and treatment modality-adjusted probability of achieving a TIR of >70% in Q4 was 1.4% compared with 74.8% in Q1 ( P < 0.001). Conclusions: MLBs significantly impacted glycemic outcomes in AID-treated children and adolescents. The results emphasize the importance of maintaining a focus on bolus behavior to achieve a higher TIR and support the need for further research in technological or behavioral support tools to handle MLBs.- Published
- 2024
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18. Real-world experiences with intravitreal treatment with ranibizumab and aflibercept for diabetic macular oedema 2008-2021.
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Lindboe JB, Brynskov T, Sørensen TL, and Schmidt Laugesen C
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- Humans, Male, Female, Tomography, Optical Coherence methods, Vascular Endothelial Growth Factor A antagonists & inhibitors, Retrospective Studies, Aged, Middle Aged, Treatment Outcome, Receptors, Vascular Endothelial Growth Factor administration & dosage, Receptors, Vascular Endothelial Growth Factor therapeutic use, Ranibizumab administration & dosage, Intravitreal Injections, Diabetic Retinopathy drug therapy, Diabetic Retinopathy diagnosis, Macular Edema drug therapy, Macular Edema diagnosis, Recombinant Fusion Proteins administration & dosage, Recombinant Fusion Proteins therapeutic use, Angiogenesis Inhibitors administration & dosage, Angiogenesis Inhibitors therapeutic use, Visual Acuity
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- 2024
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19. Continuous Glucose Monitoring-Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-standing Type 2 Diabetes Switched From a Daily Basal Insulin to Once-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4.
- Author
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Bajaj HS, Ásbjörnsdóttir B, Carstensen L, Laugesen C, Mathieu C, Philis-Tsimikas A, and Battelino T
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- Humans, Insulin therapeutic use, Hypoglycemic Agents therapeutic use, Blood Glucose, Blood Glucose Self-Monitoring, Continuous Glucose Monitoring, Insulin Glargine therapeutic use, Insulin, Regular, Human, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemia, Insulin, Long-Acting
- Abstract
Objective: This post hoc analysis assessed continuous glucose monitoring (CGM)-based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4)., Research Design and Methods: Time in range (TIR) (3.9-10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), and time below range (TBR) (<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0-4], end of treatment [weeks 22-26], and follow-up [weeks 27-31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed., Results: In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end-of-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min)., Conclusions: In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets., (© 2024 by the American Diabetes Association.)
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- 2024
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20. Factory-Calibrated Continuous Glucose Monitoring Systems in Type 1 Diabetes: Accuracy during In-Clinic Exercise and Home Use.
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Lundemose SB, Laugesen C, Ranjan AG, and Nørgaard K
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- Adult, Humans, Blood Glucose, Blood Glucose Self-Monitoring, Calibration, Exercise, Reproducibility of Results, Diabetes Mellitus, Type 1
- Abstract
Continuous glucose monitors (CGMs) are valuable tools for improving glycemic control, yet their accuracy might be influenced by physical activity. This study sought to assess the accuracy of the three latest factory-calibrated CGM systems available in Europe at the time the study was conducted, both during aerobic exercise and in typical daily scenarios. The accuracy evaluation, based on metrics such as the median absolute relative difference (MARD) and point and rate error-grid analyses (PEGA and REGA), involved 13 adults with type 1 diabetes. Participants wore all sensors during a 1 h in-clinic exercise session followed by a subsequent 3-day home period, with blood glucose measurements serving as reference values in both contexts. During exercise, no statistically significant differences in MARD were observed (Dexcom G6: 12.6%, Guardian 4: 10.7%, and Freestyle Libre 2: 17.2%; p = 0.31), and similarly, no significant differences emerged in PEGA-zone-AB (100%, 100%, 96.8%; p = 0.37). Nevertheless, Freestyle Libre 2 showed comparatively diminished accuracy in estimating glucose trends during exercise (REGA-zone-AB: 100%, 93.0%, 73.3%; p = 0.0003). In the home environment, Freestyle Libre 2 exhibited a significantly higher MARD when compared to the other systems (10.2%, 11.9%, 16.7%, p = 0.02). Overall, Dexcom G6 and Guardian 4 demonstrated superior accuracy in both exercise and daily life scenarios compared to Freestyle Libre 2.
