Perceptions of diabetes distress during pregnancy in women with type 1 and type 2 diabetes: a qualitative interpretive description study.

BACKGROUND: Diabetes distress is commonly seen in adults with pre-existing diabetes and is associated with worsened glycemic management and self-management practices. While a majority of women report increased stress during pregnancy, it is unknown how women with type 1 or type 2 diabetes experience diabetes distress during this unique and transitional time. PURPOSE: This study aimed to understand the experiences and perceptions of diabetes distress in women with pre-existing diabetes during pregnancy. METHODS: A qualitative study using an interpretive description approach was conducted. In-depth, one to one interviewing was used to capture rich descriptions of the pregnancy experience. Nested, stratified, and theoretical sampling was used to recruit 18 participants with type 1 and type 2 diabetes from the quantitative strand of this mixed methods study. Constant comparative analysis was used to inductively analyze the data and develop themes. FINDINGS: Four themes, each with several subthemes, emerged under the main finding of "Diabetes Distress": 1) Worry for Baby's Health - "What's this going to do to the baby?"' 2) Feeling Overwhelmed with Diabetes Management-"It just seemed unattainable"; 3) Living with Diabetes - "There's no way out" and 4) Cycle of Diabetes Distress. CONCLUSIONS: The findings from this study identify the sources and experiences of diabetes distress during pregnancy in women with pre-existing diabetes. Diabetes distress often presents as cyclical and multifaceted during pregnancy, with elements of fear for the unborn baby, difficulties with diabetes management, and having negative lived experiences of diabetes. Further work is needed to develop appropriate screening tools for pregnancy and interventions to mitigate diabetes distress. Diabetes educators are well-positioned provide emotional support and person-centred self-management education to individuals with diabetes.

The Examination and Exploration of Diabetes Distress in Pre-existing Diabetes in Pregnancy: A Mixed-methods Study.

OBJECTIVES: Diabetes distress (DD) has been understudied in the pregnancy population. Pregnancy is known to be a complex, highly stressful time for women with diabetes because of medical risks and the high burden of diabetes management. Our aim in this study was to explain and understand DD in women with pre-existing diabetes in pregnancy. METHODS: An explanatory, sequential mixed-methods study was undertaken. The first strand consisted of a cross-sectional study of 76 women with type 1 and type 2 diabetes. A nested sampling approach was used to re-recruit 18 women back into the second strand for qualitative interviews using an interpretive description approach. RESULTS: DD was measured by the validated Problem Area in Diabetes (PAID) scale. A PAID score of ≥40 was positive for distress. DD prevalence was 22.4% in the cross-sectional cohort and the average PAID score was 27.75 (standard deviation 16.08). In the qualitative strand, women with a range of PAID scores (10.0 to 60.0) were sampled for interviews. The majority of these participants described themes of DD in their interviews. Of the 15 women who described DD thematically, only 6 had positive PAID scores. CONCLUSIONS: Integration of the mixed-methods data underscores important meta-inferences about DD in pregnancy, namely that DD was present to a greater degree than the PAID tool is sensitive to. DD was present qualitatively in most of the qualitative sample, despite interviewing women with a range of PAID scores. Future research on a pregnancy-specific DD scale is needed.

How to Design a Qualitative Health Research Study. Part 1: Design and Purposeful Sampling Considerations.

In this first part of the article, we aim to provide health researchers with an understanding of how to design a qualitative health research study, including: topic identification, design selection, and engagement in reflexivity. We offer practical guidance for writing an overarching question using a novel framework that helps develop a clearly articulated question that includes the following elements: emphasis, purposeful sampling, phenomenon of interest, and context. We then expand on specific methodological issues: study designs, contexts, sampling, and recruitment. Finally, we provide examples of qualitative health research studies that illustrate the application of different research designs. In part two of this article, we will discuss how to prepare for going into the field, how to generate, manage and analyse data, and plan for the dissemination of qualitative health research.

Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes.

CONTEXT: The added benefit of glucagon in artificial pancreas systems for overnight glucose control in type 1 diabetes has not been fully explored. OBJECTIVE: The objective of the study was to compare the efficacy of dual-hormone (insulin and glucagon) artificial pancreas, single-hormone (insulin alone) artificial pancreas, and conventional insulin pump therapy. DESIGN: This study was a three-center, three-arm, open-label, randomized, crossover controlled trial involving three interventions, each applied over a night after a high carbohydrate/high fat meal and a second after exercise to mimic real-life glycemic excursions. SETTING: The study was conducted in a home setting. PATIENTS: Twenty-eight type 1 diabetes participants (21 adults and seven adolescents) participated in the study. INTERVENTIONS: Dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional pump therapy was activated from 9:00 PM to 7:00 AM. MAIN OUTCOME: The main outcome was a proportion of time in target (4-8 mmol/L) by continuous glucose monitoring from 11:00 PM to 7:00 AM. Analysis was by intention to treat. RESULTS: The median (interquartile range) percentage of time-in-target glucose range was 47% (36%-71%) for conventional therapy, higher on both single-hormone (76% [65%-91%], P < .001) and dual-hormone artificial pancreas (81 [68%-93%], P < .001). The median (interquartile range) time spent below 4 mmol/L was 14% (4%-28%) for conventional therapy, lower on both single-hormone (5% [0%-13%], P = .004) and dual-hormone artificial pancreas (1% [0%-8%], P < .001). There were 14 hypoglycemic events on conventional therapy compared with six incidences on the single-hormone artificial pancreas (P = .059) and three incidences on the dual-hormone artificial pancreas (P = .017). None of these outcomes differed significantly between single- and dual-hormone configurations. CONCLUSIONS: Single- and dual-hormone artificial pancreas systems both provided better glucose control than conventional therapy. Although the dual-hormone configuration did not increase overnight time-in-target glucose levels, an effect on lowering hypoglycemia risk cannot be ruled out.

Diurnal Glycemic Patterns during an 8-Week Open-Label Proof-of-Concept Trial of Empagliflozin in Type 1 Diabetes.

BACKGROUND: We recently reported improved glycemic control with reduced insulin dose in subjects with type 1 diabetes treated with the sodium glucose co-transporter-2 inhibitor empagliflozin. To further characterize the effects, we analyzed diurnal glycemic patterns by continuous glucose monitoring (CGM). METHODS: In an 8-week single-arm open-label pilot study of empagliflozin, we compared ambulatory glucose profiles produced from CGM data during 2-week intervals in a placebo run-in baseline period, end-of-treatment, and post-treatment. Change in glycemic exposure was evaluated by area under the median curve according to time of day (AUCTOTAL 12:00am-11:55pm; AUCDAY 7:05am-10:55pm, AUCNIGHT 11:00pm-7:00am), as well as glycemic variability, glycemic stability and time-in-target (≥70 to ≤140mg/dL). RESULTS: The 40 patients (26 on insulin pump) were aged 24±5 years and BMI 24.5±3.2 kg/m2. Consistent with the observed HbA1c decrease (8.0±0.9% to 7.6±0.9%, p<0.0001), normalized AUCTOTAL CGM decreased from 153.7±25.4 to 149.0±30.2mg/dL∙h at end-of-treatment (p = 0.31), and significantly increased post-treatment (164.1±29.5mg/dL∙h, p = 0.02). The numerical decrease in normalized AUCNIGHT (152.0±36.6 to 141.9±34.4mg/dL∙h, p = 0.13) exceeded AUCDAY (154.5±24.5 to 152.6±30.4mg/dL∙h, p = 0.65). Trends toward lower glycemic variability (83.1±18.9 to 75.6±28.6mg/dL, p = 0.06) and little change in glycemic stability (10.8±3.6 to 10.3±4.5mg/dL/h, p = 0.51) were observed. When empagliflozin was discontinued, these worsened relative to baseline (89.3±19.3mg/dL, p = 0.04 and 11.8±3.7mg/dL/hr, p = 0.08). Time-in-target numerically increased (40.2±11.9 to 43.1±13.5%, p = 0.69) at end-of-treatment but reversed post-treatment. Findings were similar on stratification of pump and MDI subjects. CONCLUSIONS: We observed that empagliflozin was associated with patterns of improved nighttime glycemia more prominent than daytime. TRIAL REGISTRATION: Clinicaltrials.gov NCT01392560.

