| 1. |
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| 2. |
- Helgesson, Gert, et al.
(författare)
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Limited Relevance of the Right Not to Know : Reflections on a Screening Study
- 2007
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Ingår i: Accountability in Research. - : Informa UK Limited. - 0898-9621 .- 1545-5815. ; 14:3, s. 197-209
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Tidskriftsartikel (refereegranskat)abstract
- The right not to know personal health-related information has been included in prominent human rights documents and subsequently in national legislation since the middle of the 1990s. Apart from situations where another life is at stake, the right not to know has in these documents been formulated as if it should have precedence over other interests. This article argues against giving the right not to know such a prominent position. It does so by questioning the ethical relevance of the concept for both theoretical and empirical reasons. The main focus of the article is on empirical data from a prospective population screening for Type 1 diabetes. Data indicate that research participants are not as autonomous as is generally assumed by the defenders of the right not to know.
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| 3. |
- Helgesson, Gert, et al.
(författare)
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Practical matters, rather than lack of trust, motivate non-participation in a long-term cohort trial
- 2009
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Ingår i: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X .- 1399-5448. ; 10:6, s. 408-412
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective of this study was to investigate the importance of trust in researchers and other reasons that participating parents, former participants, and non-participants had for participating, or not participating, in a longitudinal cohort study on prediction and development of diabetes in children. Study design: A questionnaire addressing each of these groups, where respondents graded the importance of a set of listed reasons for participating/not participating, was randomly distributed to 2500 families in the All Babies in Southeast Sweden (ABIS) study region with children born between 1997 and 1999. Results: Lack of trust was not a central factor to a great majority of respondents who decided not to participate in the ABIS study or who later decided to opt out. Practical matters, like blood sampling and lack of time, were important factors to many more. Yet, four fifths of those who still participate in the ABIS study stated trust in the researchers to be an important factor to their initial decision to participate. Conclusions: Trust in researchers may be a necessary prerequisite in order for people to be willing to participate in research, but practical matters such as time that has to be spent or pain involved in collecting blood were more important factors than lack of trust in explaining opt out in relation to the ABIS study.
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| 4. |
- Helgesson, Gert, et al.
(författare)
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Views on data use, confidentiality and consent in a predictive screening involving children
- 2008
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Ingår i: Journal of Medical Ethics. - : BMJ. - 0306-6800 .- 1473-4257. ; 34:3, s. 206-209
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Tidskriftsartikel (refereegranskat)abstract
- Data from the 5-6 year control questionnaire of the ABIS study, a Swedish prospective screening of children for Type 1 diabetes, indicates a genuine trust in the researchers - very few participating families expressed concern about their participation. Nevertheless, a majority do not want their research data to be used beyond the agreement of the original consent. They want to be asked for renewed consent in such cases. A vast majority also want potential high-risk information about their child to be communicated to them. Most participating families want this regardless of whether any preventive treatment is available. Although potential benefits for their child is a motivation for participation for a majority of the respondents, they also claim to be motivated by altruistic reasons. These results are compared to results from two similar studies in the UK.
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| 5. |
- Lernmark, Barbro, et al.
(författare)
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Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.
- 2016
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Ingår i: Journal of Diabetes Research. - : Hindawi Limited. - 2314-6753 .- 2314-6745. ; 2016
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Tidskriftsartikel (refereegranskat)abstract
- Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Conclusions. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.
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| 6. |
- Lundgren, Markus, et al.
