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result(s) for
"Glycemic control"
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Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes
by
Thankamony, Ajay
,
Hovorka, Roman
,
Boughton, Charlotte K
in
Adverse events
,
Age groups
,
Algorithms
2022
In a multicenter, randomized, crossover trial involving children 1 to 7 years of age with type 1 diabetes, a closed-loop system was compared with sensor-augmented pump therapy in random order. The closed-loop system improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in a hypoglycemic state.
Journal Article
Tight Blood-Glucose Control without Early Parenteral Nutrition in the ICU
2023
In this randomized, controlled trial involving critically ill patients not receiving early parenteral nutrition, tight glucose control did not affect the length of time that ICU care was needed or mortality.
Journal Article
Clinical Impact of Personalized Physician’s Education and Remote Feedback Via a Digital Platform on Glycemic Control: Pilot Randomized Controlled Trial
2025
The digital education platform Doctorvice (iKooB Inc.) offers face-to-face physician-patient education during outpatient clinic visits, remote glucose monitoring, and the delivery of educational messages, and is expected to be effective for personalized diabetes care.
This study aims to evaluate the effectiveness of the digital education platform for diabetes care by comparing cases that included both face-to-face education and remote monitoring with those that included only face-to-face education.
This was a randomized clinical study conducted at the Diabetes Center of Seoul St. Mary's Hospital. Participants were aged ≥19 years and had glycated hemoglobin (HbA
) levels between 7.5% and 9.5%. In the intervention group, physicians used the digital education platform to provide face-to-face education at enrollment and at the 3- and 6-month visits, along with remote monitoring during the first 3 months of the 6-month study period. The control group received conventional outpatient education. Both groups completed questionnaires-assessing satisfaction with diabetes treatment, diabetes-related stress, and adherence to diabetes medication-at the beginning and end of the study. The primary endpoint was the change in HbA
levels.
A total of 66 participants were enrolled between August 1, 2022, and August 31, 2023. Of these, 26 in the intervention group and 30 in the control group were analyzed, excluding 10 participants who dropped out of the study. The mean baseline HbA
levels were 8.3% (SD 0.6%) in the intervention group and 8.0% (SD 0.5%) in the control group. At the 3-month follow-up, mean HbA
decreased by 0.5%-7.8% (SD 0.9%; P=.01) in the intervention group and by 0.2%-7.8% (SD 0.7%) in the control group. HbA
levels substantially improved during the first 3 months with both face-to-face education and remote glucose monitoring. However, HbA
tended to increase during the 3- to 6-month follow-up in the intervention group without the remote monitoring service. Satisfaction with diabetes treatment significantly improved at the end of the study compared with baseline in the intervention group (mean change +3.6 points; P=.006). Medication adherence improved in both groups, with no significant difference at 6 months (P=.59), although the intervention group showed a greater increase from baseline. Subgroup analysis indicated that the reduction in HbA
was greater for patients with baseline HbA
levels ≥8.0%, those aged ≥65 years, smokers, drinkers, and those with obesity in the intervention group.
The digital education platform for personalized diabetes management may be beneficial for glycemic control in type 2 diabetes mellitus. Its effectiveness appears to be enhanced when physicians provide personalized face-to-face education combined with remote feedback.
Clinical Research Information Service (CRiS) of Republic of Korea KCT0007953; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=23507&search_page=L.
Journal Article
Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes
2025
Orforglipron is a small-molecule, nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist in clinical development for type 2 diabetes and weight management. Additional data on the efficacy and safety of orforglipron are needed.
In this phase 3, double-blind, placebo-controlled trial, we randomly assigned participants in a 1:1:1:1 ratio to receive orforglipron at one of three doses (3 mg, 12 mg, or 36 mg) or placebo once daily for 40 weeks. Participants had type 2 diabetes treated only with diet and exercise, a glycated hemoglobin level of at least 7.0% but no more than 9.5%, and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 23.0. The primary end point was the change from baseline to week 40 in the glycated hemoglobin level. A key secondary end point was the percent change in body weight from baseline to week 40.
