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PubMed2004

Impact of kidney transplantation on glycemic control and cardiovascular risk factors in insulin-treated diabetic patients receiving cyclosporine: a longitudinal study.

BACKGROUND: In insulin-treated patients with diabetes, kidney transplantation (KTP) may influence glycemic control, insulin requirements, as well as vascular risk profiles, but the data are controversial. In 10 selected insulin-treated diabetic patients with normally functioning kidney transplants, receiving cyclosporine for immunosuppression, we evaluated the fasting blood glucose, HbA1c, lipid levels, blood pressure, and insulin-requirement from 1 year before to 1 year after KTP. RESULTS: There were no significant differences in the mean HbA1c levels 6 and 3 months before transplantation (8.3 +/- 1.7 and 8.0 +/- 1.4%, respectively) and 3 and 12 months after transplantation (8.2 +/- 1.6 and 7.9 +/- 1.5%, respectively). The mean fasting blood glucose levels increased only transiently by 7% during the first week after transplantation (not significant). The insulin requirement was approximately the same at 3 and 6 months before (42 +/- 14 and 42 +/- 13 IU/d, respectively) and at 3 and 12 months after transplantation (44 +/- 13 and 41 +/- 13 IU/mL, respectively). Only 1 week after transplantation did the insulin requirement increase transiently by 14% to 48 +/- 14 IU/d (P < .05). The mean levels of cholesterol and triglycerides as well as mean blood pressure were not significantly different before and after transplantation. CONCLUSION: Only immediately after KTP did mean blood glucose and insulin requirement increase. At least 3 months after transplantation, glycemic control and insulin requirements as well as the vascular risk factors were approximately the same as before the procedure.

Adult↗

PubMed1997

Role of IGF binding protein-1 in the dawn phenomenon and glycemic control in children and adolescents with IDDM.

OBJECTIVE: To clarify the involvement of IGF binding protein (IGFBP)-1 in the dawn rise in plasma glucose and in the overall glycemic control in patients with IDDM. RESEARCH DESIGN AND METHODS: Seventy patients with IDDM were divided into three groups according to pubertal development. Blood samples were obtained for measuring plasma glucose, IGFBP-1, and free insulin at 2200, 0500, and 0700 over a 2-day period. Levels of HbA1c, IGF-1, and IGFBP-3 were determined at 0700. Urinary growth hormone (GH) was collected overnight. To examine its frequency, the dawn phenomenon was defined on the basis of the following: 1) change in plasma glucose from 0500 to 0700, 2) plasma glucose level at 0700, and 3) no antecedent hypoglycemia. RESULTS: There was a statistically significant link between the dawn changes in plasma glucose and IGFBP-1 (r = 0.37, P < 0.01). The former was not related to the change in free insulin or to the overnight urinary GH level. In stepwise regression analyses, plasma glucose at 0700 = 0.03 IGFBP-1 (P < 0.01) + 0.525 HbA1c (P < 0.01) + 3.696 (R2 = 51%). Approximately half of the patients in each group exhibited the dawn phenomenon; 38% of patients with HbA1c < 8% also showed the dawn phenomenon. CONCLUSIONS: We have demonstrated a statistically significant link between the morning risk in IGFBP-1 and plasma glucose. The free fraction of IGF-1 modulated by acute changes in IGFBP-1 may play a direct role. The dawn phenomenon may occur regardless of pubertal stage or glycemic control in children and adolescents with IDDM.

Adolescent↗

PubMed2002

Effect of wheat bran on glycemic control and risk factors for cardiovascular disease in type 2 diabetes.

