Multiple Daily Injection Therapy Research Articles

Pharmacotherapy of type1 diabetes in children and adolescents: more than insulin?

For paediatric patients with type 1 diabetes, intensified insulin therapy with either multiple daily injection or insulin pump therapy is currently the only method of treatment. To optimize this therapy, insulin analogues are fixed parts of all therapy regimens. New ultra-rapid insulins seem to be beneficial not only in adults but also in this age group. New developments in long-acting analogues have demonstrated safety and will be regular in paediatrics, we hope, soon. Furthermore, the psychosocial approach for consideration of real-life aspects becomes more the focus of therapeutic regimens and is implemented into international guidelines. Technical improvements, such as continuous glucose monitoring, particularly in combination with pump therapy, support the great success of rapid-acting analogues by reducing hypoglycaemias. Non-insulin agents such as SGLT2-inhibitors show beneficial aspects in people with type 1 diabetes. For outpatient care with these currently off-label-used drugs, special training for measurement of ketones should be imperative.

Complex Assessment of Metabolic Effectiveness of Insulin Pump Therapy in Patients with Type 2 Diabetes Beyond HbA1c Reduction.

Background: This prospective single-center study recruited insulin-resistant continuous subcutaneous insulin infusion (CSII) therapy-naive patients with type 2 diabetes (T2D) using insulin analog-based multiple daily injections (MDI) therapy and metformin.Methods: A total of 23 individuals with T2D (70% male), aged a mean ± standard deviation 57.2 ± 8.03 years, with body mass index of 36.2 ± 7.02 kg/m2, diabetes duration of 13.3 ± 4.64 years, and HbA1c of 10.0% ± 1.05% were randomly assigned to a CSII arm or an MDI continuation arm to explore glucose control, weight loss, total daily insulin dose (TDD), and insulin resistance. Insulin dosing was optimized over a 2-month run-in period.Results: At 6 months, patients assigned to the CSII arm achieved a significant mean HbA1c reduction of −0.9% (95% confidence interval [CI] = −1.6, −0.1), while reducing their TDD by −29.8 ± 28.41 U/day (33% of baseline [92.1 ± 20.35 U/day]) and achieving body mass (BM) reduction of −0.8 ± 5.61 kg (0.98% of baseline [104.8 ± 16.15 kg]). MDI patients demonstrated a nonsignificant HbA1c reduction of −0.3% (95% CI = −0.8, 0.1) with a TDD reduction of 5% from baseline (99.0 ± 25.25 U/day to 94.3 ± 21.25 U/day), and a BM reduction of −1.0 ± 2.03 kg (0.99% of baseline [108.9 ± 20.55 kg]). After 6 months, the MDI arm crossed over to CSII therapy. At 12 months, patients continuing CSII demonstrated an additional mean 0.7% HbA1c reduction with 54.6% achieving HbA1c<8%. The final TDD reduction was −9.7 U/day in comparison to baseline; BM increased by 1.1 ± 6.5 kg from baseline. The MDI patients that crossed to CSII showed an HbA1c reduction of −0.5% ± 1.04%, HbA1c response rate of 27.3%, a TDD reduction of −17.4 ± 21.06 U/day, and a BM reduction of −0.3 ± 3.39 kg. Diabetic ketoacidosis or severe hypoglycemia did not occur in either arm.Conclusion: CSII therapy safely and significantly improved metabolic control with less insulin usage, with no sustainable reduction of BM, blood pressure, and lipid profile, in insulin-resistant T2D patients. Treatment adherence and satisfaction in these patients were excellent.

Rapid-acting and Regular Insulin are Equal for High Fat-Protein Meal in Individuals with Type 1 Diabetes Treated with Multiple Daily Injections.