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- 2023
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21. Inter-grader reliability in the Danish screening programme for diabetic retinopathy.
- Author
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Thykjaer AS, Andresen J, Andersen N, Bek T, Heegaard S, Hajari J, Schmidt Laugesen C, Möller S, Pedersen FN, Kawasaki R, Højlund K, Rubin KH, Stokholm L, Peto T, and Grauslund J
- Subjects
- Humans, Reproducibility of Results, Photography methods, Mass Screening methods, Denmark epidemiology, Diabetic Retinopathy diagnosis, Diabetic Retinopathy epidemiology, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 diagnosis
- Abstract
Purpose: The Danish Registry of Diabetic Retinopathy includes information from >200 000 patients who attends diabetic retinopathy (DR) screening in Denmark. Screening of patients with uncomplicated type 2 diabetes is often performed by practicing ophthalmologists, while patients with type 1 and complicated type 2 diabetes attends screening at hospitals. We performed a clinical reliability study of retinal images from Danish screening facilities to explore the inter-grader agreement between the primary screening ophthalmologist and a blinded, certified grader., Methods: Invitations to participate were sent to screening facilities across Denmark. The primary grader uploaded fundus photographs with information on estimated level of DR (International Clinical Diabetic Retinopathy scale as 0 [no DR], 1-3 [mild, moderate or severe nonproliferative DR {NPDR}], or 4 [proliferative DR {PDR}]), region of screening, image style, and screening facility. Images were then regraded by a blinded, certified, secondary grader. Weighted kappa analysis was performed to evaluate agreement., Results: Fundus photographs from 230 patients (458 eyes) were received from practicing ophthalmologists (52.6%) and hospital-based grading centres (47.4%) from all Danish regions. Reported levels of DR by the primary graders were 66.8%, 12.2%, 13.1%, 1.3% and 5.5% for DR levels 0-4. The overall agreement between primary and secondary graders was 93% (κ = 0.83). Based on screening facility agreement was 96% (κ = 0.89) and 90% (κ = 0.76) for practicing ophthalmologists and hospital-based graders., Conclusion: In this nationwide study, we observed a high overall inter-grader agreement and based on this, it is reasonable to assume that reported DR gradings in the screening programme in Denmark, accurately reflect the truth., (© 2023 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)
- Published
- 2023
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22. Glucose Monitoring Metrics in Individuals With Type 1 Diabetes Using Different Treatment Modalities: A Real-World Observational Study.
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Nørgaard K, Ranjan AG, Laugesen C, Tidemand KG, Green A, Selmer C, Svensson J, Andersen HU, Vistisen D, and Carstensen B
- Subjects
- Humans, Hypoglycemic Agents therapeutic use, Blood Glucose Self-Monitoring, Blood Glucose, Cross-Sectional Studies, Insulin therapeutic use, Insulin Infusion Systems, Insulin, Regular, Human therapeutic use, Diabetes Mellitus, Type 1 drug therapy
- Abstract
Objective: This study aimed to investigate the association between continuous glucose monitoring (CGM)-derived glycemic metrics and different insulin treatment modalities using real-world data., Research Design and Methods: A cross-sectional study at Steno Diabetes Center Copenhagen, Denmark, included individuals with type 1 diabetes using CGM. Data from September 2021 to August 2022 were analyzed if CGM was used for at least 20% of a 4-week period. Individuals were divided into four groups: multiple daily injection (MDI) therapy, insulin pumps with unintegrated CGM (SUP), sensor-augmented pumps with low glucose management (SAP), and automated insulin delivery (AID). The MDI and SUP groups were further subdivided based on CGM alarm features. The primary outcome was percentage of time in range (TIR: 3.9-10.0 mmol/L) for each treatment group. Secondary outcomes included other glucose metrics and HbA1c., Results: Out of 6,314 attendees, 3,184 CGM users were included in the analysis. Among them, 1,622 used MDI, 504 used SUP, 354 used SAP, and 561 used AID. Median TIR was 54.0% for MDI, 54.9% for SUP, 62,9% for SAP, and 72,1% for AID users. The proportion of individuals achieving all recommended glycemic targets (TIR >70%, time above range <25%, and time below range <4%) was significantly higher in SAP (odds ratio [OR] 2.4 [95% CI 1.6-3.5]) and AID (OR 9.4 [95% CI 6.7-13.0]) compared with MDI without alarm features., Conclusions: AID appears superior to other insulin treatment modalities with CGM. Although bias may be present because of indications, AID should be considered the preferred choice for insulin pump therapy., (© 2023 by the American Diabetes Association.)
