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Managing Impending Nonsevere Hypoglycemia With Oral Carbohydrates in Type 1 Diabetes: The REVERSIBLE Trial
Abstract
OBJECTIVE
Current guidelines recommend initiating treatment for nonsevere (NS) hypoglycemia with 15 g carbohydrates (CHO) at 15-min intervals when blood glucose (BG) reaches <70 mg/dL (3.9 mmol/L). Despite this recommendation, NS hypoglycemia management remains challenging for individuals living with type 1 diabetes (T1D). We aimed to assess the efficacy of 15 g CHO at higher BG levels.
RESEARCH DESIGN AND METHODS
A total of 29 individuals with T1D participated in an open-label crossover study. After an inpatient subcutaneous insulin-induced decrease in BG in the fasting state, 16 g CHO was administered orally at a plasma glucose (PG) of <70 (3.9), ≤80 (4.5), or ≤90 mg/dL (5.0 mmol/L). The primary outcome was time spent in hypoglycemia (<70 mg/dL) after initial CHO intake.
RESULTS
When comparing the <70 (control) with the ≤80 and ≤90 mg/dL treatment groups, 100 vs. 86 (P = 0.1201) vs. 34% (P < 0.0001) of participants reached hypoglycemia, respectively. These hypoglycemic events lasted 26.0 ± 12.6 vs. 17.9 ± 14.7 (P = 0.026) vs. 7.1 ± 11.8 min (P = 0.002), with a PG nadir of 56.57 ± 9.91 vs. 63.60 ± 7.93 (P = 0.008) vs. 73.51 ± 9.37 mg/dL (P = 0.002), respectively. In the control group, 69% of participants required more than one treatment to reach or maintain normoglycemia (≥70 mg/dL), compared with 52% in the ≤80 mg/dL group and 31% in the ≤90 mg/dL group, with no significant rebound hyperglycemia (>180 mg/dL) within the first hour.
CONCLUSIONS
For some impending NS hypoglycemia episodes, individuals with TID could benefit from CHO intake at a higher BG level.
Aims
Non-severe hypoglycemia (NS-H) is challenging for people living with type 1 diabetes (PWT1D) and often results from relative iatrogenic hyper-insulinemia. Current guidelines recommend a one-size-fits-all approach of 15–20 g of simple carbohydrates (CHO) every 15 min regardless of the triggering conditions of the NS-H event. We aimed to test different amounts of CHO to treat insulin-induced NS-H at various glucose ranges.
Methods
This is a randomized, four-way, crossover study involving PWT1D, testing NS-H treatment outcomes with 16 g vs. 32 g CHO at two plasma glucose (PG) ranges: A: 3.0–3.5 mmol/L and B: <3.0 mmol/L. Across all study arms, participants consumed an additional 16 g of CHO if PG was still <3.0 mmol/L at 15 min and <4.0 mmol/L at 45 min post-initial treatment. Subcutaneous insulin was used in a fasting state to induce NS-H. Participants had frequent venous sampling of PG, insulin, and glucagon levels.
Results
Participants ( n = 32; 56% female participants) had a mean (SD) age of 46.1 (17.1) years, had HbA1c at 54.0 (6.8 mmol/mol) [7.1% (0.9%)], and had a diabetes duration of 27.5 (17.0) years; 56% were insulin pump users. We compared NS-H correction parameters between 16 g and 32 g of CHO for range A, 3.0–3.5 mmol/L ( n = 32), and range B, <3.0 mmol/L ( n = 29). Change in PG at 15 min for A: 0.1 (0.8) mmol/L vs. 0.6 (0.9) mmol/L, p = 0.02; and for B: 0.8 (0.9) mmol/L vs. 0.8 (1.0) mmol/L, p = 1.0. Percentage of participants with corrected episodes at 15 min: (A) 19% vs. 47%, p = 0.09; (B) 21% vs. 24%, p = 1.0. A second treatment was necessary in (A) 50% vs. 15% of participants, p = 0.001; (B) 45% vs. 34% of participants, p = 0.37. No statistically significant differences in insulin and glucagon parameters were observed.
Conclusions
NS-H, in the context of hyper-insulinemia, is difficult to treat in PWT1D. Initial consumption of 32 g of CHO revealed some advantages at the 3.0–3.5 mmol/L range. This was not reproduced at lower PG ranges since participants needed additional CHO regardless of the amount of initial consumption.