IntroductionThe fat and protein content can impact late postprandial glycemia; therefore, prolonged insulin boluses for high-fat/-protein meals are recommended for patients with type 1 diabetes on insulin pump therapy. It is not clear how to translate these findings to multiple daily injection (MDI) therapy. We hypothesized that regular insulin with a slower onset and a longer duration of action might be advantageous for such meals.MethodsTwenty-five patients with well-controlled type 1 diabetes (mean HbA1c 6.8%, 51 mmol/mol, no episodes of hypoglycemia) on MDI therapy, aged 27.9 ± 4.3 years and well trained in flexible intensive insulin therapy, were given three test breakfasts with the same carbohydrate (CHO) content. The amount of fat and protein was low (LFP) or high (HFP). For LFP meals, patients received a rapid-acting insulin; for HFP meals, a rapid-acting or regular insulin was given in individual doses according to the CHO content and individual insulin-CHO ratios. Postprandial glycemia was determined by 6-h continuous glucose monitoring.ResultsAcute postprandial glucose levels measured for 2 h were similar after LFP and two HFP meals (7.8 ± 2.0, 8.1 ± 2.1, 8.0 ± 1.9 mmol/l). Late postprandial glycemia measured from 2 to 6 h was significantly lower after the LFP meal (6.7 ± 1.8 mmol/l, p < 0.05) than after the HFP meals, but there was no difference between the rapid-acting or regular insulin on HFP days (8.6 ± 2.6 and 8.9 ± 2.8 mmol/l, NS).ConclusionThe preliminary results of this study indicate no benefit to cover fat-protein meals with regular insulin in individuals with type 1 diabetes treated with MDI.

Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial

Aims/hypothesisEvidence for the effectiveness of interstitial glucose monitoring in individuals with type 1 diabetes using multiple daily injection (MDI) therapy is limited. In this pre-specified subgroup analysis of the Novel Glucose-Sensing Technology and Hypoglycemia in Type 1 Diabetes: a Multicentre, Non-masked, Randomised Controlled Trial’ (IMPACT), we assessed the impact of flash glucose technology on hypoglycaemia compared with capillary glucose monitoring.MethodsThis multicentre, prospective, non-masked, RCT enrolled adults from 23 European diabetes centres. Individuals were eligible to participate if they had well-controlled type 1 diabetes (diagnosed for ≥5 years), HbA1c ≤ 58 mmol/mol [7.5%], were using MDI therapy and on their current insulin regimen for ≥3 months, reported self-monitoring of blood glucose on a regular basis (equivalent to ≥3 times/day) for ≥2 months and were deemed technically capable of using flash glucose technology. Individuals were excluded if they were diagnosed with hypoglycaemia unawareness, had diabetic ketoacidosis or myocardial infarction in the preceding 6 months, had a known allergy to medical-grade adhesives, used continuous glucose monitoring (CGM) within the previous 4 months or were currently using CGM or sensor-augmented pump therapy, were pregnant or planning pregnancy or were receiving steroid therapy for any disorders. Following 2 weeks of blinded (to participants and investigator) sensor wear by all participants, participants with sensor data for more than 50% of the blinded wear period (or ≥650 individual sensor results) were randomly assigned, in a 1:1 ratio by a central interactive web response system (IWRS) using the biased-coin minimisation method, to flash sensor-based glucose monitoring (intervention group) or self-monitoring of capillary blood glucose (control group). The control group had two further 14 day blinded sensor-wear periods at the 3 and 6 month time points. Participants, investigators and staff were not masked to group allocation. The primary outcome was the change in time in hypoglycaemia (<3.9 mmol/l) between baseline and 6 months in the full analysis set.ResultsBetween 4 September 2014 and 12 February 2015, 167 participants using MDI were enrolled. After screening and the baseline phase, participants were randomised to intervention (n = 82) and control groups (n = 81). One woman from each group was excluded owing to pregnancy; the full analysis set included 161 randomised participants. At 6 months, mean time in hypoglycaemia was reduced by 46.0%, from 3.44 h/day to 1.86 h/day in the intervention group (baseline adjusted mean change, −1.65 h/day), and from 3.73 h/day to 3.66 h/day in the control group (baseline adjusted mean change, 0.00 h/day), with a between-group difference of −1.65 (95% CI −2.21, −1.09; p < 0.0001). For participants in the intervention group, the mean ± SD daily sensor scanning frequency was 14.7 ± 10.7 (median 12.3) and the mean number of self-monitored blood glucose tests performed per day reduced from 5.5 ± 2.0 (median 5.4) at baseline to 0.5 ± 1.0 (median 0.1). The baseline frequency of self-monitored blood glucose tests by control participants was maintained (from 5.6 ± 1.9 [median 5.2] to 5.5 ± 2.6 [median 5.1] per day). Treatment satisfaction and perception of hypo/hyperglycaemia were improved compared with control. No device-related hypoglycaemia or safety-related issues were reported. Nine serious adverse events were reported for eight participants (four in each group), none related to the device. Eight adverse events for six of the participants in the intervention group were also reported, which were related to sensor insertion/wear; four of these participants withdrew because of the adverse event.Conclusions/interpretationUse of flash glucose technology in type 1 diabetes controlled with MDI therapy significantly reduced time in hypoglycaemia without deterioration of HbA1c, and improved treatment satisfaction.Trial registration:ClinicalTrials.gov NCT02232698Funding:Abbott Diabetes Care, Witney, UK

Revisiting the Relationships Between Measures of Glycemic Control and Hypoglycemia in Continuous Glucose Monitoring Data Sets.