- Published
- 2023
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23. Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial.
- Author
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Laugesen C, Ranjan AG, Schmidt S, and Nørgaard K
- Subjects
- Adult, Humans, Cross-Over Studies, Hypoglycemic Agents adverse effects, Blood Glucose Self-Monitoring, Blood Glucose, Insulin, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia drug therapy, Hypoglycemia prevention & control, Hypoglycemia chemically induced
- Abstract
Aims/hypothesis: Consumption of excess carbohydrates to manage hypoglycaemia can lead to rebound hyperglycaemia and promote weight gain. The objective of this trial was to evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions., Methods: Twenty-four adults with insulin pump-treated type 1 diabetes (HbA
1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods. During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively. Glycaemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event registration of prevention and treatment episodes., Results: Compared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively. In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3). Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect. Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia., Conclusions/interpretation: Use of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction., Trial Registration: ClinicalTrials.gov NCT04764968 FUNDING: The study was an investigator-initiated trial. Zealand Pharma supplied the investigational drug and device and provided financial support for the conduct of the trial., (© 2023. The Author(s).)- Published
- 2023
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24. Diabetic retinopathy is a predictor of chronic respiratory failure: A nationwide register-based cohort study.
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Thinggaard BS, Stokholm L, Davidsen JR, Larsen MC, Möller S, Thykjær AS, Andresen JL, Andersen N, Heegaard S, Højlund K, Kawasaki R, Laugesen C, Bek T, and Grauslund J
- Abstract
Purpose: Diabetic retinopathy (DR) is a hypoxic retinal disease, but so far, the association with systemic hypoxia is poorly understood. Hence, the aim of this study was to evaluate cross-sectional and longitudinal associations between DR and chronic respiratory failure (CRF) in a national cohort., Design: Cross-sectional and 5-year longitudinal register-based cohort study., Methods: Between 2013 and 2018, we included patients with diabetes from the Danish Registry of Diabetic Retinopathy, who were each age and sex matched with five controls without diabetes. At index date, the prevalence of CRF was compared between cases and controls, and the longitudinal relationship between DR and CRF was assessed in a five-year follow-up., Results: At baseline, we identified 1,980 and 9,990 patients with CRF among 205,970 cases and 1,003,170 controls. The prevalence of CRF was higher among cases than controls (OR 1.75, 95% CI 1.65-1.86), but no difference between cases with and without DR was found.During follow-up, we identified 1,726 and 5,177 events of CRF among cases and controls, respectively. The incidence of CRF was higher among both cases with and without DR compared to controls (DR level 0: HR 1.24, 95% CI 1.16-1.33, DR level 1-4: HR 1.86, 95% CI 1.63-2.12), and higher among cases with DR compared to cases without DR (HR 1.54, 95% CI 1.38-1.72)., Conclusion: In this study based on nationwide data, we found an increased risk of present and incident CRF in patients with diabetes with or without DR, and we identified DR as a predictor of future CRF., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors. Published by Elsevier Ltd.)
- Published
- 2023
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25. Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial.
