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The Lancet. T1DM intensiv behandling förbättrar HbA1c hos CGM patienter. Svensk studie

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ARTICLESVolume 59101485December 2025
Open Access

Systematic intensive therapy in addition to continuous glucose monitoring in adults with type 1 diabetes: a multicentre, open-label, randomised controlled trial

 

 

Summary

Background

Although continuous glucose monitor/intermittent scanning continuous glucose monitor (CGM/isCGM) is widely used for glucose monitoring, many adults with type 1 diabetes (T1D) still fail to achieve recommended glycaemic targets.
We aimed to evaluate whether digital distance counselling based on CGM data could improve glycaemic control in adults with T1D and suboptimal control.

Methods

In this multicentre, open-label, randomised controlled trial, adults with T1D and HbA1c ≥58 mmol/mol, already using CGM/isCGM with insulin therapy (multiple daily injections or pump), were enrolled across eight sites in Sweden and Norway.
Participants were allocated (1:1) via a minimisation algorithm to receive either systematic intensive therapy (SIT) or conventional therapy (CT). The SIT group received weekly distance counselling, including CGM interpretation, if mean glucose was ≥8·4 mmol/L, during an 18-week intervention period. The control group attended two clinical visits during this period.
The primary outcome was change in HbA1c from baseline to 18 weeks. Adverse events of special interest (AESI; severe hypoglycaemia or diabetic ketoacidosis) were assessed in the safety population.
This trial is registered at clinicaltrials.gov number NCT03474393.

Findings

117 participants were enrolled and randomised (59 SIT, 58 control). At 18 weeks, mean (SD) HbA1c decreased by −10·7 (9·4) mmol/mol (−0·98% [0·86]) in the SIT group compared with −2·4 (8·4) mmol/mol (−0·22% [0·77]) in CT, resulting in an adjusted mean difference of −8·3 mmol/mol (95% CI −11·2 to −5·5), equivalent to −0·76% (95% CI −1·02 to −0·50%; P < 0·0001).
No AESI were observed in the SIT group, compared with one event in the control group (1·7%), giving a risk difference of −1·7% (95% CI −5·1 to 1·6%).

Interpretation

SIT improves glycaemic control in adults with T1D using CGM/isCGM who are not achieving recommended glycaemic targets, without evidence of safety concerns.
These findings highlight the critical role of structured, individualised interventions in addressing persistent glycaemic management deficits and advancing clinical outcomes in this population.

Funding

The study was supported by the Swedish state, Region Västra Götaland, and the Swedish Diabetes Foundation.

Evidence before this study

We searched PubMed up to December 2017 and conducted an updated search after trial completion, covering publications up to February 2025, using the terms “telemedicine”, “CGM”, “type 1 diabetes”, and “glycaemic control” in different combinations. Evidence from the available literature showed that CGM and isCGM improved glycaemic control, but many individuals still did not reach the recommended glycaemic targets. A lack of RCTs was noted regarding the efficacy and safety of glucose management by telemedicine for adults with type 1 diabetes

Added value of this study

In this randomised controlled trial of 117 adults, it was found that systematic intensive therapy with distance counselling improved HbA1c by 10·7 mmol/mol (0·98%) compared to 2·4 mmol/mol (0·22%) for the control group after 18 weeks.
Furthermore, there was significant improvement in time in range, mean glucose, and time above range. There was no increase in hypoglycaemia or ketoacidosis during systematic intensive therapy.

Implications of all the available evidence

This study shows that systematic intensive therapy is an effective and safe method to improve glycaemic control for adults with type 1 diabetes already using CGM/isCGM, without increasing the risk of hypoglycaemia or ketoacidosis.
From the article

Introduction

Treatments for persons with type 1 diabetes (T1D) have changed rapidly over the past decades, with continuous glucose monitoring (CGM) and insulin pumps being used more often.1 The DIAMOND and GOLD trials demonstrated that CGM reduces HbA1c by 5–7 mmol/mol (0·4–0·6%), decreases hypoglycaemia, and improves well-being in adults using multiple daily insulin injections.2,3 Insulin pumps have similarly been shown to lower HbA1c and increase time in range.4Despite these advances, many individuals with T1D also in high-income countries like Sweden where CGM is standard care, fail to achieve the recommended HbA1c targets, leaving them at risk of serious diabetes complications.5 This raises a critical question: How can diabetes care teams further support individuals with T1D in achieving optimal glycaemic control?
The American Diabetes Association (ADA) emphasises a person-centred approach in diabetes management, advocating for healthcare teams to facilitate individualised self-care strategies.6 Telehealth or telemedicine, endorsed by the ADA as complements to traditional clinical visits,7 have shown promise in improving glycaemic control and quality of life, as evidenced by observational studies.8–10 By enabling real-time interpretation of CGM data in the context of daily life, telemedicine reduces the time-burden for patients and fosters more timely, tailored interventions.
In low- and middle-income countries, where CGM adoption is growing but remains limited to a minority due to constrained healthcare resources,11 distance counselling offers significant potential.
Digital support can bridge gaps in care by providing remote guidance, optimising the use of scarce resources, and improving logistics. However, randomised controlled trials are needed to evaluate the impact of telehealth and distance counselling on glycaemic outcomes, patient experience, and safety as integral components of T1D management
The primary aim of this study was to evaluate whether digital support and closer collaboration with a diabetes nurse, focusing on CGM data interpretation, could improve glycaemic control in adults with T1D and suboptimal control. Additional exploratory objectives were to examine whether the intervention could alleviate diabetes-related distress and to evaluate the safety of the treatment.
From the Discussion
In conclusion, this randomised trial provides evidence that systematic intensive therapy with distance counselling based on CGM data significantly improves glycaemic control in adults with T1D, with no evidence of harm.
The intervention was also associated with greater treatment satisfaction and reduced diabetes-related distress, underscoring its potential value in clinical care.
The approach offers more direct and frequent feedback for everyday diabetes management, benefitting those who may find it challenging or stressful to attend in-person clinical visits.
Additionally, it holds significant potential in settings with limited healthcare resources, addressing barriers to care and supporting equitable access to effective diabetes management
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Hälsolyft med telemedicin vid diabetes typ 1