Clinical trial registration
ClinicalTrials.gov , identifier NCT03489967.
Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with diabetes. Within ongoing innovations in CGM technology, individuals now have an expanding array of options that allow them to select the device that meets their individual needs and preferences. Although demand for CGM in primary care continues to grow, many clinicians are reluctant to prescribe this technology due to their unfamiliarity with the various devices, uncertainty about which devices are best suited to each patient and the feasibility of using CGM. This article reviews the features and functionality of the most recent commercially available CGM devices and provides guidance for integrating CGM use into clinical practices.
Continuous glucose monitoring (CGM) is a powerful tool to support the optimization of glucose control of patients with diabetes. However, CGM systems measure glucose in interstitial fluid but not in blood. Rapid changes in one compartment are not accompanied by similar changes in the other, but follow with some delay. Such time delays hamper detection of, for example, hypoglycemic events. Our aim is to discuss the causes and extent of time delays and approaches to compensate for these.
CGM data were obtained in a clinical study with 37 patients with a prototype glucose sensor. The study was divided into 5 phases over 2 years. In all, 8 patients participated in 2 phases separated by 8 months. A total number of 108 CGM data sets including raw signals were used for data analysis and were processed by statistical methods to obtain estimates of the time delay.
Overall mean (SD) time delay of the raw signals with respect to blood glucose was 9.5 (3.7) min, median was 9 min (interquartile range 4 min). Analysis of time delays observed in the same patients separated by 8 months suggests a patient dependent delay. No significant correlation was observed between delay and anamnestic or anthropometric data. The use of a prediction algorithm reduced the delay by 4 minutes on average.
Prediction algorithms should be used to provide real-time CGM readings more consistent with simultaneous measurements by SMBG. Patient specificity may play an important role in improving prediction quality.
© 2015 Diabetes Technology Society.
Diabet. Med. 30, 209–215 (2013)
Aims Despite improvements in insulin therapy, hypoglycaemia remains an inevitable part of life for many people with Type 1 diabetes. Little attention has been paid to how individuals self-treat hypoglycaemia and their likes and dislikes of clinically recommended treatments. We explored participants’ experiences of self-treating hypoglycaemia after attending a structured education programme for people with Type 1 diabetes. Our aims were: to identify treatments that are acceptable to people with Type 1 diabetes; and to provide recommendations for promoting self-treatment in line with clinical guidelines.
Methods Thirty adults with Type 1 diabetes were recruited from the Dose Adjustment for Normal Eating (DAFNE) programme in the UK. Study participants were interviewed post-course and 6 and 12 months later, enabling their experiences to be explored over time.
Results Study participants described a poor knowledge of how to self-treat hypoglycaemia correctly pre-course. Post-course, individuals often struggled to adhere to clinically recommended guidelines because of: panic, disorientation, hunger sensations and consequent difficulties ingesting fixed quantities of fast-acting carbohydrate; use of sweets to manage hypoglycaemia; reversion to habituated practices when cognitive impairment as a result of hypoglycaemia supervened; difficulties ingesting dextrose tablets; and other people’s anxieties about under-treatment.
Conclusions Historical experiences of hypoglycaemia and habituated practices can influence present self-treatment approaches. Professionals need to be aware of the range of difficulties individuals may experience restricting themselves to fixed quantities of fast-acting carbohydrate to manage hypoglycaemia. There may be merit in developing a more acceptable range of treatments tailored to people’s own preferences, circumstances and needs.
Aims:
To evaluate the frequency and consequences of level 2 (L2H, glucose level <3.0 mmol/L with autonomous management) and level 3 hypoglycemia (L3H requiring external assistance to treat), in adults living with type 1 diabetes (T1D), while investigating the role of gender.
Methods:
Cross-sectional analysis of self-reported retrospective data from a Canadian registry of 900 adults living with T1D using logistic regression models adjusted for age, T1D management modalities, hypoglycemia history, and validated patient-reported outcomes scales. Changes in diabetes management, seeking healthcare resources, and impacts on daily well-being were explored.
