A trigger initiates an autoimmune attack on the beta cells of the pancreas through autoreactive T cells&nbsp;10

T1D is an autoimmune disease caused by an autoimmune response against pancreatic beta cells3

T1D is not primarily a metabolic disease; in T1D, the immune system&nbsp;attacks&nbsp;pancreatic beta cells,&nbsp;hindering their ability to produce insulin3

The body is&nbsp;no longer able to produce insulin&nbsp;once beta cells have been destroyed by the immune system3

Lack of production of insulin leads to&nbsp;hyperglycaemia3

A criticial deficiency of insulin causes&nbsp;DKA&nbsp;to occur8, a traumatic event which can have a lasting negative impact on brain function&nbsp;1,9

DKA,diabetic ketoacidosis; T1D, type 1 diabetes.

<h2>AUTOIMMUNE T1D CAN START LONG BEFORE SYMPTOMS ARISE1</h2>
The rate of autoimmune T1D progression varies significantly; it can take months to decades for symptoms to develop.1,6

70% of children with multiple autoantibodies progress to symptomatic autoimmune T1D within 10 years.*10

5-year risk&nbsp;of progressing to symptomatic autoimmune T1D (Stage 3)6:

From Stage 1

From Stage 2

The&nbsp;lifetime risk&nbsp;of progressing to symptomatic autoimmune T1D (Stage 3) from Stages 1 and 2 approaches&nbsp;100%.&nbsp;6

Screening can transform lives by detecting the condition before symptoms develop.6,8,9

IQR, interquartile range; T1D, type 1 diabetes. *In a pooled analysis of three prospective cohort studies including children from Colorado, Finland and Germany, progression to autoimmune T1D at 10-year follow-up after autoantibody seroconversion in 585 children with multiple autoantibodies was 69.7% (95% CI, 65.1%-74.3%).10

Autoimmune T1D is a progressive condition; the decline of beta cell function can begin months to years before symptoms appear.1,5,6
People with autoimmune T1D progress through three clinically distinct stages as their beta cells are progressively destroyed.4,6,7

The lifetime risk of progressing to symptomatic autoimmune T1D (Stage 3) from Stages 1 and 2 approaches&nbsp;100%.&nbsp;6

Screening can transform lives by detecting the condition before symptoms develop.6,8,9

T1D, type 1 diabetes. 
 *Reversion to single autoantibody or negative status can occur in some people with previously confirmed multiple autoantibody positivity.4

References

Understanding Autoimmune T1D disease & Different Stages

TYPE-1-DIABETES

DIABETES

INTEGRATED-DIABETES-CARE

Time-in-Range: A Key Determinant of Quality of Life

Tune in to Dr. Battelino’s enlightening talk on the profound impact of ‘Time in Range’ on the quality of life for diabetes patients. Gain valuable insights into how optimizing this crucial metric can significantly improve patient well-being and life satisfaction. A must-watch for all physicians striving for excellence in diabetes care.

The value of Time-in-range

Insights from Prof. Tadej Battelino on the value of Time-in-range as a Glycemic biomarker.

The Evolving Role of Treatment and Technology in Diabetes Care

Join Dr. Robert Rizzel as he navigates the transformative role of treatment and technology in diabetes care. This video provides a detailed overview of how these innovations are reshaping diabetes management, offering medical practitioners a deeper insight into contemporary diabetes care. Step into this enlightening journey to understand the future trajectory of diabetes treatment.

