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Biomedical subjects

G Giani

Publications and source records attributed to G Giani.

At least 37 records · Page 2Linked to original sources

Hospitalization among diabetic children and adolescents and non-diabetic control subjects: a prospective population-based study.

AIM/HYPOTHESIS: Data comparing the hospitalization of diabetic paediatric patients with the non-diabetic population is scarce. We undertook a population-based incidence study to compare hospitalization in a cohort of Type I diabetic children and adolescents. in Germany, in the first course of treatment after diabetes onset, with hospitalization in non-diabetic control subjects matched for age, sex, and region. METHODS: A total of 373 subjects with newly diagnosed diabetes (onset between 1 and under 15 (<15) years of age in 1996 and 1997; 54% male, mean age at diagnosis 7.6 +/- 3.8 years) and 783 non-diabetic control subjects matched for age, sex, and region were followed for 1 year on average. Hospital admissions and the length of stay (days) were assessed by written questionnaires. Incidence rates of hospitalization and the expected number of hospital days per person-year were estimated for both cohorts. Using Poisson regression, we estimated ratios of hospitalization incidence rates (IRRs) and of expected numbers of hospital days (DRRs) in the diabetic cohort compared to the non-diabetic cohort, adjusting for age, sex and social status. RESULTS: Hospitalization incidence rates and hospital days, expressed per person-year (95%-CI). were 0.34 (0.29-0.39) and 2.36 (2.22-2.50) in the diabetic cohort and 0.07 (0.05-0.09) and 0.29 (0.26-0.33) in the non-diabetic cohort, respectively. Among diabetic subjects, both parameters were associated with higher age and female sex. IRR and DRR (95%-CI) were 4.7 (3.5-6.5) and 7.7 (6.7-8.9). CONCLUSION/INTERPRETATION: In the first year after onset, children and adolescents with diabetes had a 4.7 times higher hospitalization risk and spent 7.7 times more days in hospital than non-diabetic subjects. The ratios were smaller than those in Finland and Denmark in the 1980s, most likely due to differences between health care systems and time trends.

Adolescent↗

Incidence of blindness in southern Germany between 1990 and 1998.

AIMS/HYPOTHESIS: A reduction of diabetes-related blindness by at least one third was declared a primary objective for Europe in 1989 (St. Vincent Declaration). To ascertain a potential change of incidence rates, we collected data on blindness in a German district (population: about 5 million) over 9 years. METHODS: We obtained complete lists of newly registered blindness-allowance recipients between 1990 and 1998 and population data on Württemberg-Hohenzollern, Germany. We estimated incidence rates of blindness in the general population and the diabetic population. To ascertain any time trend, we applied Poisson regression models. RESULTS: There were 6371 newly registered blindness allowance recipients (1990-1998). Of these 67% were women and 27 % had diabetes. Mean age was 71.7 years. Standardised results in the diabetic population (incidence rates per 100,000 person-years; standard: diabetic population; 95 % CI): 1990: 72 (61;82); 1991: 88 (76;100); 1992: 77 (67;88); 1993: 82 (71;93); 1994: 62 (53;72); 1995: 82 (71;93); 1996: 70 (60;80); 1997: 69 (59;79); 1998: 59 (49;68). The Poisson model estimated a 3 % decrease of incident blindness in the diabetic population for each year (Relative risk per year 0.97; CI: 0.95; 0.99). No significant change could be observed in the non-diabetic population (Relative risk: 0.99; CI: 0.98; 1.00). Relative risks for each year varied between sub-groups according to sex, diabetic status and cause of blindness between 0.94 and 1.01. CONCLUSION/INTERPRETATION: A slight reduction of incident blindness could be shown but a reduction by one third has not been reached. Several possible sources of bias in the data have to be considered.

Adult↗

Pertussis in Germany: regional differences in management and vaccination status of hospitalized cases.

The incidence of pertussis requiring hospitalization in children younger than 16 years was estimated by the use of an active surveillance-system. Of special interest were differences between West and East Germany following different vaccination strategies before reunification. In 1997 and 1998, 754 pertussis cases required a total of 11,151 hospital inpatient days. The incidence of hospitalized pertussis was 2.68/100,000 person years and this was significantly higher in East than in West Germany. In East Germany an unusually high percentage of hospitalized cases was found in children aged 6-15 years (45% versus 13% in West Germany). The difference between the regions may be due either to a different perception of the disease or to an increased immunity induced by prior disease or vaccination. In East Germany, pertussis was rare until reunification but it has increased significantly since then. Older children may thus represent a population at risk of pertussis having not had previous exposure to pertussis antigens.