Results:
Of the 900 adults (66% women, mean age 43.7 ± 14.8 years, mean T1D duration 25.5 ± 14.6 years), 87% used wearable diabetes technology. L3H in the past year was reported by 15% participants, similar between genders. Women reported more L2Hstudy analysis than men (median (Q1, Q3): 4 (2, 10) vs 3 (1,8), p=0.015), and were more likely to report persistent fatigue after both L2H and L3H (Odds ratio [95% confidence interval]: 1.95 [1.16, 3.28] and 1.86 [1.25, 2.75], respectively) and anxiety (1.70 [1.05, 2.75]) after a L3H.
Conclusions:
The findings suggest taking a gender-based differential approach when addressing hypoglycemia and its various consequences for people living with T1D.
Aim:
Self-management guidelines for non-severe hypoglycemia (NS-H) in type 1 diabetes recommend 15g simple carbohydrates (CHO) at 15-minute intervals. Since automated insulin delivery (AID) preventively reduce or suspend insulin infusion for imminent hypoglycemia, we aimed to assess if guidelines were excessive during AID.
Methods:
Secondary analysis of NS-H episodes during inpatient single-hormone (insulin) or dual-hormone (insulin and glucagon) AID trials with standardized CHO treatment protocols.
Results:
Forty NS-H episodes: 15 during single-hormone arms (2 trials) and 25 during dual-hormone arms (5 trials). At NS-H treatment T0min, plasma glucose (PG) levels were 3.1±0.6 mmol/l corresponding to sensor values of 3.6±0.6 mmol/L. Fifteen minutes post CHO consumption, PG increased by 0.9±0.8 mmol/l, recovering 45% of episodes to safe PG≥4.0 mmol/L. With repeated CHO consumption, time-to-recovery was 21.4±15.7 minutes without rebound hyperglycemia; PG one-hour post initial CHO: 5.9± 2.0 mmol/L. Outcome differences between single-hormone vs. dual-hormone systems were not statistically significant, except for higher insulin and glucagon levels and less repeated treatment in dual-hormone AID. PG and glucagon levels at T0min were positively associated with increase in PG at T15min and negatively associated with time-to-recovery.
Conclusion:
NS-H self-management CHO 15g/15min guidelines were neither excessive nor optimal during AID. There is a need to examine data with different AID systems to optimise treatment recommendations.
The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
Aims:
Compare the self-reported prevalence of severe hypoglycemia (level-3-H) in people with type 1 diabetes (PWT1D) according to two wording of definition: by the International Hypoglycemia Study Group (IHSG) and an alternate simplified version developed by patient-partners (PP).
Methods:
Cross-sectional study (PWT1D > = 14 years) self-reporting risk factors, patient-year incidence and annual prevalence of level-3-H were defined according to either IHSG's wording (low sugar levels requiring help from another person, or use of glucagon, or hospitalization, or loss of consciousness) or with an alternative simpler wording developed by PP (low sugar levels that you would have been unable to treat).
Results:
Among 1430 eligible participants, in the last 12 months, the annual prevalence of level-3-H (IHSG: 242/100 vs. PP: 231/100 patient-years, p = 0.229) and median number of episodes (IHSG: 2.0 [1-3] vs. PP: 1.0 [1-3], p = 0.359) were similar. The prevalence of participants reporting hypoglycemia in the past year was higher with IHSG wording (13.5% vs. 10.5%; p < 0.001); this difference was significantly (p < 0.001) larger among patients with impaired awareness of hypoglycemia. Association of both definitions with level-3-H risk factors was comparable.
Conclusions:
The level-3-H episodes by PP and IHSG wording were comparable. The simplicity of PP wording may allow better mutual understanding between patients and healthcare team.
Trial registration:
NCT03720197 (registered on October 19th 2018).
Objective
The BETTER registry is a type 1 diabetes population surveillance system co-developed with patient-partners to address the burden of hypoglycemia and assess impact of new therapies and technologies. The aim of the present report was to describe the baseline characteristics of the BETTER registry cohort.
Methods
Cross-sectional baseline evaluation of a Canadian clinical cohort established by online questionnaire. Participants were recruited through clinics, public foundations advertising and social media. As of February 2021, 1430 persons living with type 1 diabetes or latent-autoimmune diabetes (LADA) aged 14 years or older were enrolled. The trial was registered on clinicaltrials.gov: NCT03720197.