The Diabetes Control and Complications Trial (DCCT) identified an inverse relationship between HbA1c and severe hypoglycemia. We investigated the relationship between hypoglycemia and HbA1c in a large type 1 diabetes cohort on multiple daily injection or insulin pump therapy using blinded continuous glucose monitoring (CGM) data. The impact of real-time CGM on these relationships and how these relationships differ with biochemical definitions of hypoglycemia have also been assessed. CGM data were obtained from the JDRF CGM randomized control trial. Baseline blinded CGM data were used to assess time in hypoglycemia in all individuals. End point data from the CGM intervention group were used to assess the impact of CGM. Percentage of time spent below 3.9, 3.3, 3.0, and 2.8 mmol/L were calculated and quadratic regression plots drawn. Relationships were analyzed visually, and ANOVA was used to assess relationships between glycemia and time below threshold. J-shaped relationships were observed for all biochemical hypoglycemia thresholds, with the lowest hypoglycemia risk occurring at HbA1c values between 8.1 and 8.6% (65-70 mmol/mol). The use of an average of 5 days/week of CGM flattened the relationships for 3.3, 3.0, and 2.8 mmol/L, and ANOVA confirmed the loss of relationship for the 3.3 mmol/L threshold using CGM. The relationship between hypoglycemia and HbA1c in a population with type 1 diabetes is J-shaped. Lower HbA1c values are still associated with increased hypoglycemia risk, although the magnitude of risk depends on biochemical threshold. Real-time CGM may reduce the percentage time spent in hypoglycemia, changing the relationship between HbA1c and hypoglycemia.

Psychosocial outcomes in adults with type 1 diabetes following a novel ‘short course’ structured flexible MDI therapy self‐management programme

AbstractOur objectives were to evaluate the psychosocial impact of a novel education programme, comprising an abbreviated curriculum based on the ‘core elements’ of insulin self‐management education, with a view to identifying education options for those unable to attend a five‐day Dose Adjustment for Normal Eating (DAFNE) programme.The novel programme was developed by DAFNE course facilitators and trialled using participants naive to flexible multiple daily injection (MDI) education. Post‐course treatment satisfaction, wellbeing and diabetes distress were compared to baseline.Twenty‐one adults attended the programme and 16 participants returned three months post‐course. Significant improvements were seen in W‐BQ12 total score, PAID score and DTSQ, equivalent to those observed following participation in the five‐day programme.It was concluded that short course flexible MDI education is well tolerated by adults with type 1 diabetes, with improvements in treatment satisfaction and psychosocial outcome that are consistent with the five‐day DAFNE programme. Further investigation of the longer‐term impact on psychosocial and glycaemic outcomes of this novel curriculum is warranted. Copyright © 2017 John Wiley &amp; Sons.

Intensive insulin therapy combined with metformin is associated with reduction in both glucose variability and nocturnal hypoglycaemia in patients with type 2 diabetes.

The effect on glucose variability in patients with intensive insulin therapy has not been fully understood. This observational study investigated the different glucose variability and hypoglycaemia patterns in type 2 diabetes patients treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) with or without metformin administration. During hospitalization, a total of 501 patients with poor glycaemic control and in initial treatment with either CSII alone (n=187), CSII+Metformin (n=81), MDI alone (n=146), or MDI+Metformin (n=87) were involved in the final analysis. Data obtained from continuous glucose monitoring were used to assess blood glucose fluctuation and nocturnal hypoglycaemia. Among the 4 groups, no difference was found in mean blood glucose levels. Results in parameters reflecting glucose fluctuation: continuous overlapping net glycaemic action in CSII+Metformin and mean amplitude of glycaemic excursions in MDI+Metformin were significantly lower than those in either CSII alone or MDI alone, respectively, even after adjustment (P=.031 and .006). Frequency of nocturnal hypoglycaemia was significantly decreased in CSII+Metformin as compared with CSII alone (0.6% vs 1.8%) and in MDI+Metformin as compared with MDI alone (1.6% vs 2.3%), with the highest frequency observed in MDI alone and the lowest in CSII+Metformin (all between group P<.001). Consistent results were obtained in between-group comparisons for hypoglycaemia duration. Subgroup analysis matched with baseline body mass index, and glycated haemoglobin and fasting blood glucose further confirmed these findings. Metformin added to initial CSII or MDI therapy is associated with a reduction in both glucose fluctuation and nocturnal hypoglycaemic risk in patients with type 2 diabetes.