A total of 559 participants underwent randomization. The mean glycated hemoglobin level at baseline was 8.0%. At week 40, the estimated mean change from baseline in the glycated hemoglobin level was -1.24 percentage points with the 3-mg dose, -1.47 percentage points with the 12-mg dose, -1.48 percentage points with the 36-mg dose, and -0.41 percentage points with placebo. All three doses of orforglipron were superior to placebo with respect to the primary end point; the estimated mean difference from placebo was -0.83 percentage points (95% confidence interval [CI], -1.10 to -0.56) with the 3-mg dose, -1.06 percentage points (95% CI, -1.33 to -0.79) with the 12-mg dose, and -1.07 percentage points (95% CI, -1.33 to -0.81) with the 36-mg dose (P<0.001 for all comparisons). The mean glycated hemoglobin level at week 40 was 6.5 to 6.7% with orforglipron. The percent change in body weight from baseline to week 40 was -4.5% with the 3-mg dose, -5.8% with the 12-mg dose, -7.6% with the 36-mg dose, and -1.7% with placebo. The most common adverse events were mild-to-moderate gastrointestinal events, most of which occurred during dose escalation. No episodes of severe hypoglycemia were reported. Permanent discontinuation of orforglipron or placebo due to adverse events occurred in 4.4 to 7.8% of participants receiving orforglipron and 1.4% of participants receiving placebo.
In adults with early type 2 diabetes, orforglipron significantly reduced the glycated hemoglobin level over a period of 40 weeks. (Supported by Eli Lilly; ACHIEVE-1 ClinicalTrials.gov number, NCT05971940.).
Journal Article
Post-trial monitoring of a randomised controlled trial of intensive glycaemic control in type 2 diabetes extended from 10 years to 24 years (UKPDS 91)
by
Whiteley, William N
,
Adler, Amanda I
,
Holman, Rury R
in
Adult
,
Aged
,
Blood Glucose - analysis
2024
The 20-year UK Prospective Diabetes Study showed major clinical benefits for people with newly diagnosed type 2 diabetes randomly allocated to intensive glycaemic control with sulfonylurea or insulin therapy or metformin therapy, compared with conventional glycaemic control. 10-year post-trial follow-up identified enduring and emerging glycaemic and metformin legacy treatment effects. We aimed to determine whether these effects would wane by extending follow-up for another 14 years.
5102 patients enrolled between 1977 and 1991, of whom 4209 (82·5%) participants were originally randomly allocated to receive either intensive glycaemic control (sulfonylurea or insulin, or if overweight, metformin) or conventional glycaemic control (primarily diet). At the end of the 20-year interventional trial, 3277 surviving participants entered a 10-year post-trial monitoring period, which ran until Sept 30, 2007. Eligible participants for this study were all surviving participants at the end of the 10-year post-trial monitoring period. An extended follow-up of these participants was done by linking them to their routinely collected National Health Service (NHS) data for another 14 years. Clinical outcomes were derived from records of deaths, hospital admissions, outpatient visits, and accident and emergency unit attendances. We examined seven prespecified aggregate clinical outcomes (ie, any diabetes-related endpoint, diabetes-related death, death from any cause, myocardial infarction, stroke, peripheral vascular disease, and microvascular disease) by the randomised glycaemic control strategy on an intention-to-treat basis using Kaplan–Meier time-to-event and log-rank analyses. This study is registered with the ISRCTN registry, number ISRCTN75451837.
