Background and Aims

To understand whether subcutaneous mini-dose glucagon (MDG) is an effective treatment for fasting-induced hypoglycemia in people with type 1 diabetes using real-time CGM (rt-CGM) and fasting during Ramadan.

Methods

A randomized, controlled crossover trial involving 17 participants with type 1 diabetes while they were fasting during Ramadan. All participants received rt-CGM and were randomized to either 150-mg, 300mg subcutaneous glucagon (MDG) or oral glucose tablets (OG) to treat fasting induced hypoglycemia with a crossover after. A participant feedback questionnaire was developed and used.

Results

MDG users had higher mean and maximum rt-CGM glucose concentrations one hour after treatment of hypoglycemic episodes as compared to those given OG (mean 76 vs 67 mg/dL, maximum 108 vs 86 mg/dL; p< 0.05). Events that were treated with MDG showed an increase in time between 70-180mg/dL (42% vs 33%; p <0.45 ) with less time <54mg/dL (14% vs 33%;p <0.55) and less time <70mg/dL (50% vs 67%; p <0.29). 65% of participants using MDG avoided mild hypoglycemia or late evening hypoglycemia corrections and therefore avoided breaking their fasts. 94% of the participants prefer to use MDG over oral options for correcting fasting induced hypoglycemia as MDG treatment can avoid breaking a fast.

Conclusions

MDG administration is more effective and preferable to carbohydrate consumption for preventing and treating fasting-induced hypoglycemia in people with type 1 diabetes during Ramadan. MDG can reduce the burden of breaking a fast in addition to avoidance of the negative experience of hypoglycemia itself.

Background and Aims

Within the Greek funded project, named “ENDORSE”, an innovative integrated platform is developed harnessing the power of Artificial Intelligence, sensing and gamification technologies, facilitating self-disease management in children with Type 1 Diabetes Mellitus (T1DM) while supporting decision making in formal and informal caregivers. A two phase pilot randomized trial is foreseen to evaluate its effectiveness.

Methods

Particular use cases based on the applied insulin treatment are defined involving children 6-16 years old. Taking into consideration the current clinical methods for managing T1DM in Greece along with the necessary approvals from the national ethical committee, a clinical protocol is drafted specifying, amongst others, inclusion/exclusion criteria (e.g. diabetes duration>1 year, without celiac disease, without complications) and monitored parameters.

Results

Following a training phase, the participants receive hardware (e.g. Insulclock devices and activity trackers) and software modules to use them for 3 months during their daily habits while performing monthly screening visits to the “Agia Sofia” Children’s Hospital. In Phase 1 pilot, 30 patients are recruited. This phase represents a feasibility study to implement the technical equipment into patient care and to collect new data for improving the ENDORSE recommendation engine. In Phase 2 pilot, 70 patients are recruited and randomly assigned (2/3:1/3) into an intervention and a control group.

Conclusions

The ENDORSE pilot trial tests the feasibility of implementing advanced ICT technologies into routine clinical care of T1DM children while improving patients’ satisfaction and clinical outcomes. Acknowledgements: Supported within the framework of the ENDORSE project, which is funded by the NSRF (Grant agreement: Τ1ΕΔΚ-03695)

Background and Aims

Environmental factors/stresses play an imperative part in pathophysiology of Obesity and Type 2 diabetes mellitus (T2DM). This pilot study aimed to assess the effect of life style intervention on the degree of methyaltion of Chemerin, Insulin induced gene 2, Pro-opiomelanocortin genes and advanced glycation end products in metabolic healthy and unhealthy subjects.

Methods

Fifty eight subjects between the ages of 20-38 years were recruited from Aga Khan University and categorized as metabolically healthy (Group A n=28) and metabolically unhealthy (Group B n=30) using NCEP-II criteria. Group B subjects were provided a 6 months intervention where they refrained from consuming all forms of processed food, maintained a daily food/calorie diary and performed physical activity for at least 30 minutes each day of the week. Fasting blood glucose, Insulin, Lipid profile, Serum Chemerin, and AGE levels were measure. Methylation specific PCR was performed for Chemerin, POMC and INSIG-2 at both time intervals.

Results

At baseline, serum AGE was elevated in Group B subjects vs Group A (878.611 ± 20.85Vs. 410.19 ± 36.52ng/ml). High methylation potential was seen for genes regulating insulin release and satiety i.e. INSIG 2, POMC while high degree of nonmethylation was seen in Chemerin in Group B compared to Group A. At 6^th month reduction in AGE levels (756 ± 14.55ng/ml) along with 3% reduction in degree of Chemerin nonmethylation was observed.

Conclusions

Preliminary data suggests that these changes can be modified with dietary intervention and life style modification.

Background and Aims

Gestational diabetes diagnosis has been challenging during the Covid-19 pandemic. We assessed the feasibility of a novel home-based OGTT using continuous glucose monitoring (CGM) to identify hyperglycemia in pregnancy.

Methods

Women with a singleton pregnancy at 28 weeks’ gestation with ≥1 risk factor for gestational diabetes attending antenatal glucose testing were recruited to a pilot single-centre prospective observational study. A Dexcom G6 continuous glucose monitoring sensor was sited (masked) and women were asked to take a 75g OGTT solution (Rapilose) on day 4 after a 10 hour overnight fast. Qualitative interviews were performed with 20 participants using telephone or video conferencing using a pre-determined interview schedule and thematically analysed using NVIVO software.