OBJECTIVE: Cohort studies indicate that cereal fiber reduces the risk of diabetes and coronary heart disease (CHD). Therefore, we assessed the effect of wheat bran on glycemic control and CHD risk factors in type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 23 subjects with type 2 diabetes (16 men and 7 postmenopausal women) completed two 3-month phases of a randomized crossover study. In the test phase, bread and breakfast cereals were provided as products high in cereal fiber (19 g/day additional cereal fiber). In the control phase, supplements were low in fiber (4 g/day additional cereal fiber). RESULTS: Between the test and control treatments, no differences were seen in body weight, fasting blood glucose, HbA(1c), serum lipids, apolipoproteins, blood pressure, serum uric acid, clotting factors, homocysteine, C-reactive protein, magnesium, calcium, iron, or ferritin. LDL oxidation in the test phase was higher than that seen in the control phase (12.1 +/- 5.4%, P < 0.034). Of the subjects originally recruited, more dropped out of the study for health and food preference reasons from the control phase (16 subjects) than the test phase (11 subjects). CONCLUSIONS: High-fiber cereal foods did not improve conventional markers of glycemic control or risk factors for CHD in type 2 diabetes over 3 months. Possibly longer studies are required to demonstrate the benefits of cereal fiber. Alternatively, cereal fiber in the diet may be a marker for another component of whole grains that imparts health advantages or a healthy lifestyle.

Blood Glucose↗

PubMed2003

Carbohydrate intake and biomarkers of glycemic control among US adults: the third National Health and Nutrition Examination Survey (NHANES III).

BACKGROUND: Recommendations for preventing and treating type 2 diabetes include consuming carbohydrates, predominantly from whole grains, fruit, vegetables, and low-fat milk. However, the quantity and type of carbohydrates consumed may contribute to disorders of glycemic control. OBJECTIVE: We evaluated the association between carbohydrate intakes and biomarkers of glycemic control in a nationally representative sample of healthy US adults who participated in a cross-sectional study, the third National Health and Nutrition Examination Survey. DESIGN: The sample (5730 men and 6125 women aged > or = 20 y) was divided into quintiles of carbohydrate intake (as a percentage of energy). Carbohydrate intakes were examined in relation to glycated hemoglobin (Hb A(1c)), plasma glucose, serum C-peptide, and serum insulin concentrations by using logistic regression. RESULTS: Carbohydrate intakes were not associated with Hb A(1c), plasma glucose, or serum insulin concentrations in men or women after adjustment for confounding variables. Carbohydrate intakes were inversely associated with serum C-peptide concentrations in men and women. Odds ratios for elevated serum C-peptide concentrations for increasing quintiles of carbohydrate intake were 1.00, 0.88, 0.57, 0.39, and 0.75 (P for trend = 0.016) in men, and 1.00, 0.69, 0.57, 0.36, and 0.41 (P for trend = 0.007) in women. When carbohydrate intakes were further adjusted for intakes of total and added sugar, the association of serum C-peptide with carbohydrate intakes was strengthened in men. CONCLUSIONS: Carbohydrate intakes were not associated with Hb A(1c), plasma glucose, or serum insulin concentrations but were inversely associated with the risk of elevated serum C-peptide; this supports current recommendations regarding carbohydrate intake in healthy adults.

Adult↗

PubMed2000

Repaglinide/troglitazone combination therapy: improved glycemic control in type 2 diabetes.