<h2>DKA IS A MEDICAL EMERGENCY ASSOCIATED WITH HIGH MORBIDITY3</h2>
Prevalence of DKA at diagnosis varies, but can be up to 70% across Europe and North America. DKA at diagnosis is often due to diagnostic error and treatment delay.3

DKA is responsible for approximately half of all hospitalisations in people with autoimmune T1D.29,30

DKA can have serious neurocognitive effects31; even a single severe episode has been shown to impair memory and IQ.*32

DKA is associated with a sustained negative effect on glycaemic control over time,†&nbsp;increasing morbidity and mortality.33

By approximately how much can screening and monitoring programmes reduce DKA rates?
DKA, diabetic ketoacidosis; FLUID, Fluid Therapies Under Investigation in Diabetic Ketoacidosis; IQ, intelligence quotient; PECARN, Pediatric Emergency Care Applied Research Network; T1D, type 1 diabetes. *In a prospective study including 758 children who presented with DKA in a randomised multisite clinical trial evaluating fluid protocols for DKA treatment (PECARN FLUID trial). DKA status was associated with lower scores in overall IQ, memory for item-colour associations and forward digit span recall.32&nbsp;†Independent of other variables.33

<h2>AVOIDING DKA AT DIAGNOSIS CAN IMPROVE HEALTH OUTCOMES1,41–44</h2>
Screening can facilitate prompt and effective glycaemic management, reducing the risk of severe macrovascular and microvascular complications.1,41–44
Avoiding DKA at diagnosis is associated with better long-term HbA1c levels.7,33

Preventing chronic hyperglycaemia can help reduce the risk of:

including stroke and cardiovascular disease

MACROVASCULAR COMPLICATIONS45

including eye, kidney and nervous system

MICROVASCULAR COMPLICATIONS45

An average of up to ~18 life-years lost in those diagnosed before age 10

A REDUCED LIFE EXPECTANCY*†46

Of ~40% of adults with autoimmune T1D initially misdiagnosed,&nbsp;77% were misdiagnosed with T2D‡; this can delay proper insulin replacement therapy, prolong hyperglycaemia and increase the risk of DKA.20
CI, confidence interval; DKA, diabetic ketoacidosis; HbA1c, haemoglobin A1c; T1D, type 1 diabetes; US, United States. *Compared to matched controls, according to a nationwide, register-based cohort study including 27,195 individuals with autoimmune T1D in Sweden, using data from the Swedish National Diabetes Register46&nbsp;†Men diagnosed with autoimmune T1D before 10 years of age lost a median of 14.2 life-years (95% CI 12.1, 18.2). Females diagnosed at the same age lost a median of 17.7 life-years (95% CI 14.5, 20.4). People diagnosed after 20 years of age lost approximately 10 life-years.46&nbsp;‡In a retrospective online survey of people with autoimmune T1D and caregivers of people with autoimmune T1D in the US, a diagnosis of autoimmune T1D was missed in 38.6% of those diagnosed at ≥18 years of age. Of those people, 76.8% were initially diagnosed with type 2 diabetes.20

The burden of Autoimmune T1D

<h2>Beyond HbA1C, It is time to think Time-in-Range</h2>
Optimizing Time-in-range is fundamental to effective Diabetes management and to help reduce the risk of the negative consequences for your patients1-5

Each&nbsp;1‌0‌% drop in Time-in-Range (TIR)&nbsp;was associated with increased frequency of

<h4 style="text-align: center;">Retinopathy2*</h4>
<img alt="" src="/dam/jcr:b196a16d-2dec-4c07-a138-242cc1bf3cc0/encadres-1.png">

<h4 style="text-align: center;">Microalbuminuria2*</h4>
<h4><img alt="" src="/dam/jcr:6f5f7f10-64e8-48c5-aa14-2dd071b9d7fb/encadres-2.png"></h4>

<h4 style="text-align: center;">Neuropathy3†</h4>
<img alt="" src="/dam/jcr:72b8750b-f8cc-4d4f-b6a4-ad32a7c56277/encadres-3.png">

<h4 style="text-align: center;">Mortality4☨</h4>
<img alt="" src="/dam/jcr:73077044-5ded-40bc-ac02-3cabb06f421a/encadres-4.png">

More TIR was associated with reduced&nbsp;risk of severe hypoglycemia, MACE and microvascular complications&nbsp;vs&nbsp;less TIR5#&nbsp;

In people with T2DM
Risk of a severe hypoglycemia event decreased by up to:

<div>
 <table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="text-align: center;">Time-in-range is an important physical and emotional measure of success for people with T1DM and T2DM6,7</td>
 </tr>
 </tbody>
 </table>
 Up to 5‌7‌% of people with T1‌DM and T2‌DM ranked TIR as the measurable therapy outcome that had the biggest impact on daily life with diabetes6†† Up to 5‌4‌% ranked TIR as the highest driver of a positive mindset6‡‡&nbsp;
</div>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="text-align: center;">ADA and the International Consensus on TIR&nbsp;recommend reducing glycemic variability and&nbsp;optimizing TIR&nbsp;as a key aspect of effective diabetes management in people with T1DM and T2DM&nbsp;8,9</td>
 </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="text-align: center;">Optimizing HbA1c to &lt;7‌.0‌%8,10&nbsp;and reducing glycemic variability: 
 TIR&gt;7‌0‌% and %CV≤3‌6‌%8,10&nbsp;helps achieve better patient outcomes2,4,5,7,8</td>
 </tr>
 </tbody>
</table>

*Post hoc analysis using the DCCT dataset to evaluate the association of TIR of 7‌0‌–1‌8‌0‌ mg/dL (3‌.9‌–1‌0‌ mmol/L) with the development or progression of retinopathy and microalbuminuria to validate TIR as a metric. Criteria for the retinopathy outcome were met by n=2‌7‌1‌/1‌,4‌4‌0‌ (1‌9‌%), and for the microalbuminuria outcome were met by n=1‌1‌6‌/1‌,2‌8‌3‌ (9‌%). Mean TIR for 7‌-point profiles for 1‌,4‌4‌0‌ people was 4‌1‌ ± 1‌6‌%. Adjusted HR (9‌5‌% CI) for retinopathy: 1‌.6‌4‌ (1‌.5‌1‌ to 1‌.7‌8‌); adjusted HR (9‌5‌% CI) for microalbuminuria: 1‌.4‌0‌ (1‌.2‌5‌ to 1‌.5‌6‌). From discrete Cox proportional hazards regression models using a time-dependent version of each glucose metric stratified by the ETDRS level of retinopathy at baseline and adjusted for the pre-DCCT glycemic exposure represented by the pre-existing duration of diabetes separately for the primary and secondary cohorts; p&lt;0‌.0‌0‌1‌.2

†&nbsp;Data from a prospective observational cohort study which evaluated the association of TIR of 7‌0‌–1‌8‌0‌ mg/dL (3‌.9‌–1‌0‌ mmol/L) with microvascular diabetes outcomes, including peripheral neuropathy; 6‌2‌ out of 1‌0‌5‌ participants with a total MNSI questionnaire score ≥2‌ were defined as having distal peripheral neuropathy, including 5‌1‌ with CKD and 1‌1‌ controls; CKD patients defined as having eGFR &lt;6‌0‌mL/min/1‌.7‌3‌m2. Odds ratio (9‌5‌% CI): 1‌.2‌5‌ (1‌.0‌2‌ to 1‌.5‌2‌). Adjusted for age, sex and race.3

‡&nbsp;A prospective cohort study (N=6‌,2‌2‌5‌) evaluating the link between TIR of 7‌0‌–1‌8‌0‌ mg/dL (3‌.9‌–1‌0‌ mmol/L) with all-cause and cardiovascular mortality, with the objective of validating TIR as surrogate marker of long-term adverse clinical outcomes. Adjusted HR (9‌5‌% CI) for all-cause mortality: 1‌.0‌8‌ (1‌.0‌5‌ to 1‌.1‌2‌); adjusted HR (9‌5‌% CI) for CV mortality: 1‌.0‌5‌ (1‌.0‌0‌ to 1‌.1‌1‌). From restricted cubic spline nested in time-dependent Cox model. Adjusted for age, sex, smoking, diabetes duration, BMI, systolic blood pressure, triglycerides, HDL cholesterol, LDL cholesterol, history of cancer, history of CVD, and using antihypertensive drugs, aspirin, and statins.4