(författare)
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Analgesic antipyretic use among young children in the TEDDY study : No association with islet autoimmunity
- 2017
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Ingår i: BMC Pediatrics. - : Springer Science and Business Media LLC. - 1471-2431. ; 17:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: The use of analgesic antipyretics (ANAP) in children have long been a matter of controversy. Data on their practical use on an individual level has, however, been scarce. There are indications of possible effects on glucose homeostasis and immune function related to the use of ANAP. The aim of this study was to analyze patterns of analgesic antipyretic use across the clinical centers of The Environmental Determinants of Diabetes in the Young (TEDDY) prospective cohort study and test if ANAP use was a risk factor for islet autoimmunity. Methods: Data were collected for 8542 children in the first 2.5 years of life. Incidence was analyzed using logistic regression with country and first child status as independent variables. Holm's procedure was used to adjust for multiplicity of intercountry comparisons. Time to autoantibody seroconversion was analyzed using a Cox proportional hazards model with cumulative analgesic use as primary time dependent covariate of interest. For each categorization, a generalized estimating equation (GEE) approach was used. Results: Higher prevalence of ANAP use was found in the U.S. (95.7%) and Sweden (94.8%) compared to Finland (78.1%) and Germany (80.2%). First-born children were more commonly given acetaminophen (OR 1.26; 95% CI 1.07, 1.49; p = 0.007) but less commonly Non-Steroidal Anti-inflammatory Drugs (NSAID) (OR 0.86; 95% CI 0.78, 0.95; p = 0.002). Acetaminophen and NSAID use in the absence of fever and infection was more prevalent in the U.S. (40.4%; 26.3% of doses) compared to Sweden, Finland and Germany (p < 0.001). Acetaminophen or NSAID use before age 2.5 years did not predict development of islet autoimmunity by age 6 years (HR 1.02, 95% CI 0.99-1.09; p = 0.27). In a sub-analysis, acetaminophen use in children with fever weakly predicted development of islet autoimmunity by age 3 years (HR 1.05; 95% CI 1.01-1.09; p = 0.024). Conclusions: ANAP use in young children is not a risk factor for seroconversion by age 6 years. Use of ANAP is widespread in young children, and significantly higher in the U.S. compared to other study sites, where use is common also in absence of fever and infection.
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| 7. |
- Roth, Roswith, et al.
(författare)
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Maternal anxiety about a child's diabetes risk in the TEDDY study: the potential role of life stress, postpartum depression, and risk perception
- 2015
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Ingår i: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X. ; 16:4, s. 287-298
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveTo understand the association between life stress, postpartum depression (PD), maternal perception of her child's risk for type 1 diabetes (T1D) and a mother's anxiety about her child's T1D risk in mothers of genetically at risk children in The Environmental Determinants of Diabetes in the Young (TEDDY) study. MethodsA short form of the state component (SAI) of the State-Trait Anxiety Inventory, negative life events (LE), the Edinburgh Postnatal Depression Scale (EPDS), and one question about the child's risk of developing T1D risk perceptions (RP) were given to mothers at the 6-month TEDDY clinic visit. The relationship between the four measures was modeled using multiple regressions. ResultsControlling for sociodemographic factors, significant country differences in SAI, LE, EPDS, and RP emerged. LE - particularly interpersonal LE - had a strong association to maternal anxiety about the baby's risk of diabetes. Both evidence of PD and accurate risk perceptions (RPs) about the child's T1D risk were associated with increased maternal anxiety about the child's T1D risk. ConclusionHeightened maternal anxiety in response to the news that a child is at increased risk for T1D is common. Mothers who have experienced recent negative LE, who experience PD and who accurately understand their child's risk may be particularly vulnerable to high levels of anxiety. The findings reported here need to be confirmed in future prospective studies.
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| 8. |
- Smith, Laura B., et al.