Adolescent↗

Low fecal elastase-1 in type I diabetes mellitus.

BACKGROUND: Previous studies suggested impaired pancreatic exocrine function in type I diabetes patients, but have been limited by small or highly selected samples. Fecal elastase-1 has facilitated evaluation of pancreatic dysfunction in population-based studies. METHODS: 112 type I diabetic patients (age +/- SD: 37 +/- 11 years; 47 % males; diabetes duration: 12.5 +/- 10.5 years) were consecutively selected from main regional diabetes centers in Essen, West-Germany. 116 non-diabetic control subjects, similar with respect to age and sex, were recruited from the same geographical region. Elastase-1 measurement was performed centrally by ELISA (ScheboTech, Germany). RESULTS: Elastase-1 concentrations in type I diabetic patients were significantly lower than in control subjects (median; inter-quartile range: diabetic patients: 227, 98-386 microgram/g stool; non-diabetic subjects: 544, 377-702 microgram/g stool) (p < 0.01). Elastase-1 < 100 microgram/g stool (E1 < 100) was found in 25.9 % of diabetic and 5.2 % of non-diabetic subjects, yielding an age-sex-adjusted prevalence Odds ratio (POR; 95 % CI) for diabetes and E1 < 100 of 6.9 (2.8-19.6). After adjusting for potential confounders (history of gastrointestinal diseases, smoking, alcohol consumption) the strong association remained (POR: 6.7; 2.7-19.2). Among patients with diabetes, E1 < 100 was associated with quality of glycemic control (HbA1c, change per 1 %: POR 1.5; 1.1-2.0), diabetes duration (per year: POR 1.1; 1.03-1.2), and age at diabetes onset (per age year: POR 1.1; 1.02-1.1). No association was found with history of gastrointestinal diseases, smoking, or alcohol consumption (current, life-time). CONCLUSIONS: Fecal elastase-1 concentrations were lower in type I diabetes patients compared to control subjects, indicating impaired pancreatic exocrine function. Low elastase-1 was associated with poor metabolic control and longer diabetes duration.

Adult↗

Low faecal elastase 1 concentrations in type 2 diabetes mellitus.

BACKGROUND: Previous studies have suggested an association between impaired pancreatic exocrine function and diabetes, but the evidence is weak because the invasive nature of the tests used to define exocrine function has led to small studies on selected patients. The availability of faecal elastase 1 as a non-invasive test has aided the detection of impaired exocrine function in population studies. We describe the association between levels of faecal elastase 1 and Type 2 diabetes. METHODS: 544 Type 2 diabetic patients (age: 63 +/- 8 years) were randomly selected from local diabetes registers in Cambridgeshire, UK and individually matched for age, sex and practice to 544 controls in whom diabetes was excluded by HbA1c measurement. RESULTS: Faecal elastase 1 concentrations were significantly lower in cases than controls (median: cases 308 microg/g; controls 418 microg/g; P < 0.01). Low levels of faecal elastase 1 (< 100 microg/g) were found in 11.9% of cases and 3.7% of controls (age-sex-adjusted odds ratio; 95% CI: 3.6; 2.2-6.2). After adjustment for potential confounding factors, the OR was 4.5 (2.6-8.3). Among patients with diabetes, poor glycaemic control (HbA1c > or = 7%) was associated with a higher risk of low elastase 1 level (OR 5.6; 1.5-37). No significant association was found with diabetes duration, peripheral neuropathy, alcohol intake, or prior gastrointestinal diseases. CONCLUSIONS: Faecal elastase 1 concentrations are lower in Type 2 diabetic patients than in non-diabetic controls, suggesting the co-existence of diabetes and impaired pancreatic exocrine function. Among the diabetic patients, the risk of having low elastase 1 levels was associated with glycaemic control.

Aged↗

Hospitalization among diabetic children and adolescents and the general population in Germany. German Working Group for Pediatric Diabetology.

