Background and Aims

Enabling connectivity in historically non-connected diabetic devices (such as injector pens) requires developers to understand and mitigate usability risks. Developers can utilize the user research and user experience (UX) design processes to inform design decisions which can influence user adoption, intended use, and adherence.

Methods

Researchers performed inductive analysis of findings from a sample of user research efforts which occurred between 2014 and 2019 at Novo Nordisk A/S. These findings were compared against findings from secondary research of publications focusing on user experience in medical device development.

Results

This analysis generated themes user needs and expectations which can be used to inform design and development decisions for future generations of connected diabetes devices and services.

Conclusions

Themes in usability risks and user experiences expectations could inform the creation of more successful medical interventions for people with diabetes. Medical developers should consider these findings when planning and executing new product development (NPD) efforts.

Background and Aims

Nation-wide flash or intermittently-scanned continuous glucose monitoring (isCGM) was introduced in Belgium in 2016. We investigated whether diabetes knowledge/health literacy would impact glucose control after one year of isCGM use in adults with type 1 diabetes (T1D).

Methods

We conducted a prospective real-world cohort study. Diabetes literacy was assessed using a new 10-item questionnaire (Patient Education And Knowledge (PEAK)). Health literacy was assessed using the validated 6-item Newest-Vital Sign-D (NVS-D) questionnaire. Primary outcome measure was the association between PEAK score and change in HbA1c. Secondary outcome measures were the association between the NVS-D score and change in HbA1c, the link between time spent in/above/below range (TIR/TAR/TBR) and scores on the PEAK/NVS-D questionnaires.

Results

857 patients (age: 46±15y; diabetes duration: 24±14y; CSII users: 21%; hypo-unaware: 21%) were consecutively recruited between July 2016 and June 2018. Median PEAK score was 8 (range: 1-10) and NVS-D score was 6 (range 0-6). Individuals with the lowest scores (0-6) on the PEAK questionnaire had comparable changes in Hba1c as those with highest scores (9-10) (baseline: 7.89±1.24%, 1y: 7.83±1.05% vs baseline: 7.85±1.45%, 1y: 7.68±0.97% respectively). Furthermore, no between-group differences were observed regarding TIR/TAR/TBR. Similarly, we found no association between score on the NVS-D questionnaire and evolution of Hba1c/TIR/TAR/TBR.

Conclusions

In this large cohort of well-educated adults with T1D no associations between diabetes/health literacy and glucose control after one year of isCGM use were observed, probably due to the high baseline educational level.

Background and Aims

Parents of a child suffering type 1 diabetes report distress.It may diminish in intensity, but that it does not disappear entirely. AIM: to test the hypothesis that technology may be a source of parental distress.

Methods

We studied 49 T1 DM subject since the onset (Age 9,3 ± 3,9 M± SD) using Parenting Stress Index 4th ed. Parental Distress (PD)—how parents feel competent, conflicted, supported, depressed in their role. Parent-Child Dysfunctional Interaction (P-CDI)—how they feel satisfied with their child and their interactions. Difficult Child (DC)—How they perceive their child to be. DIF (Difficulty Identifying Feeling). We used a multivariate approach.

Results

At the onset of diabetes there is a high correlation between DIF and PDS score (r=0.97) as seen also in our reference population not using insulin pumps. CHO counting adoption did not change this interaction. Soon after combination of SAP + Counting mantains the correlation between DIF and PDS score (r=0.90) but between PCDI and DC score become stronger (r = 0.94) with respect to DIF and PDS score (r = 0.83).

Conclusions

Parents try to portray himself as competent (abnormal emotional stress of parenting), or do not invest in their role experiencing stress associated with child care. After the onset of T1 DM parents cannot effectively cope with sources of stress (reduced sense of parental competence, conflict with the other parent, lack of social support, presence of depression). High DIF means no defense and sincerity (not necessary to give a favorable image). It's time for sudden intervention by the multidisciplinary team.

Background and Aims

Effect of self-monitoring of blood glucose (SMBG) frequency on glycemic control in people with type 1 diabetes has been proven; less data are available on type 2 diabetes (T2DM) patients using insulin. Aim was to assess effect of group education and frequency of SMBG on glycemic control in elderly T2DM patients on insulin.

