SummaryBackgroundPregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes.MethodsIn this multicentre, open-label, randomised controlled trial, we recruited women aged 18–40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527.FindingsBetween March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference −0·19%; 95% CI −0·34 to −0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most...

OBJECTIVEHypoglycemia unawareness (HU) affects ∼25% of people with type 1 diabetes. People with HU are often reliant on family to detect hypoglycemia and treat severe episodes. We explored the impact of HU on family members' lives, their involvement in preventing and managing hypoglycemia, and their information and support needs. RESEARCH DESIGN AND METHODSThis study employed an exploratory, qualitative design comprising in-depth interviews with 24 adult family members of persons with type 1 diabetes and HU. RESULTSFamily members described restricting their lives so that they could help the person with HU detect and treat hypoglycemia. Some described being very physically afraid of their partner/relative when they had a hypoglycemic episode due to their aggressive and argumentative behavior and personality changes; this could also make treatment administration difficult. Family members also reported feeling anxious and worried about the safety of the person with HU, particularly when they were left unsupervised. These concerns were often precipitated by traumatic events, such as discovering the person with HU in a coma. Family members could neglect their own health and well-being to care for the person with HU and resentment could build up over time. Family members highlighted extensive, unmet needs for information and emotional support; however, some struggled to recognize and accept their own need for help. CONCLUSIONSOur findings reveal a caregiver group currently "in the shadow of the patient" and in urgent need of information and emotional support. Raising awareness among health care professionals is essential, and developing proactive support for family should be considered.

BackgroundGestational diabetes mellitus (GDM) is an increasingly common condition of pregnancy. It is associated with adverse fetal, infant and maternal outcomes, as well as an increased risk of GDM in future pregnancies and type 2 diabetes for both mother and offspring. Previous studies have shown that GDM can result in an emotionally distressing pregnancy, but there is little research on the patient experience of GDM care, especially of a demographically diverse UK population. The aim of this research was to explore the experiences of GDM and GDM care for a group of women attending a large diabetes pregnancy unit in southeast London, UK, in order to improve care.MethodsFramework analysis was used to support an integrated analysis of data from six focus groups with 35 women and semi-structured interviews with 15 women, held in 2015. Participants were purposively sampled and were representative of the population being studied in terms of ethnicity, age, deprivation score and body mass index (BMI).ResultsWe identified seven themes: the disrupted pregnancy, projected anxiety, reproductive asceticism, women as baby machines, perceived stigma, lack of shared understanding and postpartum abandonment. These themes highlight the often distressing experience of GDM. While most women were grateful for the intensive support they received during pregnancy, the costs to their personal autonomy were high. Women described feeling valued solely as a means to produce a healthy infant, and felt chastised if they failed to adhere to the behaviours required to achieve this. This sometimes had an enduring impact to the potential detriment of women’s long-term psychological and physical health.ConclusionsThis study reveals the experiences of a demographically diverse group of patients with GDM, reflecting findings from previous studies globally and extending analysis to the context of improving care. Healthcare delivery may need to be reoriented to improve the pregnancy experience and help ensure women are engaged and attentive to their own health, particularly after birth, without compromising clinical pregnancy outcomes. Areas for consideration in GDM healthcare include: improved management of emotional responses to GDM; a more motivational approach; rethinking the medicalisation of care; and improved postpartum care.Electronic supplementary materialThe online version of this article (10.1186/s12884-018-1657-9) contains supplementary material, which is available to authorized users.

A qualitative analysis of patient interviews identified deficits in education, technology and motivation in hypoglycaemia unawareness. Interventions can therefore be tailored to target underlying problems that prevent individual patients from regaining awareness. A brief assessment tool was devised to categorize patients' hypoglycaemia unawareness accordingly. Psychological interventions should be developed to address the problems of 'low concern' regarding hypoglycaemia unawareness.

Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed. A mixed-method analysis of the barriers to and facilitators of successful diabetes self-management, a health economic analysis, a cluster randomised controlled trial of different models of delivery of an educational intervention and the potential of insulin pumps and additional educator input to improve outcomes

Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE) ABSTRACT ObjeCtive To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. PartiCiPantsAdults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections.interventiOns Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main OutCOMe MeasuresThe primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was −0.85% with pump treatment and −0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was −0.24% (−2.7 mmol/mol) in favour of pump users (95% confidence interval −0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. COnClusiOnsBoth groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined. trial registratiOn Current Controlled Trials ISRCTN61215213.

OBJECTIVE To develop and pilot a novel intervention addressing motivational and cognitive barriers to avoiding hypoglycemia in people with type 1 diabetes and persistent impaired awareness of hypoglycemia (IAH) despite training in flexible insulin therapy. RESEARCH DESIGN AND METHODS A 6-week intervention using motivational interviewing and cognitive behavioral techniques was designed. Diabetes educators were trained and supported in its delivery to 23 people with IAH (Gold score ‡4). RESULTS Twelve months postcourse, hypoglycemia awareness had improved (P < 0.001). Median (range) rates of severe hypoglycemia (SH) fell from 3 (0-104) to 0 (0-3) per person per year (P < 0.0001) and moderate from 14 (0-100) to 0 (0-18) per person per 6 weeks (P < 0.001). Worry and behavior around hyperglycemia improved. HbA 1c was unchanged. CONCLUSIONS A pilot intervention targeting motivation and cognitions around hypoglycemia engaged patients with resistant IAH and recurrent SH and was associated with significant improvement, supporting the hypothesis that these factors underpin problematic hypoglycemia. Hypoglycemia and fear of hypoglycemia remain major barriers to achieving optimal glucose control and quality of life for people with type 1 diabetes. Structured education in flexible insulin therapy (e.g., the U.K.'s Dose Adjustment for Normal Eating [DAFNE]) and/or use of insulin pump therapy reduces severe hypoglycemia (SH) (1), but some continue to experience impaired awareness of hypoglycemia (IAH) with high rates of SH, their problematic hypoglycemia resistant to intervention. We hypothesized that many such people have motivational and cognitive barriers to hypoglycemia avoidance and resolution of IAH. We designed and piloted an intervention using motivational interviewing and cognitive behavioral theory targeting these barriers.

This study identified some common drivers that may regulate the health behaviours of women following GDM, and recognized some ways to improve care to impact on this. Interventions for diabetes prevention in this population need to address factors at both the individual and systemic levels.