#Post hoc study using data from the devote&nbsp;study from 5‌,6‌4‌4‌ people with T2‌DM who had an 8‌-point glucose profile. Individual TIR was derived as the proportion of the 8‌-point glucose profile within range (derived TIR). A Cox model was used to estimate the association between derived TIR and time to first MACE, severe hypoglycaemic episode and microvascular event (retinopathy and CKD). HRs (9‌5‌% CI) for MACE: 0‌.6‌9‌ (0‌.5‌2‌ to 0‌.9‌1‌) for TIR&gt;7‌0‌% vs TIR ≤5‌0‌%; 0‌.9‌1‌ (0‌.6‌6‌ to 1‌.2‌4‌) for TIR &gt;7‌0‌% vs TIR &gt;5‌0‌–≤7‌0‌% (overall association p&lt;0‌.0‌1‌). HR (9‌5‌% CI) for microvascular event: 0‌.6‌0‌ (0‌.4‌3‌ to 0‌.8‌5‌) for TIR&gt;7‌0‌% vs TIR ≤5‌0‌%; 0‌.7‌3‌ (0‌.4‌9‌ to 1‌.0‌9‌) for TIR &gt;7‌0‌% vs TIR &gt;5‌0‌–≤7‌0‌% (overall association p&lt;0‌.0‌1‌9‌). Hazard ratios were consistent when analyses were adjusted for baseline characteristics.5

**TIR &gt;7‌0‌% vs ≤5‌0‌%. HR (9‌5‌% CI) vs TIR ≤5‌0‌% for time to first severe hypoglycemia: 0‌.5‌4‌ (0‌.4‌0‌ to 0‌.7‌3‌).5

††Online survey of 3‌,4‌6‌1‌ people with T1‌DM (n=1‌,0‌2‌6‌) or T2‌DM (n=1‌,1‌5‌4‌ on insulin; n=1‌,2‌8‌1‌ not on insulin). The survey presented respondents with 2‌5‌ questions investigating patients’ perceptions of the success of current diabetes drugs and devices; which factors have the biggest impact on patients’ daily lives and which changes would have the biggest positive impact on diabetes management and mindset; and mental well-being, QoL, desired improvements for future therapies, relationships with health care providers, and the concerns of loved ones. The survey was conducted from 1‌7‌–2‌2‌ August.6

‡‡Food choices were rated by all groups (range 6‌3‌% to 6‌7‌% of the groups) as the greatest factor having an impact on daily life with diabetes, but TIR emerged as the measurable therapy outcome that had the biggest impact on daily life with diabetes for all groups of respondents (range 4‌1‌% to 5‌7‌%).6

##Including intra-day mean glucose, glycemic variability, and glucose levels after meals and overnight. Based on a multicentre, randomised, crossover trial in adults with T1‌DM (n=8‌2‌) and T2‌DM (n=3‌0‌6‌). Participants received basal-bolus regimen of insulin glargine plus premeal insulin glulisine (n=1‌9‌2‌) or premix analogue insulin (n=1‌9‌6‌). Participants were then crossed over to the other treatment at 1‌2‌ weeks and continued for another 1‌2‌ weeks.7

Abbreviations

Impact of Time-In-Range on Diabetes Management

Real-World Study on Effectiveness of InsulinGlargine U300 After Oral Antidiabetic Drug Failure in Patients with Type 2 Diabetes in the Gulf Region

<h2>Introduction</h2>
Recent updates from the American Diabetes Association (ADA 2022) guidelines recommend basal insulin with OAD treatment for individuals with T2D post-oral therapy failure
The ATOS study, a global observational, real-world study, aimed to evaluate the effectiveness and safety of Gla-300 in Asia, the Middle East, North Africa, Latin America, and Eastern Europe
This chapter presents data from Gulf countries - Kuwait, Saudi Arabia, and the UAE - aiming to analyze regional variations in diabetes management. The focus on the Gulf region enhances the significance of the findings, considering differences in healthcare systems and patient support resources