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Lindkvist EB, Laugesen C, Reenberg AT, Ritschel TKS, Svensson J, Jørgensen JB, Nørgaard K, and Ranjan AG
- Subjects
- Adolescent, Humans, Male, Blood Glucose metabolism, Cross-Over Studies, Glucose, Single-Blind Method, Female, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 1 metabolism, Insulin
- Abstract
Objective: To assess the efficacy and safety of a dual-hormone (DH [insulin and glucagon]) closed-loop system compared to a single-hormone (SH [insulin only]) closed-loop system in adolescents with type 1 diabetes., Methods: This was a 26-hour, two-period, randomized, crossover, inpatient study involving 11 adolescents with type 1 diabetes (nine males [82%], mean ± SD age 14.8 ± 1.4 years, diabetes duration 5.7 ± 2.3 years). Except for the treatment configuration of the DiaCon Artificial Pancreas: DH or SH, experimental visits were identical consisting of: an overnight stay (10:00 pm until 7:30 am), several meals/snacks, and a 45-minute bout of moderate intensity continuous exercise. The primary endpoint was percentage of time spent with sensor glucose values below range (TBR [<3.9 mmol/L]) during closed-loop control over the 26-h period (5:00 pm, day 1 to 7:00 pm, day 2)., Results: Overall, there were no differences between DH and SH for the following glycemic outcomes (median [IQR]): TBR 1.6 [0.0, 2.4] vs. 1.28 [0.16, 3.19]%, p=1.00; time in range (TIR [3.9-10.0 mmol/L]) 68.4 [48.7, 76.8] vs. 75.7 [69.8, 87.1]%, p=0.08; and time above range (TAR [>10.0 mmol/L]) 28.1 [18.1, 49.8] vs. 23.3 [12.3, 27.2]%, p=0.10. Mean ( ± SD) glucose was higher during DH than SH (8.7 ( ± 3.2) vs. 8.1 ( ± 3.0) mmol/L, p<0.001) but coefficient of variation was similar (34.8 ( ± 6.8) vs. 37.3 ( ± 8.6)%, p=0.20). The average amount of rescue carbohydrates was similar between DH and SH (6.8 ( ± 12.3) vs. 9.5 ( ± 15.4) grams/participant/visit, p=0.78). Overnight, TIR was higher, TAR was lower during the SH visit compared to DH. During and after exercise (4:30 pm until 7 pm) the SH configuration produced higher TIR, but similar TAR and TBR compared to the DH configuration., Conclusions: DH and SH performed similarly in adolescents with type 1 diabetes during a 26-hour inpatient monitoring period involving several metabolic challenges including feeding and exercise. However, during the night and around exercise, the SH configuration outperformed DH., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Lindkvist, Laugesen, Reenberg, Ritschel, Svensson, Jørgensen, Nørgaard and Ranjan.)
- Published
- 2023
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26. The Copenhagen Actinic Keratosis Study (COAKS). A decentralised clinical trial to evaluate tolerability, safety and efficacy of daily field-directed topical treatment with cytosolic phospholipase A 2 inhibitor, AVX001, in participants with actinic keratosis: protocol for a randomised controlled phase I/IIa trial.
- Author
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Ortner VK, Johansen B, Kilov K, Castillo Mondragón A, Duvold T, Kihl J, Ashcroft FJ, Feuerherm AJ, Pind Laugesen C, Marcker Espersen ML, Manole I, Isberg AP, Andersen AD, Rakvaag E, Zibert JR, and Haedersdal M
- Subjects
- Adult, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Humans, Randomized Controlled Trials as Topic, Treatment Outcome, Fatty Acids, Omega-3 adverse effects, Keratosis, Actinic drug therapy, Phospholipase A2 Inhibitors adverse effects
- Abstract
Introduction: Actinic keratosis (AK) is the most common precancerous skin condition caused by long-term UV exposure. Given the high recurrence rate of 15%-53%, identifying safe and effective treatment options is warranted. AVX001, a cytosolic phospholipase A
2 α (cPLA2 α) enzyme inhibitor, is a novel anti-inflammatory drug for field-directed, self-administered, topical therapy of AK., Methods and Analysis: This study is a single-centre, randomised, vehicle-controlled, double-blind, parallel-group hybrid clinical trial in adults with multiple AK lesions Olsen grade 1 or 2. The hybrid design combines decentralised participant tasks and assessments with conventional in-clinic visits. Recruitment using targeted advertising on social media and eligibility prescreening are conducted via the Studies&Me online recruitment platform. Participants (n=60) are randomly assigned to 1 of 3 treatment arms: AVX001 gel 1%, AVX001 gel 3% or vehicle gel. The trial consists of a 4-week treatment period with daily field-directed topical application of the gel and an 8-week follow-up period. Participants attend in-clinic visits at baseline, week 4 and week 12. The remote participant trial tasks include questionnaires and upload of smartphone-obtained photos of the treated skin area using a study-specific web-based app. Both remote and in-clinic assessments of safety and efficacy will be performed. The primary objective is to evaluate the local tolerability of daily application of AVX001 gel (1% or 3%) compared with vehicle gel. Secondary objectives include safety, efficacy, dose-response efficacy