OBJECTIVE: This multicenter open-label clinical trial compared the efficacy and safety of repaglinide/troglitazone combination therapy, repaglinide monotherapy, and troglitazone monotherapy in type 2 diabetes that had been inadequately controlled by sulfonylureas, acarbose, or metformin alone. RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes (n = 256) who had inadequate glycemic control (HbA1c > or =7.0%) during previous monotherapy were randomly assigned to receive repaglinide (0.5-4.0 mg at meals), troglitazone (200-600 mg once daily), or a combination of repaglinide (1-4 mg at meals) and troglitazone (200-600 mg once daily). After a 4-6 week washout period, the trial assessed 22 weeks of treatment: 3 weeks (weeks 0-2) of forced titration, 11 weeks of fixed-dose treatment (weeks 3-13), and 8 weeks (weeks 14-21) of titration to maximum dose. Changes in HbA1c and fasting plasma glucose (FPG) values were measured. RESULTS: The combination therapy showed a significant reduction in mean HbA1c values (-1.7%) that was greater than with either type of monotherapy Repaglinide monotherapy resulted in a reduction of HbA1c values that was significantly greater than troglitazone (-0.8 vs. -0.4%) (P < 0.05). Combination therapy was more effective in reducing FPG values (-80 mg/dl) than either repaglinide (-43 mg/dl) or troglitazone (-46 mg/dl) monotherapies. Adverse events were similar in all groups. CONCLUSIONS: Combination therapy with repaglinide and troglitazone leads to better glycemic control than monotherapy with either agent alone. Repaglinide monotherapy was more effective in lowering HbA1c levels than troglitazone monotherapy Repaglinide/troglitazone combination therapy was effective and did not show unexpected adverse events.

Adult↗

PubMed2005

[The effects of problem solving nursing counseling and intensified walking exercise on diabetic self-care, coping strategies, and glycemic control among clients with DM Type II].

PURPOSE: The purpose of the study was to identify the effects of problem solving nursing counseling and intensified walking exercise on diabetic self-care, coping strategies, and glycemic control among older adults with DM type II. METHOD: Ninety nine DM patients who were older than 50 were recruited from DM clinics or public health centers and conveniently assigned into three groups: the Polar (n=41), counseling (n=30) and control groups (n=28). Participants in both Polar and counseling groups attended weekly problem solving nursing counseling for 12 weeks. Polar heart rate monitors were used in the Polar group to intensify walking exercise. Data was collected from November 2003 to August 2004 and analyzed by ANOVA or ANCOVA using the SPSS WIN program. RESULT: After a 12 week intervention, participants in both the Polar and counseling groups reported increased diabetic self care behaviors and decreased blood glucose levels, which is significantly different from those in the control group. There were no distinctively different program effects between the Polar and counseling groups. CONCLUSION: Based on the findings, we concluded that problem solving counseling alone could have positive effects on diabetic self care and glycemic controls for older adults with DM. Future research is needed to identify long-term effects of the program.

Adaptation, Psychological↗

PubMed1995

Glycemic control, growth and complications in children with insulin-dependent diabetes mellitus--a study of children enrolled in a Summer camp program for diabetics in Kinki district, Japan.

The influence of glycemic control on growth and on the development of complications in diabetic children was studied. The subjects of the study were 107 children with insulin-dependent diabetes mellitus (IDDM), who were enrolled in a Summer camp program for diabetic children in Kinki District, Japan from 1972 to 1990, and who had at least three determinations of HbA1 during the observation period. Many of the children had high mean levels of HbA1, regardless of age. The height and weight were below the standards for the respective ages in many children, indicating the retardation of growth. However, S.D. scores for height and weight and other physical indices were not related to the mean levels of HbA1. By contrast, the prevalence of diabetic retinopathy was related to an elevated mean level of HbA1, but that of albuminuria was not. Serum cholesterol levels were higher in children with higher mean levels of HbA1, but serum triglycerides appeared not to be related to glycemic control. The incidence of retinopathy during the observation period closely related to the degree of the mean levels of HbA1, but that of albuminuria did not.

Adolescent↗

PubMed1997

Effects of Trp64Arg mutation in the beta 3-adrenergic receptor gene on weight loss, body fat distribution, glycemic control, and insulin resistance in obese type 2 diabetic patients.