(författare)
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Psychological manifestations of celiac disease autoimmunity in young children
- 2017
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Ingår i: Pediatrics. - : American Academy of Pediatrics (AAP). - 0031-4005 .- 1098-4275. ; 139:3
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND OBJECTIVES: Psychological symptoms can be associated with celiac disease; abstract however, this association has not been studied prospectively in a pediatric cohort. We examined mother report of psychological functioning in children persistently positive for tissue transglutaminase autoantibodies (tTGA), defined as celiac disease autoimmunity (CDA), compared with children without CDA in a screening population of genetically at-risk children. We also investigated differences in psychological symptoms based on mothers' awareness of their child's CDA status. METHODS: The Environmental Determinants of Diabetes in the Young study followed 8676 children to identify triggers of type 1 diabetes and celiac disease. Children were tested for tTGA beginning at 2 years of age. The Achenbach Child Behavior Checklist assessed child psychological functioning at 3.5 and 4.5 years of age. RESULTS: At 3.5 years, 66 mothers unaware their child had CDA reported more child anxiety and depression, aggressive behavior, and sleep problems than 3651 mothers of children without CDA (all Ps ≤ .03). Unaware-CDA mothers also reported more child anxiety and depression, withdrawn behavior, aggressive behavior, and sleep problems than 440 mothers aware of their child's CDA status (all Ps ≤.04). At 4.5 years, there were no differences. CONCLUSIONS: In 3.5-year-old children, CDA is associated with increased reports of child depression and anxiety, aggressive behavior, and sleep problems when mothers are unaware of their child's CDA status. Mothers' knowledge of their child's CDA status is associated with fewer reports of psychological symptoms, suggesting that awareness of the child's tTGA test results affects reporting of symptoms.
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| 9. |
- Swartling, Ulrica, et al.
(författare)
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Children's Views on Long-Term Screening for Type 1 Diabetes.
- 2014
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Ingår i: Journal of Empirical Research on Human Research Ethics. - : SAGE Publications. - 1556-2654 .- 1556-2646. ; 9:4, s. 1-9
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Tidskriftsartikel (refereegranskat)abstract
- There are an increasing number of medical research studies involving children, including many long-term birth cohort studies. Involving children raises many issues, and little is known about children's own views. This study explored children's views (N = 5,851) on participation in a long-term screening study for type 1 diabetes. The results show that children 10 to 13 years of age have in general a positive attitude to pediatric research and emphasized trust in researchers. The children stressed the importance to receive information and to be involved in decisions. The children also reported feeling concerned about blood sampling and disease risk. Researchers involved in long-term pediatric research need to address these issues to promote involvement and decrease worry.
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| 10. |
- Swartling, Ulrica, 1965-, et al.
(författare)
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Concern, pressure and lack of knowledge affect choice of not wanting to know high-risk status
- 2007
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Ingår i: European Journal of Human Genetics. - : Springer Science and Business Media LLC. - 1018-4813 .- 1476-5438. ; 15:5, s. 556-562
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Tidskriftsartikel (refereegranskat)abstract
- The 'right not to know' one's genetic status has been increasingly more recognised in ethical and legal instruments. Yet empirical research is limited, leaving discussion on a theoretical level. There are also divergent ideas as to what extent it should be respected. In this study, we explored the clinical preconditions for disclosure of increased risk of getting diabetes in children. We included questions in the clinical 5-year questionnaire of a predictive screening for the risk of type 1 diabetes (T1DM), asking the respondents (n=7206) whether they wished to be informed of their children's potential risk status. The group of 2% of the respondents who did not want to know about risk status proved to be significantly associated to concern with natural history data (OR 4.03), lack of knowledge (OR 3.17), pressure to participate (OR 2.99) and the child's disease development (OR 2.18). We discuss whether parents'/participants' 'no' to high-risk information may call for a more nuanced response such as information and support, rather than simply respect their wish not to know. We furthermore argue that it is ethically questionable whether the parents' expressed wish not to know should prima facie override the potential benefits for their child. We conclude that this constitutes sufficient reason not to promote a default solution where people's expressed wishes not to know are taken at face value.
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| 11. |
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| 12. |
- Swartling, Ulrica, 1965-, et al.
(författare)
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"My parents decide if I can. I decide if I want to." Children’s views on participation in medical research
- 2011
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Ingår i: Journal of Empirical Research on Human Research Ethics. - : University of California Press. - 1556-2646 .- 1556-2654. ; 6:4, s. 68-74
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Tidskriftsartikel (refereegranskat)abstract
- The participation of children in medical research raises many ethical issues, in particular regarding assent. However, little is known about children's own views on participation. This study presents results from interviews with children 10–12 years old with and without experience in a large-scale longitudinal screening study. We identified five themes: (1) knowledge about research, (2) a sense of altruism, (3) shared decision-making and right to dissent, (4) notions of integrity, privacy, and access, and (5) understanding of disease risk and personal responsibilities. We conclude that the children feel positive towards medical research, and want to take an active part in decisions and have their integrity respected. However, the study also indicates that children who had participated in longitudinal screening had a limited understanding, suggesting the vital importance of providing information appropriate to their age and maturity. This information should be provided out of respect for the children as persons, but also to promote their willingness to continue participating in longitudinal studies.