OBJECTIVE: To compare hospitalization in a multicenter-based cohort of diabetic children and adolescents (aged 1-19 years) in Germany with that of the general population. RESEARCH DESIGN AND METHODS: Based on standardized documentation, hospital stays after manifestation were ascertained in diabetic subjects 1-19 years of age in 1997. Hospitalization data in the general German population were derived from official statistics. Incidence rates and numbers of hospital days were estimated. Ratios of hospitalization incidences and numbers of hospital days between the diabetic and the general population were calculated. Costs for hospital care in the German diabetic population in 1997 were determined. RESULTS: A total of 5,874 patients came from 61 pediatric centers (52% male, age [mean +/- SD] 12.2 +/- 4.3 years, diabetes duration 4.6 +/- 4.4 years). Hospitalization incidence rates and hospital days per person-year (95% CI) were 0.27 (0.25-0.29) and 1.80 (1.75-1.84) in the diabetic population and 0.0948 (0.0946-0.0949) and 0.6416 (0.6412-0.6420) in the general population. The standardized ratio of hospital incidences was 3.1 (2.9-3.2), and the ratio of numbers of hospital days was 2.8 (2.7-2.9). Costs for hospital care after manifestation were estimated to be $506 (U.S. dollars) per person-year and $12.4 million in the whole German diabetic population aged 1-19 years in 1997; including hospital stays at diabetes onset, total annual costs were $24 million ($970 per person-year). CONCLUSIONS: Diabetic children and adolescents in Germany had an approximately three times higher hospitalization risk and three times more hospital days than the age-matched general population. Including hospitalization at diabetes onset, the annual costs of hospital care for the German diabetic population aged 1-19 years amounted to approximately 1% of all costs for hospital care in this age-group. Thus, costs were largely overproportional (diabetes prevalence 0.1%).

Adolescent↗

Unchanged incidence of lower-limb amputations in a German City, 1990-1998.

OBJECTIVE: A reduction of diabetes-related amputations by at least one-half within 5 years was declared a primary objective for Europe (St. Vincent Declaration, 1989). We collected data about incidence rates of amputations in one German city (Leverkusen, with a population of approximately 160,000 inhabitants) between 1990 and 1998 to ascertain a potential change in rates of incidence. RESEARCH DESIGN AND METHODS: From all three hospitals in Leverkusen, we obtained complete lists of lower-limb amputations. From each patient record, diabetic status was determined. Only the first observed amputation was counted for the analysis. We estimated incidence rates of amputations in the entire population, the diabetic population, and the nondiabetic population. To test for time trend, we fitted Poisson regression models, adjusting for age and sex. RESULTS: During, the defined period (the years 1990, 1991, and 1994-1998), 339 patients (all residents of Leverkusen) without previous amputations had nontraumatic lower-limb amputations. Of all subjects. 46% were female. Moreover, 76% of the subjects were known to have diabetes. Mean age was 71.3 years. Incidence rates in the diabetic population (standardized to the estimated German diabetic population, per 100,000 person-years) were as follows: 1990, 549; 1991, 356; 1994, 544; 1995, 386; 1996, 426; 1997, 433; and 1998, 463. The Poisson models showed no significant change of incident amputations over time in the diabetic population or in the nondiabetic population. CONCLUSIONS: Beyond random variation, no change of incidence rates could be observed over the past 9 years. More specific interventions are needed to achieve a substantial reduction of diabetes-related amputations.

Adolescent↗

[Prescribing behavior of primary care physicians in diabetes therapy: effect of drug budgeting].

BACKGROUND AND OBJECTIVE: In spite of the great importance of diabetes in Germany, little is known about the medical treatment of diabetic patients by primary health care practices and the effects of the drug budget, introduced by the German Health Care Structure Reform Act (GSG) from 1993. PATIENTS AND METHODS: Computerized data (MediPlus, IMS HEALTH) on prescriptions of the most important drugs were analysed in 2892 diabetic patients of 362 primary care physicians for the period of July 1992 to December 1994. RESULTS: There was an initial decrease in prescriptions per treated patient of antidiabetic drugs and antihypertensive drugs according to the GSG, which was not maintained during the study period. Nevertheless, a cost saving per treated patient with respect to beta-blocker and ACE inhibitors was observed, mainly as a result of a change of preparations and a drop in drug company sales prices. When beginning of a new therapy with oral antidiabetics, the physicians increasingly used acarbose rather than less expensive sulphonylureas. A previous trend of increased use of ACE inhibitors and diuretics for antihypertensive treatment was maintained. In 1993 and 1994, the number of prescriptions and the prescription costs for lipid lowering drugs decreased compared to the values of the last six months of 1992. A global decrease in prescription use of drugs without proven efficacy observed in the first six months of 1993, did not persist. CONCLUSION: The data show, that the drug budget had no relevant long term impact on drug prescribing by internists and general practitioners for diabetic patients.