relationship, treatment satisfaction and cosmetic outcome. Exploratory objectives include evaluations of tolerability and efficacy assessed by dermatologists using smartphone photos uploaded by participants, comparisons of in-clinic and remote assessments and assessment of AK-related skin changes by non-invasive optical imaging., Ethics and Dissemination: Approved by the Ethics Committee of the Capital Region of Denmark (H-21018064) and the Danish Medicines Agency (2021032485). Results will be submitted for publication in peer-reviewed scientific journals., Trial Registration Numbers: 2021-000934-32; NCT05164393., Competing Interests: Competing interests: ADA, KK, ACM, CPL, JRZ, API, MLME and ER were employed at Studies&Me for the present work, a clinical research organisation that has been contracted by Coegin Pharma to conduct the present study; TD is the CEO of the sponsor company Coegin Pharma; TD, BJ, AJF and FJA are shareholders and stock option holders of Coegin Pharma; BJ, AJF and FJA have received consulting fees from Coegin Pharma with patents planned; JK is a board member at Coegin Pharma and has received consulting fees from Coegin Pharma; IM has received consulting fees from Studies&Me; VKO has been employed at LEO Pharma AB and has received research grants from Innovation Fund Denmark; MH has received research grants from Studies&Me, LEO Pharma, Lutronic, Mirai Medical and Venus Concept and equipment from Cherry Imaging, Cynosure, Lutronic, Venus Concept, Perfaction Technologies, MiraDry Sientra and Mirai Medical; MH has delivered lectures/teaching for Galderma Nordic., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2022
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27. Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study.
- Author
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Laugesen C, Ranjan AG, Schmidt S, and Nørgaard K
- Subjects
- Adult, Blood Glucose, Cross-Over Studies, Glucagon analogs & derivatives, Humans, Hypoglycemic Agents adverse effects, Insulin adverse effects, Diabetes Mellitus, Type 1, Hypoglycemia chemically induced, Hypoglycemia prevention & control
- Abstract
Objective: To compare the efficacy of low-dose subcutaneous dasiglucagon with oral glucose for prevention of insulin-induced hypoglycemia in people with type 1 diabetes., Research Design and Methods: Twenty adults with type 1 diabetes using multiple daily injection or insulin pump therapy completed a phase 2, randomized, three-arm crossover study. On each study visit, an individualized subcutaneous insulin bolus was administered aiming for a plasma glucose (PG) concentration of 3.0 mmol/L (54 mg/dL). When a PG concentration of 4.5 mmol/L (81 mg/dL) was reached, 15 g oral glucose (CHO) from dextrose tablets, 80 µg dasiglucagon (D80), or 120 µg dasiglucagon (D120) was administered. PG was measured frequently for the following 180 min., Results: Hypoglycemia (<3.9 mmol/L [70 mg/dL]) occurred in 10 participants after CHO, in 5 after D80, and in 4 after D120 (CHO vs. D80, P = 0.096; CHO vs. D120, P = 0.034). Time spent in hypoglycemia (<3.9 mmol/L [70 mg/dL]) was 14%, 7%, and 6% for CHO, D80, and D120, respectively (P = 0.273). The median time (95% CI) from intervention to first increase in PG of 1.1 mmol/L (20 mg/dL) was 30 (25-50), 15 (15-20), and 15 (15-20) minutes for CHO, D80, and D120, respectively (CHO vs. D80, P = 0.006; CHO vs. D120, P = 0.003). Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. No significant differences in visual analog scale-assessed adverse effects were observed between interventions., Conclusions: Low-dose dasiglucagon safely and effectively prevented insulin-induced hypoglycemia with a faster glucose-elevating profile than oral glucose., (© 2022 by the American Diabetes Association.)
- Published
- 2022
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28. Similar real-world two-year visual acuity gains in treatment-naive patients with diabetic macular oedema treated with a loading dose of three initial monthly injections versus less intensive regimens of intravitreal anti-vascular endothelial growth factor.
- Author
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Lindboe JB, Schmidt Laugesen C, Sørensen TL, and Brynskov T
- Subjects
- Aged, Diabetic Retinopathy diagnostic imaging, Diabetic Retinopathy physiopathology, Female, Humans, Intravitreal Injections, Macular Edema diagnostic imaging, Macular Edema physiopathology, Male, Middle Aged, Retrospective Studies, Tomography, Optical Coherence, Vascular Endothelial Growth Factor A antagonists & inhibitors, Angiogenesis Inhibitors administration & dosage, Diabetic Retinopathy drug therapy, Macular Edema drug therapy, Ranibizumab administration & dosage, Receptors, Vascular Endothelial Growth Factor administration & dosage, Recombinant Fusion Proteins administration & dosage, Visual Acuity physiology
- Published
- 2021
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29. Smartphone data offer insights into disease activity and triggers in atopic dermatitis: a fully decentralized remote longitudinal pilot study.