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| 13. |
- Swartling, Ulrica, et al.
(författare)
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Parental authority, research interest and children's right to decide in medical research - an uneasy tension?
- 2008
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Ingår i: Clinical Ethics. - : SAGE Publications. - 1477-7509 .- 1758-101X. ; 3:2, s. 69-74
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Tidskriftsartikel (refereegranskat)abstract
- There is an increased focus on, and evidence of, children's capability to both understand and make decisions about issues relating to participation in medical research. At the same time there are divergent ideas of when, how and to what extent children should be allowed to decide for themselves. Furthermore, little is known about parents' views on these matters, an important issue since they often provide the formal consent. In this questionnaire study of 2500 families in south-east Sweden (with and without research experience) we explored parents' views on issues relating to information, consent and research data. We found that parents are generally positive about supplying their child with individual information (93.3%; median age 7) and assuring the child's consent/assent to participation (74.3%; median age 12). However, parents' views vary regarding the extent to which children should influence research data: as many as 47–61% of our sample were opposed to children's rights to decide about the use and storage of biological samples and natural history data. Parents who are opposed to child consent and a wider influence on their research participation argue that parental authority and research quality are two important factors opposing enhanced child influence. Drawing on this, we underline the need to discuss how to balance children's rights against parental autonomy and research interests before implementing any standardized protocols granting children the right to consent and revoke data in long-term research.
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| 14. |
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| 15. |
- Swartling, Ulrica, et al.
(författare)
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Parental estimation of their child's increased type 1 diabetes risk during the first 2 years of participation in an international observational study : Results from the TEDDY study
- 2016
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Ingår i: Journal of Empirical Research on Human Research Ethics. - : SAGE Publications. - 1556-2646 .- 1556-2654. ; 11:2, s. 106-114
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Tidskriftsartikel (refereegranskat)abstract
- This study assessed mothers' and fathers' perception of their child's risk of getting type I diabetes (TID) during the first 2 years of their participation in The Environmental Determinants of Diabetes in the Young (TEDDY) study. TEDDY parents were informed of their child's increased genetic risk for Tl D at study inception. Parent perception of the child's risk was assessed at 3, 6, 15, and 27 months of age. In families with no history of TID, underestimation of the child's TID risk was common in mothers (>38%) and more so in fathers (>50%). The analyses indicated that parental education, country of residence, family history of TID, household crowding, ethnic minority status, and beliefs that the child's TID risk can be reduced were factors associated with parental risk perception accuracy. Even when given extensive information about their child's TID risk, parents often fail to accurately grasp the information provided. This is particularly true for fathers, families from low socioeconomic backgrounds, and those with no family history of Tl D. It is important to develop improved tools for risk communication tailored to individual family needs.
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| 16. |
- Swartling, Ulrica, 1965-, et al.
(författare)
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Self-assessed understanding as a tool for evaluating consent : reflections on a longitudinal study
- 2008
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Ingår i: Journal of Medical Ethics. - : BMJ. - 0306-6800 .- 1473-4257. ; 34:7, s. 557-562
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Tidskriftsartikel (refereegranskat)abstract
- Based on extensive clinical questionnaire data, this paper explores the relation between research subjects' self-assessed understanding and actual knowledge of a largescale predictive screening study, and its implications for the proper handling of information and consent routines in longitudinal studies. The intitial data show that low self-assessed understanding among participants was correlated with limited knowledge, concern over participation and collected samples, less satisfaction with information, and feeling passive or negative towards the study. Among those reporting high understanding, a non-negligible number displayed a lack of knowledge regarding central aspects of the study. Regarding high assessed understanding, the multivariate analysis identified the main predictor variables to be knowledge, having a positive attitude towards participation and the study itself, being satisfied with information, having a stable psychosocial background and feeling calm regarding the handling of samples. These findings indicate that to evaluate participants' understanding through self-assessment may not be reliable method. Self-assessed understanding may rather be a good indicator of general attitudes than a tool for analysing content. The data also show that actual understanding varies considerably among participants, suggesting that more effort needs to be put into adjusting the information to the needs of different subgroups. It is argued that when doing this, researchers in longitudinal studies must be careful not to exhaust participants with excessive information that they do not want and that may cause them to drop out. The ethical relevance of obtaining repeated consents in longitudinal research is discussed.