<h2>Objective</h2>
To evaluate the real-world effectiveness and safety of Gla-300 in participants with T2D after OAD drug failure in people with T2D in the gulf region

<h2>Study Design</h2>
412 individuals with T2D from 3 countries&nbsp;

Insulin-naïve ≥18 years old participants included were:
Having uncontrolled HbA1c
<ul>
 <li>HbA1c &gt;7% and ≤11% on ≥1 OAD</li>
 <li>in whom the treating physicians had decided, in accordance with the local guidelines, to add Gla-300 to the treatment</li>
</ul>

<table align="center" border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(122, 0, 230); border-color: rgb(122, 0, 230);">Gla-300 once daily (N = 412)</td>
 </tr>
 </tbody>
</table>

<ul>
 <li>The Mean ± SD at baseline for age was 52.2 ± 11.1, for duration of T2DM was 10.7 ± 6.8 years, and for HbA1c % it was 9.2 ± 1.1</li>
 <li>Around 50% of participants were on a non-T2D medication (n=208); ([CV conditions (n=197) and blood-related conditions (n=51)])</li>
</ul>

<h2>Study Endpoints</h2>
<h3>Primary Endpoint</h3>

Percentage of participants achieving predefined individualized HbA1c goal at Month 6

Change from baseline in HbA1c, FPG, SMPG, and body weight at Month 6 and 12

Percentage of participants achieving their pre-defined individualized HbA1c&nbsp;target at Month 3 and 12

Hypoglycemic events reported during the study

DTSQs Score, EQ-5D VAS score, EQ-5D TTO score, and perceived frequency of hypo and hyperglycemia

<h2>Efficacy Outcomes</h2>
<ul>
 <li>The proportion of participants achieving HbA1c target increased over the study duration, with over 75% of participants reaching HbA1c &lt;8% at the end of the study</li>
 <li>The drop HbA1c from baseline to each of the data points (month 3, 6 and 12) was consistent and significant with tight 95% CI</li>
</ul>

<div>
 <table align="center" border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(122, 0, 230); border-color: rgb(122, 0, 230);">Proportion of participants achieving HbA1c target achievement</td>
 </tr>
 </tbody>
 </table>
</div>

<div>
 <table align="center" border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td style="text-align: center; background-color: rgb(122, 0, 230); border-color: rgb(122, 0, 230);">Levels of HbA1c in participants from Month 3 to 12</td>
 </tr>
 </tbody>
 </table>
</div>