Results
Participants were (mean ± SD) 41.2 ± 15.7 years old with a diabetes duration of 22.0 ± 14.7 years, 62.0% females, 92.1% Caucasians, 7.8% self-reporting as LADA, 40.9% using a continuous subcutaneous insulin infusion system (CSII), and 78.0% a continuous glucose monitoring system (CGMs). Most recent A1C ≤ 7% was reported by 29.7% of participants. At least one episode of hypoglycemia < 3.0 mmol/L (level-2-H) in the last month was reported by 78.4% of participants, median 5 episodes [3.0-10.0]. The occurrence of severe hypoglycemia (level-3-H) in the last 12 months was reported by 13.3% of participants. Among those, the median number of episodes was 2.0 [1.0-3.0].
Conclusions
We established the first surveillance registry for people living with type 1 diabetes in Canada relying on patient-reported outcomes and experiences. Hypoglycemia is a highly prevalent burden despite a relatively wide adoption of CSII and CGM use.
Aims:
Mild-to-moderate hypoglycemia (blood glucose < 4.0 mmol/L) is recommended to be treated with 15 g of carbohydrates and to repeat the treatment if hypoglycemia persists after 15 min. This recommendation was established before intensive insulin therapy and based on studies using insulin with different pharmacokinetic profiles from actual insulin analogs showing that 15 g of glucose increases blood glucose by ~ 1.5 mmol/L in 15 min. We aimed to explore the effect of current recommended treatment of mild-to-moderate hypoglycemia in type 1 diabetes (T1D) participants and factors associated with treatment effectiveness.
Methods:
This is a secondary analysis from three observational inpatient studies with a standardized and supervised treatment (16 g carbohydrates) of hypoglycemia (< 3.3 mmol/L with symptoms or < 3.0 mmol/L without symptom) in participants (47 adults-10 adolescents) with T1D using continuous subcutaneous insulin infusion ("insulin pumps"; CSII)).
Results:
Twenty-seven participants presented a total of 48 hypoglycemia episodes treated by a single intake of 16 g of carbohydrates. Time required for normoglycemia recovery was 19.5 ± 12.0 min. The rise in plasma glucose following treatment was 0.85 ± 0.66 mmol/L in 15 min. Eighteen episodes (38%) were resolved (> 4.0 mmol/L) 15-min post-treatment. Glycemia at the time of treatment (< 3.2 mmol/L; p < 0.001) and a higher proportion of total daily insulin from basal doses (p = 0.03) were associated with a slower post-treatment plasma glucose rise.
Conclusions:
These results raise the possibility that sixteen grams of carbohydrates could be insufficient to treat a large proportion of hypoglycemia episodes in T1D patients treated with CSII. Factors affecting treatment effectiveness need to be investigated.
Continuous Glucose Monitoring (CGM) has been demonstrated to be clinically valuable, reducing risks of hypoglycemia and hyperglycemia, glycemic variability (GV), and improving patient quality of life for a wide range of patient populations and clinical indications. Use of CGM can help reduce HbA1c and mean glucose. One CGM device, with accuracy (%MARD) of approximately 10%, has recently been approved for self-adjustment of insulin dosages (nonadjuvant use) and approved for reimbursement for therapeutic use in the United States. CGM had previously been used off-label for that purpose. CGM has been demonstrated to be clinically useful in both type 1 and type 2 diabetes for patients receiving a wide variety of treatment regimens. CGM is beneficial for people using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). CGM is used both in retrospective (professional, masked) and real-time (personal, unmasked) modes: both approaches can be beneficial. When CGM is used to suspend insulin infusion when hypoglycemia is detected until glucose returns to a safe level (low-glucose suspend), there are benefits beyond sensor-augmented pump (SAP), with greater reduction in the risk of hypoglycemia. Predictive low-glucose suspend provides greater benefits in this regard. Closed-loop control with insulin provides further improvement in quality of glycemic control. A hybrid closed-loop system has recently been approved by the U.S. FDA. Closed-loop control using both insulin and glucagon can reduce risk of hypoglycemia even more. CGM facilitates rigorous evaluation of new forms of therapy, characterizing pharmacodynamics, assessing frequency and severity of hypo- and hyperglycemia, and characterizing several aspects of GV.