OBJECTIVE: To investigate the effects of Trp64Arg mutation in the beta 3-adrenergic receptor gene on weight loss, body fat distribution, glycemic control, and insulin resistance in obese type 2 diabetic patients. RESEARCH DESIGN AND METHODS: We measured body weight, waist-to-hip ratio (WHR), adjusted resting metabolic rate, fasting blood glucose, fasting serum insulin levels, insulin resistance index (fasting glucose x fasting insulin/22.5), and HbA1c levels before and after 12 weeks of obesity treatment in 61 obese women with type 2 diabetes. The MvaI polymorphism of the beta 3-adrenergic receptor gene was determined by polymerase chain reaction-restriction fragment length polymorphism analysis. RESULTS: Of obese type 2 diabetic patients, those with the mutation (n = 24) had a higher WHR (P < 0.001), a lower adjusted metabolic rate, and higher blood glucose levels, serum insulin levels, insulin resistance index (P < 0.001), and HbA1c levels (P = 0.016). Furthermore, patients with the mutation had smaller decreases in body weight, WHR, insulin resistance index, and HbA1c levels after the weight-loss program compared with patients without the mutation (n = 37), even though food intake, exercise, and serum thyroid hormone levels were similar in both groups. CONCLUSIONS: These present findings show that the Trp64Arg allele of the beta 3-adrenergic receptor gene may predict difficulty in losing body weight, lowering WHR, and improving glycemic control and insulin resistance in obese patients with type 2 diabetes.

Adult↗

PubMed1990

Glycemic control and neuropsychologic function during hypoglycemia in patients with insulin-dependent diabetes mellitus.

STUDY OBJECTIVE: To evaluate counterregulatory hormone secretion and neuropsychologic function during hypoglycemia in two groups of patients with insulin-dependent diabetes mellitus: those with good and those with poor glycemic control. DESIGN: Cross-sectional physiologic and neuropsychologic evaluation. SETTING: Clinical research unit of a referral-based diabetes clinic. PATIENTS: Eight patients with well controlled diabetes (glycosylated hemoglobin [HgbA1], 8.0% +/- 0.2%), nine patients with poorly controlled diabetes (HgbA1, 11.8% +/- 0.4%), and ten healthy persons. INTERVENTIONS: The insulin clamp technique was used to produce a stepwise decline in plasma glucose from 5.0 to 2.2 mmol/L over 3 hours. Tests of attention, memory, visual-spatial skills, visual-motor skills, and global cognition; a symptom survey; and counterregulatory hormone measurements were done at glucose decrements of 0.6 mmol/L. MEASUREMENTS AND MAIN RESULTS: Patients with well controlled diabetes did not differ statistically from those with poorly controlled diabetes regarding the median glucose threshold for dysfunction in visual-spatial skills, visual-motor skills, or global cognition. In contrast, glycemic thresholds for an increase in adrenergic symptoms and release of epinephrine, norepinephrine, cortisol, and growth hormone were lower in patients with well controlled diabetes than in those with poorly controlled diabetes (P less than 0.05 to 0.005). CONCLUSIONS: Despite alterations in the glucose levels at which adrenergic symptoms of hypoglycemia occur and counterregulation begins, there is no statistically detectable change in the glucose threshold at which cognitive deterioration occurs in diabetic persons with strict glycemic control. This dissociation of neuropsychologic function and counterregulatory hormone secretion suggests that diabetic patients with good glycemic control are at increased risk for developing cognitive impairment before the onset of adrenergic symptoms during hypoglycemia.

Adult↗

PubMed1994

Serum 1,5-anhydroglucitol (1,5 AG): new clinical marker for glycemic control.

We review the use of 1,5-anhydroglucitol (1,5 AG) in diagnosing and monitoring patients with diabetes. This six-carbon chain monosaccharide is one of the major polyols present in humans. Its concentration in serum is normally about 12 to 40 micrograms/ml. This substance is derived mainly from food, is well absorbed in the intestine, and is distributed to all organs and tissues. It is metabolically stable, being excreted in the urine when its level exceeds the renal threshold. It is reabsorbed in the renal tubules, and is competitively inhibited by glucosuria, which leads to a reduction in its level in serum. The correlation between this reduction and the amount of glucose present in urine is so close that 1,5 AG can be used as a sensitive, day-to-day, real-time marker of glycemic control. It provides useful information on current glycemic control and is superior to both HbA1c and fructosamine in detecting near-normoglycemia.