Between Oct 1, 2007, and Sept 30, 2021, 1489 (97·6%) of 1525 participants could be linked to routinely collected NHS administrative data. Their mean age at baseline was 50·2 years (SD 8·0), and 41·3% were female. The mean age of those still alive as of Sept 30, 2021, was 79·9 years (SD 8·0). Individual follow-up from baseline ranged from 0 to 42 years, median 17·5 years (IQR 12·3–26·8). Overall follow-up increased by 21%, from 66 972 to 80 724 person-years. For up to 24 years after trial end, the glycaemic and metformin legacy effects showed no sign of waning. Early intensive glycaemic control with sulfonylurea or insulin therapy, compared with conventional glycaemic control, showed overall relative risk reductions of 10% (95% CI 2–17; p=0·015) for death from any cause, 17% (6–26; p=0·002) for myocardial infarction, and 26% (14–36; p<0·0001) for microvascular disease. Corresponding absolute risk reductions were 2·7%, 3·3%, and 3·5%, respectively. Early intensive glycaemic control with metformin therapy, compared with conventional glycaemic control, showed overall relative risk reductions of 20% (95% CI 5–32; p=0·010) for death from any cause and 31% (12–46; p=0·003) for myocardial infarction. Corresponding absolute risk reductions were 4·9% and 6·2%, respectively. No significant risk reductions during or after the trial for stroke or peripheral vascular disease were observed for both intensive glycaemic control groups, and no significant risk reduction for microvascular disease was observed for metformin therapy.
Early intensive glycaemic control with sulfonylurea or insulin, or with metformin, compared with conventional glycaemic control, appears to confer a near-lifelong reduced risk of death and myocardial infarction. Achieving near normoglycaemia immediately following diagnosis might be essential to minimise the lifetime risk of diabetes-related complications to the greatest extent possible.
University of Oxford Nuffield Department of Population Health Pump Priming.
Journal Article
Joint effect of nicotine use and diabetes distress on glycemic control in young adults with type 1 diabetes
2025
Nicotine inhibits glucose metabolism. In this national cross-sectional analysis of 388 young adults with type 1 diabetes and above target glycemic control, vaping was the most common route of nicotine use, and heavy nicotine use plus higher type 1 diabetes distress was related to worse objective measures of glycemic control.
Trial registration: ClinicalTrials.govNCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473.
•Young adults with type 1 diabetes and high HbA1c are a vulnerable population.•One in four young adults with type 1 diabetes reported nicotine use in past month.•Young adults with type 1 diabetes primarily reported only nicotine vaping.•Higher nicotine use was significantly associated with worse glycemic control.•Heavy nicotine use plus higher diabetes distress related to worse glycemic control.
Journal Article
Community-Based Intelligent Blood Glucose Management for Older Adults With Type 2 Diabetes Based on the Health Belief Model: Randomized Controlled Trial
by
Zhang, Anqi
,
Yang, Shuang
,
Wang, Jinsong
in
Aged
,
Aged, 80 and over
,
Blood Glucose - analysis
2025
The number of older patients with type 2 diabetes (T2D) is increasing, and effective self-management is crucial for controlling disease progression and its complications.
We designed a home telemedicine intervention that combines telemedicine with health education based on the Health Belief Model (HBM). This study evaluated its effectiveness on self-management in older patients with T2D.
Between March and April 2022, we recruited 198 community-dwelling patients with T2D aged 65 years and older. Patients were randomly assigned to either a control group, which received a conventional diabetes management program, or an intervention group, which received a home telemedicine intervention with a health education program based on the HBM. The intervention lasted 6 months. The primary outcome measured was glycosylated hemoglobin (HbA1c); secondary outcomes included diabetes self-management capacity, self-efficacy, and health beliefs. We collected outcome metrics at baseline, 3 months, and 6 months. Generalized estimating equations were used to compare changes in outcomes.