Evaluation of a clinical tool to test and adjust the programmed overnight basal profiles for insulin pump therapy: a pilot study.

OBJECTIVE: Clinical protocols for basal rate testing and adjustment are needed for effective insulin pump therapy. We evaluated the effects of a continuous glucose monitoring (CGM)-based semiautomated basal algorithm on glycemia. METHODS: We developed and piloted a basal rate analyzer that interpreted CGM data from overnight fasts and recommended dose changes for subsequent nights. Subjects uploaded data online using sensor-augmented pumps for evaluation by the analyzer after each of 5 overnight fasts conducted over 2 to 8 weeks. It was designed to be conservative and iterative, making changes that did not exceed 10% at each iteration. The standard deviation and interquartile range of CGM values from midnight to 7 am (SD12-7am and IQR12-7am) over 3 baseline and 3 postintervention nights, hypoglycemia incidence (CGM values <4.0 mmol/L), and glycated hemoglobin (A1C) were compared. RESULTS: Twenty subjects with mean ages of 38±13 years and A1C 7.6%±0.8% (60±8.7 mmol/mol) underwent the 5 iterations of basal assessments over 5±3 weeks. SD12-7am and IQR12-7am did not change from baseline to postintervention (1.57±0.8 to 1.63±0.8 mmol/L; p=0.35; 3.66±2.07 to 3.47±2.26 mmol/L; p=0.90). However, mean glucose values were lower between 2 to 3 am at baseline compared to postintervention; 3-night hypoglycemia incidence declined from 1.6±1.8 to 0.5±0.7 episodes (p=0.01), and A1C improved from 7.6%±0.8% to 7.4%±0.9% (60%±8.7% to 57%±9.8% mmol/mol; p=0.03). CONCLUSIONS: The use of a basal rate analyzer was associated with reduced hypoglycemia and improved A1C. However, overnight glycemic stability was not improved. Further research into the efficacy of the CGM-based semiautomated algorithm is warranted.

Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial.

OBJECTIVE: Adjunctive-to-insulin therapy with sodium-glucose cotransporter 2 (SGLT2) inhibition may improve glycemic control in type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: We evaluated the glycemic efficacy and safety of empagliflozin 25 mg daily in 40 patients treated for 8 weeks in a single-arm open-label proof-of-concept trial (NCT01392560). RESULTS: Mean A1C decreased from 8.0 ± 0.9% (64 ± 10 mmol/mol) to 7.6 ± 0.9% (60 ± 10 mmol/mol) (P < 0.0001), fasting glucose from 9.0 ± 4.3 to 7.0 ± 3.2 mmol/L (P = 0.008), symptomatic hypoglycemia (<3.0 mmol/L) from 0.12 to 0.04 events per patient per day (P = 0.0004), and daily insulin dose from 54.7 ± 20.4 to 45.8 ± 18.8 units/day (P < 0.0001). Mean urinary excretion of glucose increased from 19 ± 19 to 134 ± 61 g/day (P < 0.0001). Weight decreased from 72.6 ± 12.7 to 70.0 ± 12.3 kg (P < 0.0001), and waist circumference decreased from 82.9 ± 8.7 to 79.1 ± 8.0 cm (P < 0.0001). CONCLUSIONS: This proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T1D.