Satisfaction of switching to combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes receiving multiple daily insulin injection therapy: A randomized controlled trial.

Aims/IntroductionWe compared the satisfaction levels of patients with type 2 diabetes undergoing combination therapy with lixisenatide (LIX) and basal insulin with that of patients undergoing multiple daily insulin injection (MDI) therapy.Materials and MethodsThe study was a 12‐week open‐label, randomized, multicenter, controlled trial. Participants were Japanese patients with type 2 diabetes receiving MDI for >3 months. Patients were randomly assigned to each treatment cohort: (i) a group that continued MDI (MDI group); and (ii) a group that switched from MDI to combination therapy with LIX and basal insulin (LIX group). The primary outcome was change in Diabetes Treatment Satisfaction Questionnaire scores from baseline to 12 weeks between these two groups. Key secondary outcomes were glycated hemoglobin and body weight changes.ResultsA total of 31 patients were initially enrolled in the study, and 26 of them completed the study. The change in Diabetes Treatment Satisfaction Questionnaire scores in the LIX group was significantly greater compared with that in the MDI group. Mean changes in glycated hemoglobin levels were −0.05 ± 0.37% in the MDI group and 0.04 ± 0.38% in the LIX group (P = 0.36). Mean changes in body weight were +0.6 ± 1.8 kg in the MDI group and −2.5 ± 1.8 kg in the LIX group (P < 0.01).ConclusionsSwitching from MDI to combination therapy with LIX and basal insulin improved satisfaction levels while maintaining glycemic control in Japanese patients with type 2 diabetes.

Indian Injection Technique Study: Population Characteristics and Injection Practices.

IntroductionIt was estimated that 3.2 million Indians with diabetes injected insulin in 2010, but little is known about the techniques used.MethodsIn 2015 we conducted an injection technique questionnaire (ITQ) survey throughout India involving 1011 patients. Indian values were compared with those from 41 other countries participating in the ITQ, known here as rest of world (ROW).ResultsMean HbA1c was 8.6. BMI values in India were 1.5–3 units lower than in ROW depending on patient group, meaning the risk of intramuscular (IM) injections is high in India. The mean total daily dose (TDD) of insulin was lower in every category of Indian patient than in ROW, perhaps reflecting the lower BMI. Needle reuse, whether with pens or syringes, is much higher in India than ROW and so is the number of times the needle is used. The majority (56.8%) of Indian insulin users performed only 2 injections/day as opposed to ROW where 45% of patients performed at least 4 injections/day. Indian patients inject insulin in the thighs more often than patients in ROW, a site where IM injections are more risky. Many patients do not have proper access to sharps containers or have other risk factors that could lead to blood-borne pathogen spread. More than 60% of used sharps in India go into the rubbish, with nearly 12% not even having the minimum protection of a cap.DiscussionThe shortest needles are very common in India; however, the level of needle reuse is high. Multiple daily injections therapy is not as common in India as ROW. More focus needs to be given to dwell times under the skin, reconstitution of cloudy insulins, skinfolds, and safe sharps disposal.

Comparative study on treatment satisfaction and health perception in children and adolescents with type 1 diabetes mellitus on multiple daily injection of insulin, insulin pump and sensor-augmented pump therapy.

Objectives:Diabetes management imposes considerable demands on patients. Treatment method used has an impact on treatment satisfaction. We aim to examine the relationship between treatment satisfaction and health perception with the method used for treatment of type 1 diabetes mellitus in children and adolescents.Subjects and method:We have interviewed patients with type 1 diabetes mellitus using questionnaires to assess treatment satisfaction and health perception. Patients were divided into three groups based on treatment used: multiple daily injection, insulin pump and sensor-augmented pump therapy. Comparison of scores was done between the groups.Results:A total of 72 patients were enrolled (36 males). Mean age (standard deviation) was 11.4 (4.4) years and duration of diabetes of 4.9 (3.5) years. Mean (standard deviation) HbA1c was 8.1 (1.2). Median (range) duration of sensor use was 17.7 (3–30) days/month. Mean scale for treatment satisfaction and health perception questions was 25.3, 29.7 and 31.7 and 60, 79.7 and 81 for the multiple daily injection, pump and sensor-augmented pump, respectively (p = 0.00). Significant difference was seen between the multiple daily injection and both other groups. Sensor-augmented pump group scored higher than the pump group. However, the difference was not statistically significant. Duration of sensor use showed no correlation with treatment satisfaction.Conclusion:The method used for diabetes treatment has an impact on patients’ satisfaction and health perception in children and adolescents with type 1 diabetes mellitus. Insulin pump users have a higher treatment satisfaction and better health perception than those on multiple daily injection. Augmenting pump therapy with sensor use adds value to treatment satisfaction without correlation with the duration of the sensors use.