Adolescent↗

[Drug prescriptions and costs in diabetic polyneuropathy].

BACKGROUND AND OBJECTIVE: Numerous medications are used in the treatment of diabetic polyneuropathy (PNP) without evidence of their efficacy. This study was undertaken to obtain the costs of drugs prescribed to patients with PNP throughout the Federal Republic of Germany in primary-care practices. PATIENTS AND METHODS: Data (stored in the Medi-Plus data bank of the Institute for Medical Statistics, Frankfurt) from 400 primary-care practices were analysed for the year 1996 with regard to diagnoses and prescriptions for 40,112 diabetics over the age of > or = 20 years. A polyneuropathy (PNP) had been diagnosed in 3548 patients (8.8%) (age: 68 +/- 12 years, 56% women). The cost of medications listed for the treatment of PNP was identified and extrapolated to the total prescription cost for treated diabetic PNP in the whole of Germany. In addition the proportion of costs for drugs with unproven efficacy was calculated. RESULTS: Antidepressives were prescribed for 13%, carbamazepine for 4%, and lipoic (thioctic) acid for 41% of diabetics with PNP. Annual costs per patient (mean value) were DM 203 for lipoic acid, DM 53 for vasoactive drugs and DM 42 for analgesics. Projection for the estimated total number of diabetic patients with PNP treated in primary care practices (n = 361,400) gave a total cost of DM 116 million (95% confidence limit: DM 109-123), of which DM 41 million (35%) was for medications of unproven efficacy. CONCLUSION: In Germany one third of drug costs for diabetic patients with PNP in primary care is for medications of unproven efficacy. Cost-effective guidelines for the treatment of diabetic PNP are urgently required.

Aged↗

Temporal, seasonal, and geographical incidence patterns of type I diabetes mellitus in children under 5 years of age in Germany.

AIMS/HYPOTHESIS: To estimate the national incidence of Type I (insulin-dependent) diabetes mellitus in children under 5 years of age in Germany and to analyse temporal, seasonal, and geographical patterns of the diabetes incidence. METHODS: During 1993-1995 newly diagnosed subjects were prospectively registered by the hospital-based 'German Paediatric Surveillance Unit' with monthly inquiries in all paediatric departments in Germany. Level of ascertainment was estimated by capture-recapture-analysis using two independent regional data sources. RESULTS: During 1993-1995 the national incidence was 8.10 (95 %-CI: 7.61, 8.61) per 100 000 person-years, ranging in-between lower rates in west European countries and higher rates in northern Europe. Degree of ascertainment was about 85 %. Male to female ratio was 1.11 (95 %-CI: 0.98, 1.25). Compared with results of previous regional studies in the east and the south-west of Germany a 3- and 1.3-fold incidence increase was observed, respectively. Multivariate Poisson regression analysis showed season, geographical region, and interactions of age at onset with sex and calendar year to be independent significant predictors of the incidence. Incidence variation by age was different between boys and girls. A significant incidence increase by calendar year was found in 3- and 4-year-old children only. In summer and fall the incidence was higher than in winter and springtime, in the northern parts of the country higher than in the southern parts. CONCLUSION/INTERPRETATION: This study reports first national incidence data of Type I diabetes in children under the age of 5 years in Germany. Observed marked temporal, seasonal, and geographical incidence variations strongly support the causal role of environmental factors in disease aetiology.

Age Factors↗

Cardiovascular drug prescriptions and risk of depression in diabetic patients.