- Author
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Eiken A, Laugesen CP, Isberg A, Thomsen SF, Ali Z, Chiriac A, Dutei AM, Deaconescu I, Manole I, Valk TJ, Andersen AD, and Zibert JR
- Subjects
- Humans, Longitudinal Studies, Pilot Projects, Smartphone, Dermatitis, Atopic, Eczema
- Published
- 2021
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30. The effect of preceding glucose decline rate on low-dose glucagon efficacy in individuals with type 1 diabetes: A randomized crossover trial.
- Author
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Laugesen C, Schmidt S, Holst JJ, Nørgaard K, and Ranjan AG
- Subjects
- Adult, Blood Glucose, Blood Glucose Self-Monitoring, Cross-Over Studies, Double-Blind Method, Glucose, Humans, Hypoglycemic Agents, Insulin, Single-Blind Method, Diabetes Mellitus, Type 1 drug therapy, Glucagon
- Abstract
Identifying determinants of low-dose glucagon efficacy is important to optimise its utilization for prevention and treatment of hypoglycaemia in individuals with type 1 diabetes. The study objective was to investigate whether the preceding glucose decline rate affects glucose response to low-dose glucagon administration. Ten adults with insulin pump-treated type 1 diabetes were included in this randomized, single-blind, two-way crossover study. Using a hyperinsulinaemic clamp technique, plasma glucose levels were reduced with either a rapid or slow decline rate while maintaining fixed insulin levels. When the plasma glucose level reached 3.9 mmoL/L, insulin and glucose infusions were discontinued and 150 μg subcutaneous glucagon was administered, followed by 120 minutes of plasma glucose monitoring. The positive incremental area under the glucose curve after administration of low-dose glucagon did not differ between the rapid-decline and slow-decline visits (mean ± SEM: 220 ± 49 vs. 174 ± 31 mmoL/L x min; P = 0.21). Similarly, no differences in total area under the glucose curve, peak plasma glucose, incremental peak plasma glucose, time-to-peak plasma glucose or end plasma glucose were observed. Thus, preceding glucose decline rate did not significantly affect the glucose response to low-dose glucagon., (© 2020 John Wiley & Sons Ltd.)
- Published
- 2021
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31. Effect of adjunctive glucose-lowering drugs on body weight in people with type 1 diabetes: a systematic review and network meta-analysis protocol.
- Author
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Laugesen C, Ranjan AG, Schmidt S, Rasmussen LN, Nørgaard O, Christensen R, and Nørgaard K
- Subjects
- Adult, Humans, Bayes Theorem, Body Weight, Diabetes Mellitus, Type 2, Glucose, Network Meta-Analysis, Pharmaceutical Preparations, Meta-Analysis as Topic, Systematic Reviews as Topic, Diabetes Mellitus, Type 1 drug therapy
- Abstract
Introduction: Obesity increases the risk of comorbidities and diabetes-related complications and, consequently, efforts to prevent and reduce excess weight in people with type 1 diabetes are essential. The aim of this systematic review and network meta-analysis is to assess the effect of adjunctive glucose-lowering drugs on body weight and other important health outcomes in people with type 1 diabetes., Methods and Analysis: This systematic review and network meta-analysis will include randomised controlled trials (RCTs) evaluating the use of adjunctive glucose-lowering drugs for treatment of people with type 1 diabetes. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched from inception to present. Key eligibility criteria include: RCT study design; adult participants with type 1 diabetes; treatment with a glucose-lowering drug for ≥24 weeks; and comparison of the intervention to placebo, usual care or another glucose-lowering drug. The primary outcome is change in body weight. Other major outcomes include change in HbA1c and total daily insulin dose and risk of hypoglycaemia and other adverse events. Dual study selection, data extraction and risk of bias assessment will be performed. Results from the meta-analysis will be presented as weighted mean differences for continuous outcomes and risk ratios for dichotomous outcomes. Sources of heterogeneity will be explored by subgroup and sensitivity analysis. A network meta-analysis for the primary outcome will be performed using an arm-based random-effects model based on the Bayesian framework while assessing for transitivity across studies and consistency between direct and indirect estimates. The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach for each outcome., Ethics and Dissemination: No ethical assessment is required. The results of this review will be disseminated through peer-reviewed publication and conference presentation., Prospero Registration Number: CRD42020158676., Competing Interests: Competing interests: CL, AGR, SS, LNR, ON and RC have nothing to disclose. KN owns shares in Novo Nordisk and has received research grants and fees for lecturing from Novo Nordisk and Zealand Pharma. No other potential conflicts of interest relevant to this article were reported., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2020
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32. Glucose Sensor Accuracy After Subcutaneous Glucagon Injections Near to Sensor Site.