Multicentre randomized controlled trial with sensor-augmented pump vs multiple daily injections in hospitalized patients with type 2 diabetes in China: Time to reach target glucose

AimSensor-augmented pump (SAP) technology, which combines continuous subcutaneous insulin infusion (CSII) and real-time continuous glucose monitoring (RT-CGM), has been available for several years in China. In this study, the time required to reach predefined glycaemic targets with SAP vs multiple daily injection (MDI) therapy was compared in hospitalized patients with type 2 diabetes mellitus (T2DM). MethodsAdults (aged 18–65 years) with T2DM treated with insulin and admitted to hospital for glucose management were randomized to either SAP (Medtronic MiniMed™ Paradigm™ 722 system) or MDI with blinded CGM (Medtronic MiniMed CGMS System Gold™) for a 2-week period. Glycaemic targets were defined as three preprandial measurements between 80 and 130mg/dL (4.4 and 7.2mmol/L) and three 2-h postprandial measurements between 80 and 180mg/dL (4.4 and 10.0mmol/L) within the same day. ResultsWhen data from 81 patients (40 SAP, 41 MDI) were analysed, 21 patients using SAP therapy, compared with six using MDI therapy, achieved their glycaemic targets within 3 days, and their time to reach their glucose targets was significantly shorter (3.7±1.1 vs 6.3±3.1 days for MDI; P<0.001), while three MDI patients failed to reach glycaemic targets within 14 days. SAP vs MDI patients experienced significantly less hypoglycaemia [sensor glucose<50mg/dL (2.8mmol/L): 0.04% vs 0.32%, respectively; P<0.05] and significantly less hyperglycaemia [sensor glucose>180mg/dL (10mmol/L): 21.56% vs 35.03%, respectively; P<0.05]. ConclusionSAP vs MDI therapy in hospitalized patients with T2DM significantly reduced the time required to achieve glycaemic targets, and such systems may be a cost-effective way to improve glucose control and reduce hospital stays in T2DM patients.

Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization.

Real-time continuous glucose monitoring (rtCGM) improves glycemic control in type 1 diabetes (T1D) patients treated with continuous subcutaneous insulin infusion (CSII). However, the benefits of rtCGM in T1D patients treated with multiple daily insulin injection (MDI) therapy has not been well studied. We explored the effects of rtCGM versus self-monitoring of blood glucose (SMBG) on clinical outcomes within a large T1D population treated with either CSII or MDI therapy. This retrospective, longitudinal analysis utilized datasets from T1D patients enrolled in a commercial health plan to assess changes in HbA1c in 187 naïve to rtCGM users and 6260 SMBG users. Propensity score modeling was used to assess inpatient admissions, emergency room (ER) visits in 1130 patients (565 rtCGM, 565 SMBG). Differences in HbA1c reduction (rtCGM+MDI vs rtCGM+CSII) were evaluated. Larger, clinically meaningful HbA1c reductions were seen among rtCGM versus SMBG users: -0.5% ( P = .004) versus -0.2% ( P < .0001); 0.3% diff in diff, P = .03. All-cause inpatient admissions were lower for rtCGM users: -42%, P = .013. Emergency room visits coded for diabetic ketoacidosis (DKA) were four times higher for SMBG patients than rtCGM patients: 17 versus 4, P = .0318. HbA1c reductions were most notable with rtCGM+MDI versus rtCGM+CSII treatment: -0.6% ( P = .01) versus -0.3% ( P = .16). Use of rtCGM in T1D patients facilitates greater HbA1c improvements and reduced health care system utilization compared with traditional SMBG use regardless of insulin administration method. Treatment with rtCGM in conjunction with MDI confers similar or greater glycemic benefits without the additional costs associated with CSII therapy.