Our aim was to investigate the association of calcium channel blocker (CCB), beta-blocker, and ACE inhibitor medications with the risk of depression in diabetic patients. A case-control study was performed using an automated database (MediPlus, IMS) of 400 primary care practices in Germany including 972 diabetic cases with newly diagnosed depression in 1996 (index date) and 972 diabetic controls, matched for age, sex, and index date. The odds ratios (95%-confidence intervals) for depression, adjusted for type of practice, number of visits and prescriptions, hospitalization, cardiovascular diagnoses, and renal failure, were 2.2 (95% CI: 1.2-4.2) for exposure to CCB 6 months prior to index date, 2.6 (95% CI: 1.1-7.0) for beta-blockers, and 1.3 (95% CI: 0.8-2.2) for ACE inhibitors, respectively. Adjusted odds ratio for CCB (4.3; 95% CI: 1.7-13.5) and beta-blockers (4.5; 95% CI: 1.2-29.5) were higher with daily dosages above the median. Prescriptions of CCB and beta-blockers among diabetic patients may increase the risk of depression. Because this association may alternatively be explained by cardiovascular comorbidity, further studies will be necessary to investigate the link between these cardiovascular medications and depression.

Adrenergic beta-Antagonists↗

[Drug prescribing in primary health care for diabetic and non-diabetic patients: effect of therapeutic drug budgeting].

With computerised data on drug prescriptions, which were collected among a sample of 362 internist, general and medical practitioners throughout Germany, the effects of the drug budget, based on the German Health Care Structure Reform Act (GSG), on diabetic patients were analysed. The data of 3053 diabetic patients (10% random sample) were compared with the same number of nondiabetic patients for the period of July 1992 to December 1994. The frequency of consultations per patient increased in both groups during the study period (p < 0.01). Diabetic patients had more contacts with the physicians than nondiabetic subjects (p < 0.01). The prescriptions and costs among the patients with diabetes decreased in the first six month of 1993 (-10%/ -16%). In the following time costs increased and exceeded the values of 1992 by about 13%. The costs per prescription decreased during the study period about 10%. The data show that costs as well as prescriptions per consultation between diabetic and nondiabetic patients remained in the same ratio. The proportion of consultations with > or = 1 prescription increased in diabetic patients after the GSG. A refusal to prescribe drugs in primary health care practices among diabetic patients was not observed. There was also no restriction on prescription drug use among diabetic patients compared with nondiabetics.

Adult↗

Postmarketing surveillance of adverse drug reactions: a correlational study approach using multiple data sources.

The authors performed a correlational study on nationwide spontaneous adverse drug reaction (ADR) reports related to the antioxidant thioctic acid (Thioctacid; ASTA Medica) in Germany from April 1992 to March 1995. Thioctacid was predominantly utilized by general practitioners and internists for treatment of diabetic neuropathy. The total number of treated patients was estimated using a nationwide drug prescription database (MediPlus, IMS: 362 general practitioners and internists) and pharmacy drug sales data. All Thioctacid prescriptions in MediPlus were assessed and the mean cumulative dosage/patient/year was calculated. Then, the total number of Thioctacid patients in Germany was estimated: N=nationwide pharmacy sales (kg)/mean cumulative dosage/patient (kg). From April 1992 to March 1995, 78 patients with 112 ADRs were notified on spontaneous reports. There was a decreasing number of ADR reports per year (32 to 21 patients/year). In parallel, the estimated total numbers of treated patients/year also decreased from 426,658 to 304,155 (p<0.05). Poisson regression models were fitted including incident cases with ADR and the number of patients per year for each of the 3 years. No significant secular trend of ADR (p=0.91) and no impact of mean cumulative dosages was observed in the models. There were also no changes in the pattern of ADR (e.g. skin reactions, gastrointestinal complaints). This study suggests that a combination of spontaneous reporting systems with prescription drug databases and pharmacy sales data may be a useful tool to perform rapid postmarketing monitoring of ADR.

Journal Article↗

The Deutsche Nicotinamide Intervention Study: an attempt to prevent type 1 diabetes. DENIS Group.