- Author
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Laugesen C, Schmidt S, Tetzschner R, Nørgaard K, and Ranjan AG
- Subjects
- Abdomen, Adolescent, Adult, Aged, Diabetes Mellitus, Type 1 drug therapy, Female, Humans, Insulin Infusion Systems, Male, Materials Testing, Middle Aged, Reference Values, Reproducibility of Results, Young Adult, Blood Glucose analysis, Blood Glucose Self-Monitoring instrumentation, Diabetes Mellitus, Type 1 blood, Glucagon administration & dosage, Hypoglycemic Agents administration & dosage, Injections, Subcutaneous methods
- Abstract
Background: Integrated hormone delivery and glucose sensing is warranted, but system performance could be challenged by glucose sensor susceptibility to pharmacological interferences. The aim of this study was to compare sensor accuracy (Medtronic Enlite 2
® ) after subcutaneous (s.c.) administration of low-dose glucagon near to versus remote from sensor site. Methods: Twelve adults with insulin-pump-treated type 1 diabetes wore two continuous glucose monitors (CGMglucagon and CGMcontrol ) placed on each side of the abdomen before, during, and after two overnight 14-h in-clinic visits. During each visit, a s.c. 100 μg glucagon injection was administered 2 cm next to the CGMglucagon followed by another injection of 100 μg glucagon 2 h later at the same site. CGM performance was evaluated using 4-h in-clinic Yellow Spring Instrument (YSI) measurements and 3-day self-monitoring of blood glucose (SMBG) in free-living conditions. Results: Using YSI as comparator, no difference in the median absolute relative difference (MARD) for CGMglucagon (15.7%) and CGMcontrol (13.4%) was found ( P = 0.195). Similarly, no difference in MARD was found between CGMglucagon (11.0%) and CGMcontrol (6.2%) using SMBG as comparator ( P = 0.148). Values in zone A + B of Clarke error grid analysis did not differ between CGMglucagon and CGMcontrol using YSI (93.9% vs. 91.1%, P = 0.250) and SMBG (97.3% vs. 95.0%, P = 0.375) as reference measurement. The precision absolute relative deviation between sensors was 13.7%. Conclusions: Sensor accuracy was not significantly affected by administration of s.c. glucagon near to sensor site.- Published
- 2020
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33. Scandinavian Multicenter Acute Subdural Hematoma (SMASH) Study: Study Protocol for a Multinational Population-Based Consecutive Cohort.
- Author
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Bartek J Jr, Laugesen C, Mirza S, Forsse A, Petersen MA, Corell A, Dyhrfort PW, Redebrandt HN, Reen L, Zolfaghari S, Tobieson L, Carlsvärd B, Bergholt B, Bashir A, Soerensen P, Bilgin A, Johansson C, Lindvall P, Förander P, Bellander BM, Springborg JB, and Jakola AS
- Subjects
- Adult, Aged, Cohort Studies, Denmark epidemiology, Female, Humans, Male, Middle Aged, Prognosis, Retrospective Studies, Sweden epidemiology, Tomography, X-Ray Computed, Treatment Outcome, Hematoma, Subdural, Acute mortality, Research Design
- Abstract
Background: Traumatic acute subdural hematomas (ASDHs) are associated with high rate of morbidity and mortality, especially in elderly individuals. However, recent reports indicate that the morbidity and mortality rates might have improved., Objective: To evaluate postoperative (30-d) mortality in younger vs elderly (≥70 yr) patients with ASDH. Comparing younger and elderly patients, the secondary objectives are morbidity patterns of care and 6 mo outcome according to Glasgow outcome scale (GOS). Finally, in patients with traumatic ASDH, we aim to provide prognostic variables., Methods: This is a large-scale population-based Scandinavian study including all neurosurgical departments in Denmark and Sweden. All adult (≥18 yr) patients surgically treated between 2010 and 2014 for a traumatic ASDH in Denmark and Sweden will be included. Identification at clinicaltrials.gov is NCT03284190., Expected Outcomes: We expect to provide data on potential differences between younger vs elderly patients in terms of mortality and morbidity. We hypothesize that elderly patients selected for surgery have a similar pattern of care as compared with younger patients. We will provide functional outcome in terms of GOS at 6 mo in younger vs elderly patients undergoing ASDH evacuation. Finally, clinical useful prognostic factors for favorable (GOS 4-5) vs unfavorable (GOS 1-3) will be identified., Discussion: An improved understanding of the clinical outcome, treatment and resource allocation, clinical course, and the prognostic factors of traumatic ASDH will allow neurosurgeons to make better treatment decisions., (Copyright © 2018 by the Congress of Neurological Surgeons.)