Comparing Lifestyle Convenience of Multiple Daily Injection and Continuous Subcutaneous Insulin Infusion

Aim: This study investigated the lifestyle convenience of Insulin therapy for adult women patients with type 1 diabetes. Methods: Participants were type 1 diabetes adult women patients who switched from multiple daily injection (MDI) therapy to Continuous Subcutaneous Insulin Infusion (CSII) therapy. We conducted semi-structured interviews with participants. To analyze, we referenced the classification table of Hamada’s study comparing the usefulness of both the NovoPen? and CSII. Semi-structured interviews were conducted with the research subjects. The questions focused mainly on diabetes management, instrument operation, everyday life, and social, psychological and lifestyle convenience aspects during MDI and CSII. Results: Research subjects were 4 women patients with type 1 diabetes. The average age was 35.3 ± 6.24 (SE) years old. Participants were undergoing MDI therapy; however, in the middle, they switched to CSII therapy. CSII therapy is convenient in terms of diabetes management, social and psychological. MDI therapy is convenient in terms of instrument operation and daily life. Compared to MDI therapy, CSII therapy is less convenient in terms of instrument operation and everyday life. However, since CSII therapy has more stable HbA1c and blood glucose levels compared to MDI therapy, it is more convenient in terms of social and psychological aspects and reduces those burdens. About economy CSII therapy, patients paid about 5000 yen more per month compared to MDI therapy. Conclusion: It is believed that patients prioritize therapeutic effects, and choose CSII, which is stable in psychological and social aspects, even though it is inconvenient with life.

Effects of advanced carbohydrate counting guided by an automated bolus calculator in Type 1 diabetes mellitus (StenoABC): a 12‐month, randomized clinical trial

To test whether concomitant use of an automated bolus calculator for people with Type 1 diabetes carrying out advanced carbohydrate counting would induce further improvements in metabolic control. We conducted a 12-month, randomized, parallel-group, open-label, single-centre, investigator-initiated clinical study. We enrolled advanced carbohydrate counting-naïve adults with Type 1 diabetes and HbA1c levels 64-100 mmol/mol (8.0-11.3%), who were receiving multiple daily insulin injection therapy. In a 1:1-ratio, participants were randomized to receive training in either advanced carbohydrate counting using mental calculations (MC group) or advanced carbohydrate counting using an automated bolus calculator (ABC group) during a 3.5-h group training course. For 12 months after training, participants attended a specialized diabetes centre quarterly. The primary outcome was change in HbA1c from baseline to 12 months. Between August 2012 and September 2013, 168 participants (96 men and 72 women) were recruited and randomly assigned to the MC group (n = 84) and the ABC group (n = 84). Drop-out rates were 23.8 and 21.4%, respectively (P = 0.712); 130 participants completed the study. The baseline HbA1c was 75 ± 9 mmol/mol (9.0 ± 0.8%) in the MC group and 74 ± 8 mmol/mol (8.9 ± 0.7%) in the ABC group. At 12 months, change in HbA1c was significant within both groups: MC group: -2 mmol/mol (95% CI -4 to -1) or -0.2% (95% CI -0.4 to -0.1; P = 0.017) and ABC group: -5 mmol/mol (95% CI -6 to -3) or -0.5% (95% CI -0.6 to -0.3; P < 0.0001), but HbA1c reductions were significantly greater in the ABC group (P = 0.033). No episodes of severe hypoglycaemia were reported. People with Type 1 diabetes initiating advanced carbohydrate counting obtained significantly greater HbA1c reductions when guided by an automated bolus calculator (NCT02084498).

Qualitative assessment of user experiences of a novel smart phone application designed to support flexible intensive insulin therapy in type 1 diabetes.

BackgroundModern flexible multiple daily injection (MDI) therapy requires people with diabetes to manage complex mathematical calculations to determine insulin doses on a day to day basis. Automated bolus calculators assist with these calculations, add additional functionality to protect against hypoglycaemia and enhance the record keeping process, however uptake and use depends on the devices meeting the needs of the user. We aimed to obtain user feedback on the usability of a mobile phone bolus calculator application in adults with T1DM to inform future development of mobile phone diabetes support applications.MethodsAdults with T1DM who had previously received education in flexible MDI therapy were invited to participate. Eligible respondents attended app education and one month later participated in a focus group to provide feedback on the features of the app in relation to usability for patient-based flexible MDI and future app development.ResultsSeven adults participated in the app training and follow up interview. App features that support dose adjustment to reduce hypoglycaemia risk and features that enable greater efficiency in dose calculation, record keeping and report generation were highly valued.ConclusionsAdults who are self managing flexible MDI found the Rapidcalc mobile phone app to be a useful self-management tool and additional features to further improve usability, such as connectivity with BG meter and food databases, shortcut options to economise data entry and web based storage of data, were identified. Further work is needed to ascertain specific features and benefit for those with lower health literacy.