Personer med diabetes typ 1 fick avsevärt bättre långtidsblodsocker när deras värden följdes av vården i realtid,

via en sensor under huden, och de fick regelbunden rådgivning i sin vardag. Det visar en studie vid Göteborgs universitet.

Arndís Ólafsdóttir Doktorand, diabetessjuksköterska
Marcus Lind Professor/överläkare

 

Det kan vara en tuff utmaning att balansera sin insulinbehandling vid diabetes typ 1 och ligga så nära ett normalt glukosvärde som möjligt. Samtidigt är det viktigt för att minimera riskerna för både akuta tillstånd och långsiktiga komplikationer och skador.

Många vuxna patienter i västvärlden har så kallad kontinuerlig glukosmätning. Men även när de får sina glukossvärden i realtid, via smartphone eller separat mottagare, är det vanligt att blodsockervärdena inte håller sig inom givna målområden.

– Diabetes typ 1 kräver mycket av patienten, och ingen dag är den andra lik. Sov du bra? Hur stressad är du? Sprang du till bussen? Har du varit sjuk? Man måste vara redo att reagera på många saker hela tiden, utan paus, och folk blir trötta på det, konstaterar Arndís Ólafsdóttir, doktorand på Sahlgrenska akademin vid Göteborgs universitet, diabetessjuksköterska och en av de ledande bakom studien.

 

Sensoravläsning och vardagssupport
I studien, publicerad i The Lancet Regional Health – Europe, prövades en systematisk och intensiv behandling med distansövervakning av glukosvärden och vårdkontakt varje vecka. Alla deltagare hade haft kontinuerlig glukosmätning i minst tre månader innan studien började.

Blodsockervärden lästes av via en sensor under huden ungefär var femte minut och skickades till sjukhuset varje vecka. Om värdena inte låg på nivåer förenliga med låg risk för organskador läste diabetessjuksköterska av värdena på distans och tog kontakt för rådgivning och samtal om vad som hänt i närtid i patientens dagliga liv.

 

– När vi ringde berättade vi vad vi såg, frågade vad de behövde hjälp med, diskuterade vad som varit svårt och hur de försökt lösa det. Problemen var ofta kopplade till insulindosering, kost eller hur mycket de rört sig. Samtalen kunde också komma in på hur man gör om man ska gå ut med kollegor efter jobbet, om man ska gå på fest, allt möjligt, berättar Arndís Ólafsdóttir.

 

Behandlingen pågick under 18 veckor. Av totalt 117 deltagare hade 59 lottats till den intensiva behandlingen medan 58 utgjorde kontrollgrupp och gavs konventionell behandling med två vårdbesök under perioden. Deltagarna kom från sju sjukvårdsområden i Sverige samt Oslo.

 

Säkerhet och användningsområden
Efter 18 veckor hade långtidsblodsockret hos intensivgruppen sjunkit med drygt 8 mmol/mol mer än i kontrollgruppen, vilket utgör en kraftig förbättring, nästan tre gånger så stor som den förbättring på 3 mmol/mol i långtidssocker som anses skydda organ i kroppen.

Nöjdheten i intensivgruppen var större och behandlingen visade sig vara säker då inga allvarliga händelser med lågt socker och medvetslöshet eller så kallad syraförgiftning ägde rum, medan ett fall skedde i kontrollgruppen.

– Detta är också en mycket viktig aspekt i studien då det trots allt är stor skillnad att en patient exempelvis gör justeringar i en insulinpump på distans med rådgivning jämfört med att individen får fysisk vägledning på plats på sjukhus, säger Arndís Ólafsdóttir.

 

Studien kan potentiellt ge stor nytta också i andra delar av världen, konstaterar Marcus Lind, professor i diabetologi vid Göteborgs universitet, och huvudansvarig i studien.

– För många individer med typ 1-diabetes i olika delar av världen kan man ha långt till sjukhus eller så föreligger bristande resurser. Att effektiv rådgivning kan ske på distans med sensortransferering i realtid av blodsockervärden och insulinjusteringar kan därför komma många till del, säger han.

Studie:

Systematic intensive therapy in addition to continuous glucose monitoring in adults with type 1 diabetes: a multicentre, open-label, randomised controlled trial

Margareta G. Kubista Kommunikatör press release Gbgs Universitet
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