Methods

Multicentric structured group education project was performed in 14 diabetes outpatients in 2016-2017. Schedule included 4x2hrs of interactive education within 6 weeks in small groups (6-12 patients) focused on diabetes selfmanagement including SMBG. 120 elderly T2DM people on insulin were included [median 64yrs (67% over 60yrs), 53% of men, BMI 32.8±6.3kg/m², mean SMBG frequency 10.4±8.1/week]. Metabolic parameters, SMBG and satisfaction with project (anonymous questionnaire) were evaluated in 6 months.

Results

Mean HbA_1c was reduced significantly (67.6±16.1 at baseline vs. 60.8±13.0 mmol/mol in 6 months;p<0.001) and correlated negatively with structured SMBG weekly frequency both at baseline (r=-0.256, p<0.01) and in 6 months (r=-0.213, p<0.05). Patients´ satisfaction with the project was high and would be 100% re-attending. All participants highly appreciated interactive group discussion with individual experience sharing which they evaluated as important motivation in diabetes selfmanagement improvement.

Conclusions

Human factor of interpersonal interaction during group education with sharing experience of life with diabetes tends to be motivating factor for disease adherence improvement. Effect of group education and SMBG weekly frequency on amelioration of glycemic control in elderly T2DM patients on insulin was demostrated. It seems that such people could also profit from new glucose monitoring technologies that enables frequent selfmonitoring.

Background and Aims

Mobile health applications and mobile devices are widely available for the treatment of type 1 diabetes mellitus (insulin dependent) (TD1). They enable real-time monitoring and recording of blood glucose measurements, enabling the diagnosis and management of chronic conditions outside the hospital environment. The digital data produced can be shared with healthcare providers, researchers, and social media. However, there are legal and ethical challenges to these emerging technologies for healthcare professionals, focusing mainly on the management of childhood and adolescent diabetes using insulin pumps and continuous glucose recordings. There is also an increasing number of people using 'DIY' improvised diabetes management technology that is not certified and experimentally manufactured by people with TD1 or parents of children with TD1 at their own risk.

Methods

All of these challenges are analyzed through hypothetical realistic scenarios, reflecting the experiences of healthcare professionals taking care of children and adolescents with TD1.

Results

Security is a serious problem if a person with TD1 (or parent or family member) chooses to set up a DIY system. Should he or she continue to receive support and care from the health professional and the health system? The emergence of DIY technologies raises concerns, including forensic risks and issues related to recording and medical practice.

Conclusions

It is argued that current ethical approaches can be effectively applied in defining the duties of healthcare professionals using new technologies, recognizing the change in the nature of the doctor-patient relationship and the perception of therapeutic benefits.

Background and Aims

PEPPER (Patient Empowerment through Predictive PERsonalised decision support) is an EU-funded research project which aims to improve self-management of type 1 diabetes (T1D). The system comprises an AI insulin bolus recommender, coupled with a safety system. The aim of the qualitative arm of this clinical feasibility study was to examine the context of participants’ interaction with the PEPPER system and identify incidents where bolus recommendations were trusted and accepted.

Methods

This was a multicentre (UK and Spain) non-randomised open-labelled 6-week pilot study. Thirteen adults with T1D participated in weekly telephone interviews to explore the context of their interactions and responses to PEPPER. Data was thematically analysed through conceptual frameworks for engagement with healthcare digital behaviour change interventions.

Results

Participants reported their key interactions as responding to PEPPER bolus recommendations, inputting carbohydrate values, interpreting continuous glucose monitoring (CGM) values through visualization of personal data and dealing with safety alarms. Two themes were associated with trust and engagement with the system; ‘feeling monitored’ and ‘feeling in control’. The incidents where participants trusted PEPPER also enhanced personal expertise of T1D through insights provided by the safety system such as low glucose basal insulin for pump users. Benefits were balanced against technical challenges of the system, which were used to improve the PEPPER application and enhance user experience.

Conclusions

Some participants suggested that even access to PEPPER for a temporary period could positively influence self-management strategies. Contextual interviewing is a valuable tool in mobile application development for diabetes decision support systems.

Background and Aims

Adolescents with T1D rely on the support of their parents and the transition of responsibility during adolescence is often difficult. Only a small percentage of adolescents meet HbA1c standards. We aim to create a system that uses automated, data-driven weekly reports to improve the management of T1D for adolescents in part through improving diabetes-specific communication.