Results

Forty-six women completed a home OGTT with 7.4 days of CGM. 40/46 (87.0%) took the glucose solution as instructed, and 16 (34.8%) had CGM glucose readings at 0, 60 and 120 minutes which met WHO criteria for gestational diabetes diagnosis. These women had evidence of hyperglycemia on other CGM metrics: increased mean CGM glucose (106 vs 92 mg/dl (5.9 vs 5.1 mmol); p<0.001) and time-above-range (≥140 mg/dl; ≥7.8 mmol/l; 6.8 vs 2.0%; p=0.006). Time-in-range was not significantly different. Women found the CGM painless, convenient and reassuring to use. All 20 women interviewed would recommend CGM with a home OGTT for diagnosis of gestational diabetes.

Conclusions

A home-based antenatal OGTT using CGM is feasible and acceptable to pregnant women and identifies women with hyperglycemia in pregnancy. Home OGTTs using CGM may improve testing capacity during the Covid-19 pandemic.

Background and Aims

In addition to the challenges that the COVID-19 pandemic has brought on the global population, people with diabetes (PWD) may face even greater complications. In this study, we investigated glycemic outcomes of PWDs before and after shelter-in-place orders in the US and EMEA, to better understand the impact of the pandemic on PWDs’ diabetes management.

Methods

We randomly selected 12179 users of a diabetes management app who uploaded data from a CGM (“CGM users”), and 7986 who uploaded data from a blood glucose (BG) meter and/or insulin pump (“non-CGM users”). We compared glucose, insulin, and physical activity data before and after March 2020.

Results

We compared glycemic outcomes 3 weeks prior to and 3 weeks post mid-March 2020 in the USA.

Pre-March, PWDs had worse glycemic outcomes during weekends compared to weekdays. Post March, we found that this trend disappeared.

For CGM users (median age=28years(IQR12-45), 53% female, 92% T1D), the average BG decreased from a median of 166.4mg/dL to 164.6 mg/dL post March. The mean TIR increased from 62.3% to 63.3%. The %time >180 mg/dL decreased from 35.3% to 34.3%.

For non-CGM users (median age=64 years(IQR 49-72), 46% female, 45% T1D), the average BG decreased from 169.2mg/dL to 167.5 mg/dL.

Finally, we observed a lower daily steps count, from a median of 3709 steps/day to 2762 steps/day.

Conclusions

The present analysis indicates that on average, PWDs experienced slightly improved glycemic outcomes along with fewer glucose fluctuations during weekends in the weeks immediately following shelter-in-place orders. This was accompanied by an overall lowered physical activity.

Background and Aims

Uncontrolled glycemia is recognised as a critical factor in prognosis of Covid-19. Hospitalised patients have several challenges in frequently monitoring glucose and adjusting dosages in addition to inevitable fear of PPE suits and impending death. Our patients are used to virtual consultations via DTMS^® which has been in vogue since 1997.

Methods

For consenting patients diagnosed of Covid-19, we offer 'virtual Covid IP care' with 24/7 support, care and advices from a team of 3 doctors, 4 nurses, 2 diabetes educators and 2 dietitians. Risk assessment is carried out online using a questionnaire and is assigned to the Virtual IP follow up team(VIT). The care is coordinated through a dedicated WhatsApp group of patient and caretaker where a doctor and nurse is assignd duty 24/7. The VIT follows up with the patient to assess parameters such as body temperature,BG, BP, SpO2 and general well-being every 3-6 hrs. The patient should have usual self-monitoring devices with them for remote monitoring. Various technologies such as Libre, Guardian Connect, Apple Watch,connected glucose meters etc. are used in selected patients. Sample collection for essential lab investigations(CBC,LFT,RFT,CRP,D-Dimer,Ferritin, LDH etc.) are arranged at home.

Results

127 diabetes patients affected with Covid-19 availed of the virtual IP facility. Virtually managing BG round the clock was the top priority. In patients on dexamethasone, CGM was made mandatory. 2 patients were hospitalised. All patients recovered.

Conclusions

With predictions of similar pandemics in future, virtual IP concept needs to be studied further and popularised to prevent overwhelming hospitals and inaccesibility to critical care.

Background and Aims

In early 2020, due to Covid-19, telehealth was used to deliver care. Data on the use of telehealth by age groups in adults with type 1 diabetes (T1D) is not known.

Methods

EHR data of adults with T1D were analyzed for visit frequency and type: in-person vs. video (VV) vs. phone (PV) between March through August in both 2019 and 2020. The months of 2020 were divided: period 1: March through May when telehealth was mostly PV, and period 2, June through August, when telehealth was offered as both VV and PV. We stratified data by age: adults (age 40-64 yrs) and older adults (≥65 yrs).

Results

Data from 2,762 adults with T1D were assessed. In 2019 vs. 2020, 3,565. vs. 3,882 clinic visits occurred. In both years, 69% of patients were adults and 30% were older adults.

The number of telehealth visits by PV and VV increased by > 1000% from 2019 vs 2020 (PV: 0 vs. 2,241; VV: 14 vs. 1,236; P<0.001).

In period 1 of 2020, PV vs. VV in adults was 81% vs. 6% (P<0.001) and in older adults was 84% vs. 5% (P<0.001). In period 2, PV vs. VV in adults was 27% vs. 65% (P<0.001) and in older adults was 36% vs. 55%. The overall number of VV was greater in the adults vs older adults, 65% vs. 55% (P=0.001).

Conclusions

During Covid-19 pandemic, telehealth use increased dramatically, initially as PV, and subsequently, as VV. Older adults were more likely to use PV compared to adults.

Background and Aims

Methods

Results

Conclusions