A total of 96.5% (191/198) of patients completed the study. From baseline to 6 months, HbA1c decreased by mean -0.99% (95% CI -1.60% to -0.60%) in the intervention group and mean -0.42% (95% CI -0.90% to 0.90%) in the control group. The intervention group experienced a significantly greater reduction of 0.42% compared to the control group (95% CI 0.12%-0.73%). Furthermore, compared to the control group, the intervention group showed significant improvements in diabetes self-management skills (mean 5.88, 95% CI 4.98-6.79), self-efficacy (mean 9.40, 95% CI 8.15-10.66), and health beliefs (mean 19.54, 95% CI 17.71-21.36) at both 3 and 6 months.
Home telemedicine interventions incorporating health education based on the HBM can provide significant benefits for community-dwelling older patients with T2D, potentially offering new avenues for chronic disease prevention and management. However, future large-scale studies are required to further assess their effectiveness and feasibility.
Journal Article
Effect of stress management based self-care counseling on glycemic control in women with gestational diabetes mellitus: a randomized controlled trial study
by
Nikbakht, Hossein-Ali
,
Faramarzi, Mahbobeh
,
Nasiri-Amiri, Fatemeh
in
Adult
,
Anxiety
,
Blood Glucose - analysis
2025
Background
Stress plays an important role in the consequences of gestational diabetes mellitus [GDM]. It is possible to make a change in the lifestyle by providing counseling in the field of self-care based on stress management in order to avoid the adverse consequences of GDM. Therefore, the present study was designed and implemented with the aim of determining the effect of self-care counseling based on stress management on blood sugar control in women with GDM.
Methods
A randomized trial with two parallel arms was conducted involving 75 pregnant women diagnosed with GDM at 20–30 weeks of gestation, who were referred to Shohada Hospital in Behshahr city from July 2022 to March 2023. The women with GDM were divided into two groups for intervention and control through random block allocation. The intervention group received 8 virtual counseling sessions once a week for 45–50 min continuously based on stress management, while the control group only received antenatal usual care (AUC). The data were measured before and after the intervention using Fasting Blood Sugar [FBS] and HbA1c (glycated hemoglobin) tests, SDSCA [summary of diabetes self-care activities, NuPDQ‑17 [Prenatal Distress Questionnaire]and DASS [stress, depression and anxiety] questionnaires.
Results
The mean FBS in the intervention group were significantly lower than the control group after the intervention (
P
< 0.001, η2 = 0.49). The HbA1c level was lower in the intervention group than in the control group, but not statistically significant (
P
= 0.078). The mean score of SDSCA after counseling in the intervention group was significantly higher than the control group (
P
< 0.001, η2 = 0.79). Also, the NuPDQ-17 after counseling in the intervention group was significantly lower than the control group (
P
< 0.001, η2 = 0.67). Moreover, the mean scores of the depression (
P
< 0.001, η2 = 0.82), anxiety (
P
< 0.001, η2 = 0.67) and stress (
P
< 0.001, η2 = 0.77) were significantly lower in the intervention group than in the control group.
Conclusion
Stress management-based self-care counseling to prenatal usual care could be considered as an adjunctive care option for reducing on blood sugar and increasing the self-care activities of pregnant women with gestational diabetes and reducing their stress during pregnancy.
Journal Article
Integration of a fasting-mimicking diet programme in primary care for type 2 diabetes reduces the need for medication and improves glycaemic control: a 12-month randomised controlled trial
by
Lamb, Hildo J.
,
van den Burg, Elske L.
,
van den Akker-van Marle, Elske M.
in
Adolescent
,
Adult
,
Aged
2024
Aims/hypothesis
The aim of this study was to evaluate the impact on metabolic control of periodic use of a 5-day fasting-mimicking diet (FMD) programme as an adjunct to usual care in people with type 2 diabetes under regular primary care surveillance.