The role of glucagon in the pathophysiology of diabetes has long been recognized while its approved clinical use has so far been limited to the emergency treatment of severe hypoglycaemia. A novel use of glucagon as intermittent mini-boluses is proposed in the dual-hormone version (insulin and glucagon) of the external artificial pancreas. Short-term studies suggest that glucagon incorporation has the potential to further decrease the hypoglycaemic risk and improve the overall glucose control. However, long term potential safety and benefits need to be investigated given its recognised systemic effects of glucagon. In this report, we review the available animal and human data on the physiologic functions of glucagon as well as its pharmacological use according to dosing and duration (acute and chronic). Other than its main role in hepatic glucose metabolism, glucagon affects the cardiovascular, renal, pulmonary and gastrointestinal systems. It has a potential role in weight reduction through its central satiety function and increase in energy expenditure. Most of the pharmacological studies investigating the effects of glucagon have used doses exceeding 1 mg, in contrast to the mini-boluses used in the artificial pancreas. The available data is reassuring but comprehensive human studies using small but chronic glucagon doses that are close to the physiologic ranges are lacking. We propose a list of parameters that could be monitored during the long-term trials of the artificial pancreas. Such trials are expected to answer the questions about the risk-benefit ratio of chronic glucagon use.
Objectives:
1) To characterize the nutritional treatment of hypoglycemia in adult patients with type 1 diabetes mellitus and 2) to compare the characteristics of participants who follow the recommendations with the characteristics of those who do not.
Methods:
A total of 121 adults with type 1 diabetes were included in this cross-sectional analysis. Participants completed a food record and a glycemia and insulin doses logbook to collect data on mild to moderate hypoglycemic events (glycemia <4.0 mmol/L or 4.0 to 5.0 mmol/L with symptoms) and their treatments over a 2-day period. Participants were identified as overcorrecting if they consumed, within 15 minutes after the episode, >20g of carbohydrates for correction. Self-administered questionnaires about fear of hypoglycemia were completed, and cardiometabolic profile variables were measured (glycated hemoglobin, blood pressure, lipid profile and body mass indexes).
Results:
Of the 121 participants, 94 (78%) reported at least 1 hypoglycemic event, for a total of 271 events (2.2±2.1 episodes per patient). Of these events, 64% were treated within 15 minutes, and they were treated primarily with fruit juice or sweet beverages (39%) or mixed snacks (29%). Average carbohydrate intake for treatment was 32±24 grams. Of the participants, 73% overtreated their episodes. They were significantly younger and had greater fear of hypoglycemia than those who treated the episodes adequately. No difference was observed for cardiometabolic variables.
Conclusions:
The majority of patients in our cohort overtreated their hypoglycemic episodes. These results suggest that hypoglycemia-correction education needs to be reinforced.
Objective:
To evaluate mini-dose glucagon in adults with type 1 diabetes using a stable, liquid, ready-to-use preparation.
Research design and methods:
Twelve adults with type 1 diabetes receiving treatment with insulin pumps received subcutaneous doses of 75, 150, and 300 μg of nonaqueous glucagon. Plasma glucose, glucagon, and insulin concentrations were measured. At 180 min, subjects received insulin followed in ∼60 min by a second identical dose of glucagon.
Results:
Mean (±SE) fasting glucose concentrations (mg/dL) were 110 ± 7, 110 ± 10, and 109 ± 9 for the 75-, 150-, and 300-μg doses, respectively, increasing maximally at 60 min by 33, 64, and 95 mg/dL (all P < 0.001). The post-insulin administration glucose concentrations were 70 ± 2, 74 ± 5, and 70 ± 2 mg/dL, respectively, with maximal increases of 19, 24, and 43 mg/dL post-glucagon administration (P < 0.02) at 45-60 min.
Conclusions:
Subcutaneous, nonaqueous, ready-to-use G-Pen Mini glucagon may provide an alternative to oral carbohydrates for the management of anticipated, impending, or mild hypoglycemia in adults with type 1 diabetes.