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| 17. |
- Swartling, Ulrica, et al.
(författare)
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Split views among parents regarding children's right to decide about participation in research : a questionnaire survey
- 2009
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Ingår i: Journal of Medical Ethics. - : BMJ. - 0306-6800 .- 1473-4257. ; 35:7, s. 450-455
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Tidskriftsartikel (refereegranskat)abstract
- Based on extensive questionnaire data, this paper focuses on parents' views about children's right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings.
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| 18. |
- Tercyak, Kenneth P, et al.
(författare)
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Behavioral Science Research Informs Bioethical Issues in the Conduct of Large-Scale Studies of Children's Disease Risk.
- 2013
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Ingår i: AJOB Primary Research. - : Taylor & Francis. - 2150-7716 .- 2150-7724. ; 4:3, s. 4-14
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Birth cohort studies of the natural history of pediatric common disease risk raise many bioethical issues, including re-consenting participants over time as children mature and cohort retention. Understanding participants' study-specific knowledge, attitudes, beliefs, and behavior may offer insights into these issues from a psychological perspective.METHODS: We conducted an analysis of factors associated with parent-child communication about minor children's participation in a population-based birth cohort; children's knowledge about their own participation; and parental willingness to be re-contacted for future study among Swedish parents (N = 3,605) of children originally enrolled at birth in a prospective study of type 1 diabetes risk.RESULTS: More open parent-child communication about disease risk screening research and greater knowledge among children about their own research participation facilitated greater parent willingness to participate in further study. Parents' decisions about further study participation were most strongly favorable among those who communicated openly with their child and with high study-specific knowledge.CONCLUSIONS: Epidemiologists, bioethicists, and others involved in the design and conduct of large-scale, prospective birth cohorts may consider embedding periodic assessments of participants' study-specific attitudes and behavior to address long-term retention and willingness to engage in future research.
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| 19. |
- Tercyak, Kenneth P, et al.
(författare)
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Psychometric properties of the Pediatric Testing Attitudes Scale-Diabetes (P-TAS-D) for parents of children undergoing predictive risk screening
- 2013
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Ingår i: Pediatric Diabetes. - : Wiley-Blackwell. - 1399-543X .- 1399-5448. ; 14:8, s. 602-610
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveExamine the factor structure, reliability, and validity of the Pediatric Testing Attitudes Scale-Diabetes (P-TAS-D), a measure of parental attitudes about predictive risk screening for type 1 diabetes in children. less thanbrgreater than less thanbrgreater thanMethodsSurveys were completed by 3720 Swedish parents of children participating in the adolescent follow-up of a birth cohort study of type 1 diabetes onset. Parents averaged 43.5years, 42.3% were college-educated, and 10.6% of children had a family history of type 1 diabetes. The parent sample was randomly divided, an exploratory factor analysis (EFA; n =1860) was conducted, followed by confirmatory factor analysis (CFA; n =1860) and testing. less thanbrgreater than less thanbrgreater thanResultsEFA/CFA revealed the P-TAS-D has three factors/scales: Attitudes and Beliefs toward type 1 diabetes predictive risk screening (=0.92), Communication about risk screening results (=0.71), and Decision Making (r = 0.19, pandlt;0.001). This solution fit the data well ((2) [42]=536.0, RMSEA = 0.08, CFI = 0.95) and internal consistency for the full scale was high (=0.86, M = 36.2, SD = 8.2). After adjusting for covariates, more favorable attitudes toward childrens risk screening were associated with greater worry about type 1 diabetes (B = 1.1, p andlt;0.001), less worry about health overall (B = -0.10, p = 0.001), and more positive attitudes toward (B = 0.28, p andlt;0.001) and less worry about (B = 0.41, p andlt;0.001) diabetes research. less thanbrgreater than less thanbrgreater thanConclusionsThe P-TAS-D is a stable, reliable, and valid measure for assessing parents type 1 diabetes risk screening attitudes. Scale data can help target parent education efforts in risk screening trials.