The Calculating Boluses on Multiple Daily Injections (CBMDI) study: A randomized controlled trial on the effect on metabolic control of adding a bolus calculator to multiple daily injections in people with type 1 diabetes.

Although the insulin bolus calculator is increasingly being used by people with type 1 diabetes (T1D) on multiple daily injection (MDI) therapy, few studies have investigated its effects on glycemic control. The aim of this study was to determine whether adding this device to therapeutic intensification could further improve metabolic control. A 4-month randomized controlled clinical trial was performed comparing subjects undergoing therapeutic intensification and either using the bolus calculator (Cb group) or not (active control [Co] group). Metabolic control, fear of hypoglycemia, and treatment acceptance were evaluated. In all, 70 people completed the study (42 in the Cb group, 28 in the Co group). There was a significant decrease in HbA1c in both the Cb and Co groups (-7 mmol/mol [-0.7%] vs -4 mmol/mol [-0.4%], respectively). There were no significant differences in HbA1c at baseline or the end of the study, or in the decrease in HbA1c, glycemia, or changes in blood glucose levels at the end of the study between the two groups. There was a significant increase in the number of participants with good metabolic control (HbA1c <58 mmol/mol [7.5%]) in the Cb group (from 16.7% to 40.5%), but not in the Co group. The incidence of hypoglycemic events was reduced slightly but significantly only in the Cb group. There was no change in the fear of hypoglycemia at the end of the study. The bolus calculator was well accepted. In T1D, adding a bolus calculator to intensive MDI resulted in a significant improvement in metabolic control and slightly decreased the number of hypoglycemic episodes. Metabolic control also improved in the Co group.

Use and Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Multiple Daily Insulin Injection Therapy (MIT) in Children, Adolescents and Young Adults with Type 1 Diabetes Mellitus.

Today continuous subcutaneous insulin infusion (CSII) is frequently used in children and adolescents with type 1 diabetes mellitus. The present cross-sectional trial aimed to document current practice, quality of diabetes control and incidence of acute complications in different age-groups under CSII vs. multiple daily insulin injection therapy (MIT). Moreover the survey analyzed socio-demographic backgrounds of the patients. A total of 901 patients (age 11.5±4.0, diabetes duration 4.0±3.6 years) was entered in the database. Clinical data, laboratory parameters and, using a standardized questionnaire, socio-demographic data were assessed. For age-related analyses patients were allocated to 4 groups: pre-school children (< 6 years), pre-adolescents (≥ 6 and<11 years), adolescents (≥ 11 and<16 years) and young adults (≥ 16 and<22 years). Of the cohort n=194 had a CSII, n=707 had a MIT. Patients with CSII vs. MIT had a longer diabetes duration, they used more frequently insulin analogues, performed more frequently blood-glucose self-tests and had a lower insulin dosage per kilogram body weight. In respect of HbA1c, the mean amplitude of blood-glucose excursions, but also of lipids, creatinine, microalbuminuria and blood pressure, there were no differences in neither age-group between patients with CSII and MIT. In patients with CSII and MIT, there was a tendency (p<0.05) towards an increase in HbA1c in adolescents and young adults and there was a decrease (p<0.05 for tendency) in the frequency of hypoglycaemia from the age group of young adults to pre-school children. Adolescents and young adults with CSII had a higher educational level. Pre-adolescents, adolescents and young adults with CSII have also better diabetes-related knowledge. Moreover, in all age-groups, the parents of patients with CSII had mostly a lower unemployment rate and higher educational levels. The present analyses demonstrate that in all age-groups CSII provides convenient and flexible insulin delivery during routine treatment of type 1 diabetes. There is reasonable quality of diabetes control accompanied by a low incidence of hypoglycaemia and ketoacidosis. However, under CSII and MIT there is an increase of HbA1c towards adolescence. It must also highlighted that CSII seems to be expansive and that CSII is more frequently used in patients with better educational levels and deriving from higher social classes.