Biomarkers↗

PubMed1991

Effects of a very-low-calorie diet on long-term glycemic control in obese type 2 diabetic subjects.

We tested the hypothesis that the use of a very-low-calorie diet (VLCD) in combination with behavior modification would promote long-term glycemic control in obese type 2 diabetic subjects. Thirty-six diabetic subjects were randomly assigned to a standard behavior therapy program or to a behavior therapy program that included an 8-week period of VLCD. The behavior therapy group consumed a balanced diet of 4200 to 6300 J/d throughout the 20-week program. The VLCD group consumed a balanced diet of 4200 to 6300 J for weeks 1 to 4, followed by a VLCD (1680 J/d of lean meat, fish, and fowl) for weeks 5 to 12. The VLCD group then gradually reintroduced other foods during weeks 13 to 16 and consumed a balanced diet of 4200 to 6300 J/d for weeks 17 to 20. Thirty-three of the 36 subjects completed the 20-week program and the 1-year follow-up. Use of the VLCD produced greater decreases in fasting glucose at the end of the 20-week program and at 1-year follow-up and greater long-term reductions in HbA1. The VLCD group also had greater weight losses at week 20, but weight losses from pretreatment to 1-year follow-up were similar in the two treatment groups. The improved glycemic control with the VLCD appeared to be due to increased insulin secretion, but further research is needed to confirm this.

Adult↗

PubMed2006

Relationship between hemoglobin A1c and blood glucose throughout the day in well-glycemic-controlled medical nutrition therapy alone type 2 diabetic patients.

OBJECTIVE: To investigate the relationship between glycosylated hemoglobin A1c (HbA1c) and blood glucose levels of eight different points throughout the day in well-glycemic-controlled medical nutrition therapy (MNT) alone type 2 diabetic patients. METHODS: Data were collected as' capillary blood glucose value of eight different sample points among sixteen observing days in thirty MNT alone type 2 diabetic patients. The correlation between HbA1c and capillary blood glucose value was evaluated by Pearson's correlation method. RESULTS: The r-values between HbA1c and capillary blood glucose of 3:00, 6:00, and bedtime (22:00-23:00) were 0.81, 0.79, and 0.78, respectively (P < 0.001). The best correlation was found between the mean value of 8-point blood glucose value throughout the day and HbA1c (r = 0.84, P < 0.001). CONCLUSION: Fasting blood glucose and postabsorptive blood glucose have better correlations with HbA1c compared with other points in this group of well-glycemic-controlled MNT alone type 2 diabetic patients.

Adult↗

PubMed1999

Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients.

OBJECTIVE: Accurate and reliable HbA1c results can be obtained at the time of the office visit by using benchtop analyzers. We tested the hypothesis that immediately available HbA1c results could improve glycemic control by changing physician or patient behavior or both. RESEARCH DESIGN AND METHODS: A randomized controlled trial was conducted in 201 type 1 and insulin-treated type 2 diabetic patients attending an academic diabetes center. HbA1c levels, changes in insulin therapy, and use of health care resources were assessed during a 12-month follow-up period. RESULTS: HbA1c levels decreased significantly at 6 and 12 months in the immediate assay group (-0.57 +/- 1.44 and -0.40 +/- 1.65%, respectively; P < 0.01) but did not change in the control group (-0.11 +/- 0.79 and -0.19 +/- 1.16%, respectively; NS). The changes were similar for both type 1 and type 2 diabetic patients. There were no differences in the rates of hypoglycemic events or use of health care resources. CONCLUSIONS: In the setting of a controlled randomized trial, the immediate feedback of HbA1c results at the time of patient encounters resulted in a significant improvement of glycemic control at 6-month follow-up and persisted for the 12-month study. The introduction of this assay was positively received by both patients and physicians.