The aging of the population is a worldwide phenomenon. The prevalence of diabetes rises with increasing age, so the personal and financial costs of diabetes in the aging population have become significant burdens. In 2012, 104 billion (59%) of the estimated $176 billion in United States healthcare expenditures attributable to diabetes were utilized by patients older than 65 years of age [American Diabetes Association (1)]. With improvement in diabetes management and better glycemic control in the general population, there is an increase in the prevalence of hypoglycemia, which is the complication of the treatment of diabetes. Older adults with diabetes have a higher risk for hypoglycemia due to altered adaptive physiologic responses to low glucose levels. These patients also have comorbidities, such as cognitive and functional loss, that interfere with prompt identification and/or appropriate treatment of hypoglycemia. Older adults who suffer from hypoglycemia also have increased risk for falls, fall-related fractures, seizures and comas and exacerbation of chronic conditions, such as cognitive dysfunction and cardiac events. Thus, hypoglycemia in the older adult must be proactively avoided to decrease significant morbidity and mortality. Education of the patients and caregivers is important in prevention and treatment of hypoglycemia. In this article, we discuss the important aspects and unique challenges pertaining to hypoglycemia in older population. We also highlight the risks, consequences and prevention and management strategies for hypoglycemia that can be used by healthcare providers caring for older populations.
Using a modification of the glucose clamp technique, we have studied the efficacy of commonly used foods to correct hypoglycemia in insulin-dependent diabetics. After lowering the plasma glucose level to 55 mg/dL at a steady-state plasma free insulin concentration of about 50 μU/mL, patients were fed 20 g of carbohydrate as milk, orange juice, or D-glucose or 40 g of carbohydrate as orange juice. The data indicate that 20 g of carbohydrate as D-glucose corrects hypoglycemia without rebound hyperglycemia. In an outpatient setting, this treatment also proved effective in spontaneous episodes of hypoglycemia. We conclude that (1) the D-glucose content of the ingested carbohydrate is an important determinant of the glycemic response, and (2) at times of moderately severe hypoglycemia, ingestion of 20 g of D-glucose provides an effective glycemic response for periods of at least 40 minutes. In view of these data, a table is provided listing some common sources of 20 g of D-glucose.
(JAMA 1984;252:3378-3381)
AimTo determine whether a weight-based hypoglycaemia treatment using 0.3 g/kg (or 0.2 g/kg) glucose effectively treats adults with Type 1 diabetes mellitus compared with an internationally recommended 15-g treatment.Methods
Patients with frequent hypoglycaemia were recruited from hospital-based diabetes clinics. The treatment for each hypoglycaemic episode, defined as capillary glucose <4.0 mmol/l, was randomly assigned to one of three protocols: 0.2g/kg, 0.3g/kg, or 15g, using Dextro™ glucose tablets (Dextro Energy, Krefeld, Germany). Each participant received each treatment in random order for up to 15 hypoglycaemic episodes. Glucose was re-tested 10 min after treatment, with a repeat dose if still < 4 mmol/l.ResultsThe study recruited 34 participants aged 22–71years, whose mean (sd) BMI was 25.2 (3.1) kg/m2 and HbA1c 63 (10.4) mmol/mol [7.9 (0.9)%]. Two people withdrew because they did not like the taste of the Dextro tablets and one was excluded because they used their own glucose preparation. Unadjusted for clustering within participants, the mean (sd) glucose after 10 min was 4.67 (1.25) mmol/l for 0.3g/kg (141 episodes), 4.29 (0.94) mmol/l for 0.2g/kg (132 episodes), and 4.37(0.99) mmol/l for 15g (136 episodes). Capillary glucose, adjusted for clusters and baseline glucose, was higher after 10 min for 0.3g/kg glucose compared with 15g glucose; a difference of 0.26 (95% CI 0.04–0.48) mmol/l (P=0.02), but not for 0.2g/kg; -0.07 (95% CI -0.29–0.16) mmol/l (P=0.56). Capillary glucose for only three hypoglycaemic episodes rose above 8 mmol/l.ConclusionsA weight-based protocol of 0.3g/kg glucose appears more effective for treating symptomatic hypoglycaemia in adults with Type 1 diabetes than either the most common current recommendation of 15g glucose or a 0.2g/kg glucose dose.This article is protected by copyright. All rights reserved.
BACKGROUND
Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.
METHODS
A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.