Glycemic control for type 1 diabetic children in Tripoli children Hospital, Tripoli, Libya

Background: Management of type 1 DM (T1DM) has changed dramatically over the past 30 years. Newer insulin regimens improved the ability to maintain nearnormal glycaemia safely. We aimed to audit our experience with two different strategies of insulin therapy namely premixed insulin (BD) and multiple daily injections (MDI) by assessment of well being, glycemic control and risk of acute complications. Patients and Methods: Patients T1DM for at least 1year who are attending at the endocrine clinic in Tripoli Children's Hospital between 2006 and 2007 were studied. Patients who were on BD insulin and got changed to MDI insulin were reviewed (20 patients) and those who on BD insulin and poor diabetic control (HbA1C &gt; 9) were switched to MDI and were followed up for 1 year. The age of patients at the time of diagnosis of DM ranged from 2-16 years (mean 8.2±3.2 years). Results: 88% of patients were on twice daily therapy for about 1-6 years before they were switched to MDI; when we reviewed patient's age at starting MDI, our patients can be divided in 2 groups, 1st group includes patients aged from 2-7yrs (younger age group) and they were on twice daily therapy and second group patients aged from 8-16 years with mean age 13yrs±2.4years on MDI. After one year of follow up, 70% had normal weight, 24% were underweight and 6% were overweight. 2% of patients on BD insulin had HbA1c &lt;7% improved to 26% after one year on MDI. 30% of those on BD insulin had acceptable HbA1c 7-9% which improved to 56%after one year on MDI. 68% of those on BD insulin with poor glycemic control (HbA1c&gt;9%) improved to 18% on MDI for one year (P&lt;0.001 for all groups). Hypoglycemia occurred in 26% of patients on BD insulin therapy reduced to only 2% after they were switched to MDI. Diabetic ketoacidosis (DKA), occurred in 14% of patients on BD insulin therapy reduced to none in children on MDI therapy. Conclusion: Most of our patients who has received MDI have better growth, glycemic control and experienced less hypoglycemia and DKA. We recommend generalization of intensive insulin therapy as the standard of care to all our patients.

Unknown Safety and Efficacy of Smartphone Bolus Calculator Apps Puts Patients at Risk for Severe Adverse Outcomes.

Manual calculation of bolus insulin dosages can be challenging for individuals treated with multiple daily insulin injections (MDI) therapy. Automated bolus calculator capability has recently been made available via enhanced blood glucose meters and smartphone apps. Use of this technology has been shown to improve glycemic control and reduce glycemic variability without changing hypoglycemia; however, the clinical utility of app-based bolus calculators has not been demonstrated. Moreover, recent evidence challenges the safety and efficacy of these smartphone apps. Although the ability to automatically calculate bolus insulin dosages addresses a critical need of MDI-treated individuals, this technology raises concerns about efficacy of treatment and the protection of patient safety. This article discusses key issues and considerations associated with automated bolus calculator use.

NOCTURNAL HYPOGLYCEMIA--THE MAIN INDICATION FOR INSULIN PUMP THERAPY IN ADULTHOOD.

The aim was to determine which adult type 1 diabetic patient receiving multiple daily injection therapy is the most appropriate candidate for insulin pump therapy, while taking into consideration limited insulin pump affordability in Croatia. A total of 145 type 1 diabetic patients (52% diagnosed in adult age) were monitored at the Department of Endocrinology, Clinical Department of Internal Medicine, Zagreb University Hospital Center from 2009 to 2014. Twenty-one patients started insulin pump therapy in adulthood (seven men and 14 women, median age 27). Five patients had chronic complications (retinopathy in two, polyneuropathy in one, and both nephropathy and retinopathy in two patients). The median HbA1c at the initiation of pump therapy was 6.95% versus 6.5% after 1 year of pump therapy. Patients were stratified according to indications for insulin pump therapy (frequent and/or severe hypoglycemia, specific lifestyle, having not reached glycemic goals despite adherence/labile diabetes, and preconception). Patients could meet more than one criterion. Initially, the occurrence of hypoglycemia was analyzed by 6-day continuous glucose monitoring, while re-evaluation was done after collecting history data at 1 year ± 3 months. Initially, all patients had a median of 5 hypoglycemias/6 days (30% nocturnal) versus 1 hypoglycemia/6 days (without nocturnal) after 1 year. The Wilcoxon signed-rank test yielded a statistically significant difference in hypoglycemic events, nocturnal hypoglycemia and HbA1c. Patients commencing insulin pump therapy due to hypoglycemia initially had median HbA1c of 6.7% with 7 hypoglycemia/6 days (50% nocturnal). After one year, median HbA1c was 6% with 1 hypoglycemia/6 days (without nocturnal). In conclusion, the main indication for insulin pump therapy in adults is the frequency of hypoglycemia, especially nocturnal ones.