Blood Glucose↗

PubMed2004

Lessons learnt from influences of the Marmara earthquake on glycemic control and quality of life in people with type 1 diabetes.

To examine the short- and long-term influences of the Marmara earthquake, which occurred on August 17, 1999 in Turkey, on glycemic control and quality of life (QOL), HbA1c, insulin requirement and QOL of 88 people with type 1 diabetes living in the quake zone were evaluated one year before (PreE), 3 months after (PostE) and one year after (FE) the earthquake. HbA1c levels and daily insulin requirements increased significantly at PostE (HbA1c from 7.4 +/- 1.3% to 8.5 +/- 1.8%, p<0.05; insulin from 0.58 +/- 0.2 IU/kg/day to 0.77 +/- 0.2 IU/kg/day, p<0.05). Mean total QOL scores at PostE were significantly lower than the scores obtained at PreE (62.7 +/- 17.3 vs 74.2 +/- 13.4, p<0.001). There were no significant differences between HbA1c levels and total QOL scores at PreE and FE. People with type 1 diabetes living in the same house after the earthquake and not having enough food supply were reported to have lower QOL than people moving to another house and having enough food supply after the earthquake (p = 0.014, p<0.0001, respectively). The Marmara Earthquake had a negative impact on the glycemic control and QOL of the subjects with type 1 diabetes for the short term but prequake scores might be achieved after a long period.

Adolescent↗

PubMedDate not supplied

Lack of effect of improved glycemic control on C-peptide secretion in patients without residual B-cell function.

Ten patients with insulin-dependent diabetes mellitus underwent a program of intensification of therapy that resulted in marked improvement in glycemic control. C-peptide secretion in response to a test meal and to an intravenous glucagon challenge was used to assess pancreatic B-cell function in terms of residual endogenous insulin secretion. Patients, who had diabetes for a mean (+/- SEM) of 8.4 +/- 1.9 yr, had minimal or no C-peptide response at baseline evaluation. C-peptide responses remained unchanged when reassessed after 2, 4, and 6 mo of improved glycemic control.

Blood Glucose↗

PubMed2003

Association of younger age with poor glycemic control and obesity in urban african americans with type 2 diabetes.

BACKGROUND: Type 2 diabetes mellitus is highly prevalent in minority populations in the United States. We studied the relationship of age to glycemic control in a predominantly urban African American population with type 2 diabetes. METHODS: We selected all patients with type 2 diabetes who were enrolled in the Grady Diabetes Clinic, Atlanta, Ga, between April 1, 1991, and December 31, 1998, and had a hemoglobin A(1c) (HbA(1c)) level measured at their initial visit and at follow-up 5 to 12 months later (n = 2539). Patients were divided into 4 age categories: less than 30 years, 30 to 49 years, 50 to 69 years, and more than 69 years old. We also studied the relationship of age to HbA(1c) level in a primary care clinic. RESULTS: At baseline, average HbA(1c) levels were 9.9%, 9.5%, 9.2%, and 8.8% in the 4 groups ranked in increasing age, respectively (P<.001), and body mass indexes (calculated as weight in kilograms divided by the square of height in meters) were 37.8, 33.9, 31.6, and 29.2, respectively (P<.001). On follow-up, HbA( 1c) level improved in all groups (P<.001), but there was still a trend for younger patients to have higher levels of HbA(1c). There was little change in body mass index with time. Younger age, longer diabetes duration, higher body mass index, less frequent interval visits, and treatment with oral agents or insulin were associated with a higher HbA(1c) level at follow-up. Our findings in a primary care clinic showed also that HbA( 1c) level and body mass index were negatively correlated with age (P<.001). CONCLUSION: Our data show a high prevalence of obesity and poor glycemic control in young adult urban African Americans with diabetes.

Adult↗

PubMed2005

Paradoxical increase in ventricular torsion and systolic torsion rate in type I diabetic patients under tight glycemic control.