- Published
- 2019
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34. Pharmacokinetics of intravitreal 5-fluorouracil prodrugs in silicone oil: experimental studies in pigs.
- Author
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Schmidt Laugesen C, Steffansen B, Scherfig E, and la Cour M
- Subjects
- Animals, Body Water metabolism, Chromatography, High Pressure Liquid, Half-Life, Models, Theoretical, Swine, Vitreous Body surgery, Antimetabolites, Antineoplastic pharmacokinetics, Fluorouracil pharmacokinetics, Prodrugs pharmacokinetics, Silicone Oils, Vitrectomy, Vitreous Body metabolism
- Abstract
Purpose: To examine the in vivo pharmacokinetics of intravitreal 5-Fluorouracil (5-FU) following tamponade with 5-FU prodrug silicone oil formulations., Method: Two different alkoxycarbonyl 5-FU prodrugs denoted C12 and C18 were synthesized and formulated as silicone oil suspensions. A total of 26 pigs underwent conventional three-port lens-sparing pars plana vitrectomy. Approximately 1.6 ml of the prodrug-silicone oil formulation was placed in the vitreous cavity. Operated eyes were enucleated between 20 min and 168 hours postoperatively, and analysed for their content of free 5-FU by high performance liquid chromatography., Results: With the C12 prodrug silicone oil formulation, the concentration of free 5-FU in the vitreous water phase 1 hour after surgery was 3.30 +/- 1.62 microg/ml. After 4 hours this concentration had declined to 1 microg/ml. With the C18 prodrug, the concentration of free vitreal 5-FU never reached 1 microg/ml during the 7 days these experiments lasted. A mathematical model is presented that can explain the measured data if the clearance of 5-FU from the vitreous water phase follows first order kinetics with a half-life of 20 min., Conclusion: These experiments, and the model analysis, suggest that the elimination half-life of 5-FU in the vitreous cavity of a vitrectomized, silicone oil-filled eye is very fast. The model analysis indicates that an alkoxycarbonyl 5-FU prodrug with a specific release rate constant of 10.7 microg/square root h cm(2) can maintain an intravitreal 5-FU concentration above 1 microg/ml for 5 days in the porcine eye.
- Published
- 2005
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35. A prospective study of combined phacoemulsification-trabeculectomy versus conventional phacoemulsification in cataract patients with coexisting open angle glaucoma.
- Author
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Storr-Paulsen A, Pedersen JH, and Laugesen C
- Subjects
- Aged, Aged, 80 and over, Female, Glaucoma, Open-Angle surgery, Humans, Intraocular Pressure, Male, Middle Aged, Prospective Studies, Treatment Outcome, Visual Acuity, Cataract complications, Glaucoma, Open-Angle complications, Phacoemulsification, Trabeculectomy
- Abstract
This prospective study compares combined phacoemulsification and trabeculectomy (phaco-trab) to conventional phacoemulsification (phaco) in patients with coexisting cataract and open angle glaucoma. Twenty eyes were randomly assigned to either phaco-trab or phaco and followed for 12 months. Postoperatively, IOP decreased significantly in both groups, but patients with the combined procedure had fewer early IOP-elevations and significantly less medication. Visual acuity improved equally in the two groups.
- Published
- 1998
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