RESULTS
In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy. In the secondary-intervention cohort, intensive therapy slowed the progression of retinopathy by 54 percent (95 percent confidence interval, 39 to 66 percent) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent (95 percent confidence interval, 14 to 67 percent). In the two cohorts combined, intensive therapy reduced the occurrence of microalbuminuria (urinary albumin excretion of ≥ 40 mg per 24 hours) by 39 percent (95 percent confidence interval, 21 to 52 percent), that of albuminuria (urinary albumin excretion of ≥ 300 mg per 24 hours) by 54 percent (95 percent confidence interval, 19 to 74 percent), and that of clinical neuropathy by 60 percent (95 percent confidence interval, 38 to 74 percent). The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia.
CONCLUSIONS
Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM.
This article has been removed: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).
Please note that a special edition of Canadian Journal of Diabetes (Volume 39 Supplement 4) was published electronically in error and has since been removed. This edition was planned as a print-only reproduction of a selection of earlier published articles from Canadian Journal of Diabetes: electronic publication of the edition created duplicate items, and were therefore removed. The original articles remain and are unaffected. Andrew Miller, Executive Publisher.
Background: Appropriate self-treatment of mild symptomatic hypoglycaemia is essential to prevent severe hypoglycaemia. Danish national guidelines recommend 10–20 g of refined carbohydrate (CH) initially, followed by a non-specified amount of unrefined CH.Aim: Our aim was to explore the effect of the amount of CH taken on glucose concentrations recorded by the MiniMed Continuous Glucose Monitoring System (CGMS) at mild symptomatic hypoglycaemic episodes.Method: A total of 125 adult patients with type 1 diabetes underwent 6 days of CGMS. HemoCue blood glucose determinations were used for calibration. All mild symptomatic episodes with a concomitant CGMS value ≤ 3.5 mmol/l were included in the analysis. Participants completed a detailed diary documenting all meals and snacks, insulin doses, and episodes and self-treatment of hypoglycaemia. CGMS values recorded 30 and 60 minutes after the episode were compared to CH intake. An initial intake of <10 g CH was defined as under treatment, and an intake of >20 g CH as over treatment. Treatment target was CGMS values of 3.6–10.0 mmol/l; values ≤ 3.5 mmol/l were defined as insufficient treatment, and values >10.0 mmol/l as overshooting the target.Results: A total of 126 mild symptomatic episodes was experienced in 52 (42%) of the patients. Initial carbohydrate intake could be calculated for 93 episodes. At 30 minutes, under treatment was associated with increased risk of insufficient response (57% versus 30%; p<0.01). At 60 minutes, over treatment was associated with increased risk of overshooting the target (23% versus 7%; p<0.05). An independent effect of follow-up intake of unrefined CH is not detectable within the first 60 minutes after treatment.Conclusion: Current guidelines for treatment of mild symptomatic hypoglycaemia are appropriate to ensure achievement of the glycaemic target. Copyright © 2006 FEND.
To compare self-treatment of mild symptomatic hypoglycaemia in people with type 1 diabetes with national Danish guidelines recommending 10–20 g of refined carbohydrate initially followed by unrefined carbohydrates.
A cohort of 201 patients with type 1 diabetes filled in a questionnaire including self-treatment of mild symptomatic hypoglycaemia and occurrence of mild and severe hypoglycaemia. Initial intake of less than 10 g of refined carbohydrate was defined as under treatment and intake of 20 g or more as over treatment.
A total of 147 patients (73%) answered both questions about initial and follow-up self-treatment of hypoglycaemia. Fifty per cent of patients treated themselves with 10–20 g refined carbohydrates (female:male = 59%:43%; p<0.05), whereas 37% over treated (female:male = 34%:39%; not significant) and 13% under treated (female:male = 6%:18%; p<0.05). Initial treatment was followed by consumption of unrefined carbohydrates in 70% of the patients. Overall, 37% (female:male = 49%:28%; p<0.05) of the patients adhered to guidelines. The number of severe hypoglycaemic episodes (lifetime) and amount of carbohydrate intake were positively correlated (r = 0.2; p<0.05). Adherence to guidelines was not related to occurrence of mild and severe (in the last year) hypoglycaemia, glycated haemoglobin, or fear of hypoglycaemia.
Only about one-third of patients with type 1 diabetes treat mild hypoglycaemia according to guidelines. Female patients show better compliance. Patients with frequent episodes of severe hypoglycaemia over treat more often. Copyright
The search for an optimized treatment of hypoglycemia. Carbohydrates in tablets, solutin, or gel for the correction of insulin reactions
- Slama