Methods
In this randomised, controlled, assessor-blinded trial, people with type 2 diabetes using metformin as the only glucose-lowering drug and/or diet for glycaemic control were randomised to receive 5-day cycles of an FMD monthly as an adjunct to regular care by their general practitioner or to receive regular care only. The primary outcomes were changes in glucose-lowering medication (as reflected by the medication effect score) and HbA
1c
levels after 12 months. Moreover, changes in use of glucose-lowering medication and/or HbA
1c
levels in individual participants were combined to yield a clinically relevant outcome measure (‘glycaemic management’), which was categorised as improved, stable or deteriorated after 1 year of follow-up. Several secondary outcome measures were also examined, including changes in body weight.
Results
One hundred individuals with type 2 diabetes, age 18–75 years, BMI ≥27 kg/m
2
, were randomised to the FMD group (
n
=51) or the control group (
n
=49). Eight FMD participants and ten control participants were lost to follow-up. Intention-to-treat analyses, using linear mixed models, revealed adjusted estimated treatment effects for the medication effect score (−0.3; 95% CI −0.4, −0.2;
p
<0.001), HbA
1c
(−3.2 mmol/mol; 95% CI −6.2, −0.2 and −0.3%; 95% CI −0.6, −0.0;
p
=0.04) and body weight (−3.6 kg; 95% CI −5.2, −2.1;
p
<0.001) at 12 months. Glycaemic management improved in 53% of participants using FMD vs 8% of control participants, remained stable in 23% vs 33%, and deteriorated in 23% vs 59% (
p
<0.001).
Conclusions/interpretation
Integration of a monthly FMD programme in regular primary care for people with type 2 diabetes who use metformin as the only glucose-lowering drug and/or diet for glycaemic control reduces the need for glucose-lowering medication, improves HbA
1c
despite the reduction in medication use, and appears to be safe in routine clinical practice.
Trial registration
ClinicalTrials.gov NCT03811587
Funding
The project was co-funded by Health~Holland, Top Sector Life Sciences & Health, the Dutch Diabetes Foundation and L-Nutra.
Graphical Abstract
Journal Article
The Impact of Optimal Glycemic Control on Tuberculosis Treatment Outcomes in Patients With Diabetes Mellitus: Systematic Review and Meta-Analysis
2024
Diabetes mellitus (DM) increases the risk of developing tuberculosis (TB), and optimal glycemic control has been shown to reduce the risk of complications and improve the TB treatment outcomes in patients with DM.
This study aims to investigate the role of glycemic control in improving TB treatment outcomes among patients with DM.
MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials databases were searched for randomized controlled trials (RCTs) assessing the impact of oral glycemic control in patients with TB who have DM. Outcomes of interest were radiological findings, treatment success, sputum positivity, and mortality. Evaluations were reported as risk ratios (RRs) with 95% CIs using weighted random-effects models.
The analysis included 6919 patients from 7 observational studies. Our meta-analysis showed significant differences between patients with optimal glycemic control and those with poor glycemic control with regard to improved treatment outcomes (RR 1.13, 95% CI 1.02-1.25; P=.02; I²=65%), reduced sputum positivity (RR 0.23, 95% CI 0.09-0.61; P=.003; I²=66%), and fewer cavitary lesions (RR 0.59, 95% CI 0.51-0.68; P<.001; I²=0%) in radiological findings. There was no significant difference between the 2 groups in terms of mortality (RR 0.57, 95% CI 0.22-1.49; P=.25; I²=0%), multilobar involvement (RR 0.57, 95% CI 0.22-1.49; P=.25; I²=0%) on radiologic examination, and upper lobe (RR 0.94, 95% CI 0.76-1.17; P=.58; I²=0%) and lower lobe (RR 1.05, 95% CI 0.48-2.30; P=.91; I²=75%) involvement on radiologic examination.
We concluded that optimal glycemic control is crucial for reducing susceptibility, minimizing complications, and improving treatment outcomes in patients with TB with DM. Emphasizing effective health management and health care strategies are essential in achieving this control. Integrating comprehensive care among patients with TB with DM will enhance patient outcomes and alleviate the burden of disease in this population.
PROSPERO CRD42023427362; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=427362.
Journal Article