On the basis of the positive outcome of animal experiments, several large placebo-controlled trials are underway and aiming for the first time at the prevention of an immune-mediated disease, type 1 diabetes. The first of these trials, The Deutsche Nicotinamide Intervention Study (DENIS), evaluated the clinical efficacy of high doses of nicotinamide in children at high risk for IDDM. Nicotinamide has been shown to protect beta-cells from inflammatory insults and to improve residual beta-cell function in patients after onset of IDDM. Individuals at high risk for developing IDDM within 3 years were identified by screening the siblings (age 3-12 years) of patients with IDDM for the presence of high titer (> or =20 Juvenile Diabetes Foundation [JDF] U) islet cell antibodies. Probands (n = 55) were randomized into placebo and nicotinamide (slow release, 1.2 g x m(-2) x day(-1)) receiving groups and followed prospectively in a controlled clinical trial using a sequential design. Rates of diabetes onset were similar in both groups throughout the observation period (maximum 3.8 years, median 2.1 years). This sequential design provides a 10% probability of a type II error against a reduction of the cumulative diabetes incidence at 3 years from 30 to 6% by nicotinamide. The trial was terminated when the second sequential interim analysis after the eleventh case of diabetes showed that the trial had failed to detect a reduction of the cumulative diabetes incidence at 3 years from 30 to 6% (P = 0.97). The group receiving nicotinamide exhibited decreased first-phase insulin secretion in response to intravenous glucose (P = 0.03). No other side effects were observed. We conclude that in this subgroup of diabetes-prone individuals at very high risk and with an assumed rapid disease progression, nicotinamide treatment did not cause a major decrease or delay of diabetes development. However, the data do not exclude the possibility of a less strong, but potentially meaningful, risk reduction in this cohort, or a major clinical effect of nicotinamide in individuals with less risk of progression to IDDM than studied here.

Austria↗

Prescription drug use and costs among diabetic patients in primary health care practices in Germany.

OBJECTIVE: To evaluate drug prescriptions and costs among diabetic patients in primary care practices in Germany. RESEARCH DESIGN AND METHODS: Computerized data on prescriptions and costs (drug company sales prices) were analyzed in 30,604 diabetic and 17,723 (5% random sample) nondiabetic patients from 362 primary care practices during 1994. Relative use ratios for drug groups were obtained from logistic regression models (odds ratio [OR] for diabetes) controlling for age, sex, and other covariates. Relative costs (diabetic:nondiabetic) were estimated by direct age and sex standardization. RESULTS: Diabetic patients had an increased prescription use for most drugs. A substantial increased use (OR > or = 1.4) was found for cardiovascular drugs, fibrates, gout medication, laxatives, and wound care products. Diabetic subjects (7.9% of all patients) accounted for 21% of total annual prescription costs in the practices. Total costs (U.S. dollars) per patient-year were threefold higher (diabetic patients $384; control subjects $123). After excluding antidiabetic agents and age- and sex-standardization, relative costs were still 1.5 times higher (P < 0.05). Diabetes treatment accounted for 24% of total costs in diabetic patients (insulin 12%; oral antidiabetics 6%). The most important cost factor was cardiovascular drugs (CVDs) (39%). Three CVD groups accounted for about 50% of total CVD costs in diabetic patients (ACE inhibitors 25%; Ca-antagonists 16%; nitrates 10%). CONCLUSIONS: Prescription use among diabetic patients in primary health care practices was predominantly increased for cardiovascular drugs and for treatment of diabetes-associated disorders. Diabetic patients accounted for over one-fifth of the total pharmacy costs in primary practices, indicating that diabetes is a major economic factor in drug use.

Aged↗

Blindness due to diabetes: population-based age- and sex-specific incidence rates.

Reducing the incidence of diabetic retinopathy and blindness was declared one of the main objectives in St Vincent. To date, hardly any valid data are available on the age- and sex-specific incidence of diabetes-related blindness. They are necessary, however, to evaluate intervention activities. Therefore, we used a population-based registry of blindness to calculate incidence of blindness due to diabetes. In one German district (Rhineland) we obtained complete lists of cases of blindness newly registered in 1990 and 1991 and coded as blind due to diabetes (n = 589). We estimated age-specific incidence rates in the entire as well as in the diabetic population. Incidence rates of blindness due to diabetes (100,000(-1) * year(-1)), standardized to the West-German population, were 3.2 (CI 95%: 2.9;3.4) in the entire population and 60.5 (CI 95%: 45.7;75.4) in the diabetic population. Incidence rates in the diabetic population showed a peak between 20 and 40 years of age, probably due to complications of Type 1 diabetes. Incidence was higher in diabetic women than in diabetic men (p < 0.05 at ages > or =40 years). Repeating the study will detect a decrease in the incidence of blindness due to diabetes by one-third with over 99% power.

Adolescent↗