OBJECTIVES: This study sought to characterize the early features of diabetic cardiomyopathy by magnetic resonance imaging (MRI) tagging. BACKGROUND: The earliest manifestations of diabetic cardiomyopathy have not been well established, especially under tight glycemic management. We hypothesized that torsion measurements would identify subclinical contractile alterations in type I diabetics with normal left ventricular ejection fraction, mass, blood pressure, and aggressive glycemic control. We also sought to characterize the influence of elevated resting heart rates (HRs) of diabetics on torsion. METHODS: Sixteen patients with type I diabetes and 10 control patients underwent cine and tagged MRI with a 1.5-T scanner. Torsion, strain, and their rates were measured. To quantify the influence of chronotropic and inotropic stimulation on torsion, nine healthy volunteers underwent MRI tagging at rest, after atropine injection, and after exercise. RESULTS: Diabetic patients (hemoglobin A1c, 6.8 +/- 0.4%) had a higher resting HR (77.0 +/- 12.4 beats/min vs. 59.0 +/- 5.6 beats/min; p < 0.01), higher maximal torsion by 23% (3.5 +/- 0.9 degrees/cm vs. 2.7 +/- 0.4 degrees/cm; p < 0.01) and higher maximal systolic torsion rate (TR-s) by 25% (0.013 +/- 0.003 degrees/cm/s vs. 0.010 +/- 0.002 degrees/cm/s, p = 0.01). Torsion did not significantly change with chronotropic stimulation (p = 0.30). CONCLUSIONS: In diabetics under tight glycemic control, we observed a surprising increase in torsion and TR-s unrelated to chronotropic influences of HR. We propose that increased torsion and TR-s could represent early predictive markers of the propensity to cardiac dysfunction in asymptomatic type I diabetics. Furthermore, these findings seem fundamental to the diabetic state itself and unaccounted for by other comorbidities.

Adult↗

PubMed2026

Intensive glycemic control in adults aged 80 years and older: A randomized trial evaluating diabetes complications and competing mortality.

AIMS: To evaluate whether intensive glycemic control reduces microvascular or macrovascular events compared with conservative glycemic targets in independently ambulatory adults aged 80 years or older with type 2 diabetes. METHODS: We conducted a prospective, randomized, open-label, single-center trial enrolling independently ambulatory adults aged ≥ 80 years with type 2 diabetes. Participants were assigned (1:1) to an intensive glycemic target (HbA1c < 7 %) or a conservative target (HbA1c < 9 %) and followed for 5 years. Primary outcomes were composite microvascular and macrovascular events. Analyses were done by intention to treat. Cause-specific Cox models and Fine-Gray subdistribution hazard models were used to account for all-cause mortality as a competing event. This trial is registered with ClinicalTrials.gov, NCT00850798. FINDINGS: 206 participants were randomly assigned to intensive (n = 102) or conservative (n = 104) treatment. At 5 years, mean HbA1c was lower in the intensive group than in the conservative group (7·42 % vs 8·21 %; p = 0·005). Intensive therapy did not reduce microvascular events (hazard ratio [HR] 1·24, 95 % CI 0·76-2·04) or macrovascular events (HR 1·02, 0·36-2·92). Competing risk analyses showed no reduction in cumulative incidence of vascular outcomes (subdistribution HR approximately 1·0 for both). The cumulative incidence of death exceeded that of vascular events, indicating that many participants died before potential glycemic benefits could be realized. Severe hypoglycemia requiring hospitalization was more frequent with intensive therapy (7 vs 1 event). INTERPRETATION: In adults aged 80 years or older with type 2 diabetes, intensive glycaemic control improved glycaemic levels but did not reduce vascular events and increased the risk of severe hypoglycaemia. High competing mortality substantially limits the potential long-term benefit of intensive treatment, supporting conservative and individualized glycemic targets in very old adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00850798.

Aged, 80 and over↗