Methods

We are recruiting 40 dyads of adolescents with T1D and their parents in a 3-month randomized clinical trial. A weekly diabetes management report is generated using an algorithm that synthesizes insulin, activity, and CGM data to provide glucose management information and depict patterns of glycemic risk. The CloudConnect report also provides suggestions about diabetes management and weekly achievements. During the study, participants share CGM values in real-time with their parents. We assessed a validated score of reported diabetes-related conflict (Diabetes Family Conflict Scale, DFCS) before and after the intervention.

Results

Of the 10 dyads that have completed the study, 6 (4 male adolescents, mean age = 16.7 (±1.2 yrs.)) were randomized to use CloudConnect. Whereas family conflict typically worsens over adolescence, our data show that the participants using CloudConnect have a tendency for improvement in DFCS over the course of the study. The experimental group had an initial mean DFCS of 27.11 (±5.09) out of 57, which reduced to 26.56 (±4.36) by the end of the study.

Conclusions

CloudConnect may highlight areas of improvement for adolescents with T1D and reduce family conflict.

Background and Aims

Vitamin D deficiency has been reported in several autoimmune conditions The role of autoimmune gastritis in the pathogenesis of nutritional deficiencies has been revealed, therefore we assumed a possible association between gastric parietal cells autoantibodies (PCA) and 25(OH)D deficiencyin T1D patients.The aim of this study was to evaluate the prevalence of 25(OH)D deficiency in patients with T1D and Vitamin D status association with PCA.

Methods

78 T1D patients (42 females; mean age 43.5 ± 12.8 years) were followed-up in Endocrinology research Centre from November 2018 to May 2019. 25(OH)D, parathormone, calcium, PCA measured in all T1D patients. We also evaluated autoantibodies to glutamic acid decarboxylase (GAD), islet antigen 2 (IA2) and zinc transporter isoform-8 (Znt8) to confirm the autoimmune genesis of diabetes.The results were compared with a control group of 42 healthy subjects.

Results

In T1D group (n=78) 25(OH)D levels were significantly lower than in the control group 14,6 [9,1;23,0] vs 27,0 [22,1; 34,7] ng/ml, p < 0,0001.

29 out of 78 patients with T1D were positive to PCA.Vitamin D values in these groups were 17,3 [9.9 23.6] and 12 ,4 [7,1;23,0] respectively.

Only 3 out of 42 patients (7%) were positive to PCA in control group without autoimmune diseases.

Conclusions

Data from the present study showed a significant reduction of 25(OH)D levels in T1D patients. No difference in Vitamin D status was found in patients with and without PCA. Possible impairment of vitamin D absorption in autoimmune gastritis may be caused by mucosal atrophy which may appear years after PCA start to be detectable in blood.

Background and Aims

Pulsatile Insulin Treatment (PIT) is characterized by once weekly i.v. low dose insulin pulses (10-12 pulses/h) over a period of 2-3 h. The frequent changes of insulin levels are considered to sensitize insulin receptors in metabolism and vasculature. We have initiated a prospective clinical trial to confirm positive results regarding improvement of kidney function and metabolic insulin sensitivity published from previous investigations.

Methods

48 patients will be enrolled in this 3-month trial and will receive PIT once weekly for 2h-3h. Blood glucose will be kept in a range between 80 mg/dL to 180 mg/dL by means of additional blood glucose infusions and oral glucose uptake (if necessary). Glucose is measured every 10 min using a CGM sensor and additional invasive reference readings.

Results

First patients undergoing the modified PIT protocol have reacted by

(A) increasing i.v. glucose requirements in the course of the first treatment session (e.g. patient 1: 4.5 g/h in the first 120 min and 12 g/h in the following 60 min) and

(B) by substantially elevated i.v. glucose requirements in the following treatment session one week later (same patient: 32 g/h in the first 120 min and 53 g/h in the following 60 min). This pattern of increase in insulin sensitivity was seen in all patients treated so far.

Conclusions

If these preliminary findings will be confirmed by the overall study results and renal function can indeed be preserved, PIT has the potential to become a treatment option for treatment of secondary complications in patients with long-term diabetes.