The primary endpoint of achieving individually set HbA1c target (average of 6.9% ± 0.4%) by Month 6 of treatment with Gla-300 was achieved in 57 participants [13.8% with 95% CI (10.6; 17.6)]
At month 6, the individualized HbA1ctargets showed correlation with geographical location of participants i.e., participants from rural area had lower odds of meeting the target compared to urban dwellers (suburban: OR = 0.492; 95% CI [0.063; 3.864] Vs rural areas: OR = 0.656; 95% CI [0.192; 2.240])
In comparison to baseline HbA1c of 7–8% the baseline HbA1c ≥10% was associated with a lower likelihood of achieving HbA1c target at Month 6.&nbsp;i.e., baseline HbA1c 8–9%: [OR = 0.839; 95% CI (0.352; 1.995)], baseline HbA1c 9–10%: [OR = 0.665; 95% CI (0.272; 1.625)], baseline HbA1c ≥10%: [OR = 0.523; 95% CI (0.205; 1.336)]
A greater number of co-morbid conditions reduced the likelihood of achieving the HbA1c target by half [OR = 0.508; 95% CI 0.111; 2.332)]. Moreover, age beyond 75 years was associated with approximately 49% lower likelihood of achieving the primary endpoint (P = 0.138) (may be due to the small group size).
Other parameters analysed, including BMI, comorbidities, prior OAD use, and health insurance status, showed trends in impacting HbA1c target achievement, however these trends were not statistically significant
<h2>Other parameters analyzed</h2>
<ul>
 <li>Employment status of individuals significantly modified likelihood of HbA1c target achievement at Month 6 (P = 0.021)</li>
 <li>Compared to full-time employees or students, retired individuals (n = 35) were 2.893 times more likely to achieve HbA1c target(P = 0.016)</li>
 <li>Individuals with unknown occupation status (n = 21) had 3.857-fold higher odds of achieving the primary endpoint of the study (P = 0.007)</li>
</ul>
<h2>Safety Outcomes</h2>
<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(122, 0, 230);">Adverse Events</td>
 <td style="text-align: center; background-color: rgb(122, 0, 230);">GLA 300 
 (N = 412)</td>
 </tr>
 <tr>
 <td>Any AE over 6 months&nbsp;&nbsp; &nbsp;</td>
 <td style="text-align: center;">4 (1%)</td>
 </tr>
 <tr>
 <td>Any AE over 12 months</td>
 <td style="text-align: center;">4 (1%)</td>
 </tr>
 <tr>
 <td>Any SAE</td>
 <td style="text-align: center;">(0.2%)</td>
 </tr>
 <tr>
 <td>Any TEAE</td>
 <td style="text-align: center;">(1.0%)</td>
 </tr>
 <tr>
 <td>Any hypoglycemia, without instances of severe hypoglycemia&nbsp;&nbsp; &nbsp;</td>
 <td style="text-align: center;">3 (0.7)</td>
 </tr>
 <tr>
 <td>Any TEAE leading to treatment discontinuation&nbsp;&nbsp; &nbsp;</td>
 <td style="text-align: center;">(0.5%)</td>
 </tr>
 <tr>
 <td>Any TEAE leading to death</td>
 <td style="text-align: center;">0</td>
 </tr>
 </tbody>
</table>

<h2>Conclusion</h2>
In real-life setting in Gulf region, initiation of Gla-300 in insulin-naïve people with T2D uncontrolled on OADs resulted in improved glycaemic control with low rates of reported and perceived hypoglycemia and increasingly improved PROs throughout the study duration; reflecting treatment satisfaction and better health status
<h3>Abbreviations</h3>
AE, adverse event;BMI, body mass index; CI, confidence interval; CV, cardiovascular; DTSQ, diabetes treatment satisfaction questionnaire; EQ-5D VAS, EuroQol 5-dimension scale visual analogue scale; EQ-5D TTO, EuroQol 5-dimension scale time trade-off; FPG, fasting plasma glucose; GI, gastrointestinal; Gla-300, insulin glargine 300 U/mL; HbA1c, glycated haemoglobin; OAD, oral antidiabetic drug; OR, odds ratio; PROs, patients reported outcomes; SD, standard deviation; SMBG, self-monitored blood glucose; SAE, serious adverse events; T2D, type 2 diabetes TEAEs, treatment-emergent AEs.

Reference

The ATOS Study: Real-World Study on Effectiveness of Insulin Glargine U300 in the Gulf Region.

TYPE-2-DIABETES

SoliD: Redefine Treatment Paradigm Post-OAD

Get a sneak peek into the groundbreaking clinical data on iGlarLixi, unveiled at the American Diabetes Association’s 84th Scientific Sessions. This teaser video introduces a 24-week randomized controlled trial that explores the effectiveness of iGlarLixi in managing Type 2 diabetes. Without revealing too much, we can promise interesting findings on blood glucose control and hypoglycemia risk. Stay tuned for a deep dive into the trial’s results and their implications for diabetes treatment. Don’t miss out on this exciting revelation in the world of diabetes research.

SoliCGM Synergy: Soliqua’s Synchronized Impact on T2DM CGM Dynamics Therapy

Join Dr. Viral Shah as he explores the use of CGM metrics to assess clinical outcomes in Type 2 Diabetes patients receiving Iglarlixi. This insightful discussion sheds light on the transformative role of Soliqua in diabetes management, providing valuable perspectives for healthcare professionals. Enhance your knowledge and improve patient care with this engaging talk.

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