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| 20. |
- Törn, Carina, et al.
(författare)
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Complement gene variants in relation to autoantibodies to beta cell specific antigens and type 1 diabetes in the TEDDY Study
- 2016
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- A total of 15 SNPs within complement genes and present on the ImmunoChip were analyzed in The Environmental Determinants of Diabetes in the Young (TEDDY) study. A total of 5474 subjects were followed from three months of age until islet autoimmunity (IA: n = 413) and the subsequent onset of type 1 diabetes (n = 115) for a median of 73 months (IQR 54-91). Three SNPs within ITGAM were nominally associated (p < 0.05) with IA: rs1143678 [Hazard ratio; HR 0.80; 95% CI 0.66-0.98; p = 0.032], rs1143683 [HR 0.80; 95% CI 0.65-0.98; p = 0.030] and rs4597342 [HR 1.16; 95% CI 1.01-1.32; p = 0.041]. When type 1 diabetes was the outcome, in DR3/4 subjects, there was nominal significance for two SNPs: rs17615 in CD21 [HR 1.52; 95% CI 1.05-2.20; p = 0.025] and rs4844573 in C4BPA [HR 0.63; 95% CI 0.43-0.92; p = 0.017]. Among DR4/4 subjects, rs2230199 in C3 was significantly associated [HR 3.20; 95% CI 1.75-5.85; p = 0.0002, uncorrected] a significance that withstood Bonferroni correction since it was less than 0.000833 (0.05/60) in the HLA-specific analyses. SNPs within the complement genes may contribute to IA, the first step to type 1 diabetes, with at least one SNP in C3 significantly associated with clinically diagnosed type 1 diabetes.
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| 21. |
- Åkerman, Linda, et al.
(författare)
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Characteristics of the pre-diabetic period in children with high risk of type 1 diabetes recruited from the general Swedish population-The ABIS study
- 2017
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Ingår i: Diabetes/Metabolism Research and Reviews. - : Wiley. - 1520-7552 .- 1520-7560. ; 33:6
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Tidskriftsartikel (refereegranskat)abstract
- Background: There is a need for increased understanding of the pre-diabetic period in individuals with high risk of type 1 diabetes from the general population. Methods: High-risk children (n = 21) positive for multiple islet autoantibodies were identified by autoantibody screening within the All Babies in Southeast Sweden study. The children and their parents were enrolled in a 2-year prospective follow-up study aiming to characterize the pre-diabetic period. Blood samples were collected every 6 months for measurement of C-peptide, HbA1c, fasting glucose, and autoantibodies. Human leukocyte antigen-genotype was determined, and oral glucose tolerance test was performed every 12 months. Results: Despite positivity for multiple autoantibodies, 9 out of 21 individuals had low-risk human leukocyte antigen-genotypes. Children who progressed to manifest diabetes (progressors, n = 12) had higher levels of IA2A and ZnT8A than children who did not (non-progressors, n = 9). Impaired glucose tolerance and impaired fasting glucose was observed to the same extent in progressors and non-progressors, but HbA1c increased over time in progressors in spite of increased C-peptide. Conclusions: Autoantibodies to IA2 and ZnT8 may be useful discriminators for disease progression in at-risk children from the general population. Dysglycemia was observed long before diagnosis, and difficulties in maintaining glucose homeostasis despite increased C-peptide indicate that insulin resistance might be an important accelerator of disease in risk individuals.
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